Regulations Governing Good Manufacturing Practices for Medical Products  
 
 
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REGULATIONS GOVERNING MANUFACTURING 
PRACTICES OF MEDICAL PRODUCTS  
(Rwanda FDA law No 003/2018 of 09/02/2018, Article 9)  
 
 
 
 
 Regulations Governing Good Manufacturing Practices for Medical Products  
 
 
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REGULATION DEVELOPME NT HISTORY  
 
 
DOCUMENT REVISION HI STORY  
  
  
Regulations Governing Good Manufacturing Practices for Medical Products  
 
 
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28/08 /2022  2 1. Streamlined regulation as per the 
recommendation from SOP on Document 
control ODG/QMS/SOP/001  
2. Editorial Changes were done  
3. Requirements for different articles were 
removed from the Regulations governing GMP 
of Medical Products and moved to the various 
guidelines.  
4. Article 10: The article for reliance was renamed 
reliance/recognition since the criteria for both 
activities were similar. Also the word Stringent 
Regulatory Authority was replaced by the new 
terminology WLA (WHO Listed Authority)  
5. Articles 11 a nd 12: Desk review and Virtual 
inspection: The criteria for Desk review and 
Virtual inspections were removed and inserted 
into the relevant guidelines.  
6. Article 14: Certificate and Validity. Here the 
validity of the GMP certificate for both 
domestic and for eign sites was aligned.  
7. Definition: added definition for Active 
Pharmaceutical Ingredient.  
 
Added Articles;  
8. Article 5: obligation of manufacturer to get 
GMP certificate  
9. Article 6: Language: This article describes the 
language of official documents for GMP 
applications.  
10. Article 7: Authenticity of Documents  
This article describes the responsibility of the 
applicant to provide reliable documents and the 
authority of Rwanda FDA to reject documents 
considered not to be authentic  
11. Article 8: Safe custody and confidentiality of 
information: This article describes the 
responsibility of the Authority to safeguard 
applicants’ information.  
12. Article 9: Assessment of GMP application. This 
article describes how applicants’ dossiers are 
assessed and how communication is  done 
between the Authority and the applicant   
  
Regulations Governing Good Manufacturing Practices for Medical Products  
 
 
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13. Article 13: This article describes the criteria for 
considering applicants for temporary waivers of 
onsite inspection during emergency states  
14. Article 145: Warnings, suspensions, and 
revocations: This article de tails when the 
Authority can take these actions against an 
applicant.  
15. Article 146: restoration of a suspended or 
revoked GMP certificate. This article details 
when the Authority can take such actions 
against a suspended or revoked GMP 
certificate.  
16. Article 89: on Transport and delivery validation 
was added.  
 
 
   
  
Regulations Governing Good Manufacturing Practices for Medical Products  
 
 
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ADOPTION AND APPROVA L OF THE REGULATIONS  
 
 
   
  
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TABLE OF CONTENTS  
REGULATION DEVELOPME NT HISTORY  ................................ ................................ ...................  2 
DOCUMENT REVISION HI STORY  ................................ ................................ ................................ . 2 
ADOPTION AND APPROVA L OF THE REGULATIONS  ................................ .............................  5 
CHAPTER ONE: GENERAL  PROVISIONS ................................ ................................ ...................  11 
ARTICLE ONE:  PURPOSE OF THESE RE GULATIONS  ................................ .............................  11 
ARTICLE 2: CITATION  ................................ ................................ ................................ ..................  11 
ARTICLE 3: SCOPE  ................................ ................................ ................................ .........................  11 
ARTICLE 4: DEFINITIO NS ................................ ................................ ................................ ............  11 
CHAPTER II: GOOD MAN UFACTURING PRACTICE INSPECTION  ................................ ....... 13 
ARTICLE 5: OBLIGATIO N TO OBTAIN GMP CERT IFICATE  ................................ ..................  13 
ARTIC LE 6: APPLICATION FO R GMP  ................................ ................................ .........................  14 
ARTICLE 7: LANGUAGE  ................................ ................................ ................................ ...............  14 
ARTICLE 8: AUTHENTIC ITY OF DOCUMENTS  ................................ ................................ ........  14 
ARTICLE 9: SAFE CUSTODY AND CON FIDENTIALITY OF INFO RMATION  ......................  14 
ARTICLE 10: ASSESSME NT OF GMP APPLICATIO NS................................ .............................  14 
ARTICLE 11: RELIANCE  AND RECOGNITION ................................ ................................ ..........  15 
ARTICLE 12: DESK REV IEW  ................................ ................................ ................................ ........  15 
ARTICLE 13: VIRTUAL INSPECTIONS  ................................ ................................ .......................  15 
ARTICLE 14: TEMPORAR Y WAIVERS OF ONSITE INSPECTION DURING EM ERGENCY 
STATES  ................................ ................................ ................................ ................................ .............  15 
ARTICLE 15: CERTIFIC ATE AND VALIDITY  ................................ ................................ ............  16 
CHAPTER III: QUALITY  MANAGEMENT PRINCIPL ES ................................ ...........................  16 
ARTICLE 16: QUALITY ASSURANCE SYSTEM  ................................ ................................ ........  16 
ARTICLE 17: GOOD MAN UFACTURING PRACTICES  ................................ .............................  16 
ARTICLE 18: QUALITY CONTROL  ................................ ................................ ..............................  16 
ARTICLE 19: QUALITY CONTR OL REQUIREMENTS  ................................ ..............................  16 
ARTICLE 20: PRODUCT QUALITY REVIEW  ................................ ................................ .............  16 
ARTICLE 21: QUALITY RISK MANAGEMENT  ................................ ................................ ..........  17 
ARTICLE 22: SANITATI ON AND HYGIENE  ................................ ................................ ...............  17 
CHAPTER IV: PERSONN EL ................................ ................................ ................................ ...........  17 
ARTICLE 23: PRINCIPL ES GOVERNING PERSONN EL ................................ ............................  17 
ARTICLE 24: KEY PERS ONNEL  ................................ ................................ ................................ ... 17 
ARTICLE 25: ACADEMIC  QUALIFICATIONS OF K EY PERSONNEL  ................................ .... 18 
ARTICLE 26: TRAINING  ................................ ................................ ................................ ................  18 
ARTICLE 27: PERSONAL  HYGIENE  ................................ ................................ ............................  18 
CHAPTER V: PREMISES  ................................ ................................ ................................ ................  18 
ARTICLE 28: LAYOUT A ND DESIGN  ................................ ................................ ..........................  18 
ARTICLE 29: PRODUCTI ON AREA  ................................ ................................ ..............................  18 
ARTICLE 30: STORAGE AREA  ................................ ................................ ................................ ..... 19 
ARTICLE 31: WEIGHING  AREAS  ................................ ................................ ................................ . 19 
ARTICLE 32: QUALITY CONTROL AREAS  ................................ ................................ ................  19 
ARTICLE 33: ANCILLAR Y AREAS  ................................ ................................ ..............................  19  
  
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CHAPTER VI: EQUIPMEN T ................................ ................................ ................................ ...........  20 
ART ICLE 34: DESIGN AND LOCATION OF MANUFACT URING EQUIPMENT  ...................  20 
ARTICLE 35: MANUFACT URING EQUIPMENT  ................................ ................................ ........  20 
CHAPTER VII: DOCUMEN TATION  ................................ ................................ .............................  20 
ARTICLE 36: GOOD DOC UMENTATION PRACTICE  ................................ ...............................  20 
ARTICLE  37: P REPARED DOCUMENT  ................................ ................................ .......................  20 
ARTICLE  38: L ABELS  ................................ ................................ ................................ ....................  21 
CHAPTER VIII: PRODUC TION  ................................ ................................ ................................ ..... 21 
ARTICLE 39: PRODUCTION OPERATI ON ................................ ................................ ..................  21 
ARTICLE  40: HANDLING PRODUCTS  ................................ ................................ ........................  21 
ARTICLE  41: CROSS CONTAMINATIO N AND BACTERIAL CONT AMINATION IN 
PRODUCTION ................................ ................................ ................................ ................................ .. 21 
CHAPTER IX: GOOD PRA CTICES IN QUALITY CO NTROL  ................................ ....................  22 
ARTICLE  42: QUALITY  ................................ ................................ ................................ ..................  22 
ARTICLE  43: DEPARTMENT AND LABO RATORY  ................................ ................................ .. 22 
ARTICLE  44: DOC UMENTATION  ................................ ................................ ................................  22 
ARTICLE  45: SAMPLING  ................................ ................................ ................................ ...............  22 
ARTICLE  46: STARTING MATERIALS AND INTERMEDIATE PRO DUCTS  .........................  23 
ARTICLE  47: TEST REQUIREMENTS  ................................ ................................ ..........................  23 
ARTICLE  48: IN-PROCESS CONTROL ................................ ................................ .........................  23 
ARTICLE  49: FINISHED PRODUCTS  ................................ ................................ ...........................  23 
ARTICLE 50: BATCH RECOR D REVIEW  ................................ ................................ ....................  23 
ARTICLE  51: STABILITY STUDIES  ................................ ................................ .............................  23 
ARTICLE  52: REAGENTS AND CULTUR E MEDIA  ................................ ................................ ... 23 
ARTICLE  53: REFERENCE STANDARDS  ................................ ................................ ...................  24 
CHAPTER X: CONTRACT ................................ ................................ ................................ ..............  24 
ARTICLE  54: CONTRACTUAL ARRANGEM ENTS  ................................ ................................ .... 24 
ARTICLE  55: OBLIGATION OF PARTI ES TO CONTRACT  ................................ ......................  24 
ARTICLE  56: ESSENTIAL REQUIREME NTS OF THE CONTRACT  ................................ .........  24 
CHAPTER XI: COMPLAIN TS HANDLING AND PROD UCT RECALL  ................................ .... 25 
ARTICLE  57: COMPLAINTS HA NDLING  ................................ ................................ ....................  25 
ARTICLE  58: PRODUCT RECALL  ................................ ................................ ................................  25 
CHAPTER XII: SELF -INSPECTION, QUALITY AU DITS, SUPPLIER AUDIT S, AND 
APPROVALS  ................................ ................................ ................................ ................................ .... 25 
ARTICLE 59: SELF -INSPECTION  ................................ ................................ ................................ . 25 
ARTICLE  60: ITEMS FOR SELF -INSP ECTION ................................ ................................ ............  25 
ARTICLE  61: SELF -INSPECTION TEA M ................................ ................................ .....................  25 
ARTICLE  62: FREQUENCY OF SELF -INSPECTION  ................................ ................................ .. 25 
ARTICLE  63: SELF -INSPECTION REP ORT  ................................ ................................ .................  26 
ARTICLE  64: FOLLOW -UP ACTION  ................................ ................................ ............................  26 
ARTICLE  65: AUDITS, A ND APPROVAL  ................................ ................................ ....................  26 
CHAPTER XIII: MANUFA CTURE OF STERILE MED ICINAL PRODUCTS  ............................  26 
ARTICLE  66: STERILE MEDICINAL P RODUCTS  ................................ ................................ ...... 26  
  
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ARTICLE  67: ISOLATOR TECHNOLOGY  ................................ ................................ ...................  26 
ARTICLE  68: PERSONNEL  ................................ ................................ ................................ ............  26 
ARTICLE  69: PREMISES  ................................ ................................ ................................ ................  27 
ARTICLE  70: EQUIPMENT  ................................ ................................ ................................ ............  27 
ARTICLE  71: SANITATION  ................................ ................................ ................................ ...........  27 
ARTICLE  72: PROCESSING  ................................ ................................ ................................ ...........  27 
ARTICLE  73: PROCESSING STERILIZ ATION  ................................ ................................ ............  28 
CHAPTER XIV: BIOLOGI CAL MEDICINAL PRODUC TS FOR HUMAN USE  ........................  28 
ARTICLE  74: BIOLOGICAL MEDICINA L PRODUCTS ................................ ..............................  28 
ARTICLE  75: PERSONNEL  ................................ ................................ ................................ ............  28 
ARTICLE  76: PREMISES AND EQUIPM ENT  ................................ ................................ ..............  28 
ARTICLE  77: ANIMAL QUARTERS AND  CARE PRODUCTION  ................................ .............  28 
CHAPTER XV: VALIDATI ON AND QUALIFICATION ................................ ..............................  28 
ARTICLE  78: VALIDATION  ................................ ................................ ................................ ..........  28 
ARTICLE  79: VALIDATION ACTIVITI ES ................................ ................................ ...................  29 
ARTICLE  80: DOCUMENTATION  ................................ ................................ ................................  29 
ARTICLE 81: DESIGN QUALIFICATIO N................................ ................................ .....................  29 
ARTICLE  82: INSTALLATION QUALIF ICATION  ................................ ................................ ...... 29 
ARTICLE  83: OPE RATIONAL QUALIFICATI ON ................................ ................................ ....... 29 
ARTICLE  84: PERFORMANCE QUALIFI CATION  ................................ ................................ ...... 29 
ARTICLE  85: QUALIFICATION OF ES TABLISHED FACILITIES , SYSTEMS, AND 
EQUIPMENT  ................................ ................................ ................................ ................................ .... 29 
ARTICLE  86: PROCESS VALIDATION  ................................ ................................ ........................  29 
ARTICLE 87: CLEANING VALIDATION  ................................ ................................ .....................  30 
ARTICLE 88: TRANSPOR T AND DELIVERY VALIDA TION  ................................ ...................  30 
ARTICLE  89: CHANGE CONTROL  ................................ ................................ ...............................  30 
ARTICLE  90: REVALIDATION  ................................ ................................ ................................ ..... 30 
CHAPTER XVI: DIGITAL IZED SYSTEM  ................................ ................................ .....................  30 
ARTICLE  91: COMPUTERI ZED SYSTEMS  ................................ ................................ .................  30 
ARTICLE  92: VALIDATION  ................................ ................................ ................................ ..........  30 
ARTICLE  93: HANDLING OF SYSTEM  ................................ ................................ .......................  30 
CHAPTER XVII: WATER FOR PHARMACEUTICAL U SE ................................ ........................  31 
ARTICLE  94: PHARMACEUTICAL WATE R SYSTEM  ................................ ..............................  31 
ARTICLE  95: WATER QUALITY SPECI FICATIONS  ................................ ................................ .. 31 
ARTICLE  96: DRINKING WATER  ................................ ................................ ................................  31 
ARTICLE  97: PURIFIED WATER  ................................ ................................ ................................ .. 31 
ARTICLE  98: HIGHLY PURIFIED WAT ER ................................ ................................ ..................  31 
ARTICLE  99: WATER FOR INJECTION S ................................ ................................ .....................  31 
ARTICLE  100: OTHER GR ADES OF WATER  ................................ ................................ ..............  32 
ARTICLE  101: APPLICATION OF SPEC IFIC WATERS TO PROCE SSES AND DOSAGE 
FORMS  ................................ ................................ ................................ ................................ ..............  32 
ARTICLE  102: WATER PURIFICATION METHODS  ................................ ................................ .. 32 
ARTICLE  103: PRODUCTION OF DRINK ING-WATER  ................................ .............................  32  
  
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ARTICLE  104: PRODUCTION OF PURIF IED WATER  ................................ ...............................  32 
ARTICLE  105: PRODUCTION OF HIGHL Y PURIFIED WATER  ................................ ...............  32 
ARTICLE  106: PRODUCTION OF WATER  FOR INJECTIONS  ................................ ..................  32 
ARTICLE  107: WATER PURIFICATION,  STORAGE AND DISTRIB UTION SYSTEMS  ........  33 
ARTICLE  108: MATERIALS THAT COME  INTO CONTACT WITH S YSTEMS  .....................  33 
ARTICLE  109: SYSTEM SANITIZATION  AND BIOBURDEN CONTR OL ...............................  33 
ARTICLE  110: STORAGE VESSEL REQU IREMENTS  ................................ ...............................  33 
ARTICLE  111: WATER DISTRIBUTION PIPEWORK  ................................ ................................ . 33 
ARTICLE  112: START -UP AND COMMIS SIONING OF WATER SYS TEMS ...........................  33 
ARTICLE  113: QUALIFICATION OF A WATER SYSTEM  ................................ ........................  34 
ARTICLE  114: PERFORMANCE QUALIFI CATION: PHASE I ................................ ...................  34 
ARTICLE  115: PERFORMANCE QUALIFI CATION: PHASE 2  ................................ ..................  34 
ARTICLE  116: PERFORMANCE QUALIFI CATION: PHASE 3  ................................ ..................  34 
ARTIC LE 117: CONTINUOUS SYSTEM M ONITORING  ................................ ............................  34 
ARTICLE  118: MAINTENANCE OF WATE R SYSTEMS  ................................ ............................  35 
ARTICLE  119: SYSTEM REVIEWS  ................................ ................................ ...............................  35 
CHAPTER XVIII: HEATI NG, VENTILATION, AND  AIR-CONDITIONING SY STEMS FOR 
NON -STERILE PHARMACE UTICAL DOSAGE FORMS  ................................ ............................  35 
ARTICLE  120: HEAT ING, VENTILATION, AN D AIR -CONDITIONING S YSTEM  .................  35 
ARTICLE  121: PREVENTION OF CONTAM INATION AND CROSS -CONTAMINATION  .... 35 
ARTICLE  122: TEMPERATURE, RELATI VE HUMIDITY AND VENT ILATION  ....................  35 
CHAPTER XIX: QUALITY  RISK MANAGEMENT  ................................ ................................ ..... 35 
ARTICLE  123: QUALITY RISK MANAGE MENT  ................................ ................................ ........  35 
ARTICLE  124: DUTI ES AND ABILITY OF TH E PERSONNEL  ................................ .................  36 
ARTICLE  125: RISK ASSESSMENT OF THE PRODUCT  ................................ ...........................  36 
ARTICLE  126: ASSESSMENT OF PRODU CTS ................................ ................................ ............  36 
ARTICLE  127: MANUFACTURER TO CON DUCT RISK REVIEW AND  KEEP RECORDS  ... 36 
ARTICLE  128: VERIFICATION OF QUA LITY RISK MANAGEMENT  PROCESS AND 
METHODOLOGIES  ................................ ................................ ................................ .........................  37 
ARTICLE 129: RISK COMMUNICATION AND DOCUMENTATION ................................ ....... 37 
ARTICLE  130: MITIGATION PLANS  ................................ ................................ ............................  37 
ARTICLE  131: TRAINING AND EDUCAT ION ................................ ................................ ............  37 
ARTICLE  132: RESPONSIBILITIES OF  PHARMACEUTICAL MANU FACTURER  ................  37 
ARTICLE  133: COMPLAINT HANDLING AND INVESTIGATION  ................................ ..........  38 
ARTICLE  134: DUTY OF INSPECTORS  ................................ ................................ .......................  38 
CHAPTER XX: ACTIVE P HARMACEUTICAL INGRED IENTS  ................................ ................  38 
ARTICLE 135 : ACTIVE PHARMACEUTIC AL INGREDIENTS  ................................ .................  38 
CHAPTER XXI: WASTE M ANAGEMENT FOR MEDICI NAL PRODUCT MANUFACT URERS 
AND INSPECTION  ................................ ................................ ................................ ..........................  39 
ARTICLE 136: HAZARDO US WASTE  ................................ ................................ ..........................  39 
ARTICLE 137: NON -HAZ ARDOUS PHARMACEUTICA L WASTE  ................................ ..........  39 
CHAPTER XXII: CONDUC TING INSPECTIONS ................................ ................................ .........  39 
ARTICLE 138: APPLICA TION FOR GMP INSPECT IONS  ................................ ..........................  39  
  
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ARTICLE 1 39: APPOINTMENT OF I NSPECTORS  ................................ ................................ ...... 40 
ARTICLE 140: CONFLIC T OF INTEREST  ................................ ................................ ....................  40 
ARTICLE 141: POWERS OF INSPECTORS  ................................ ................................ ..................  40 
ARTICLE 142: INSPECT IONS  ................................ ................................ ................................ ........  41 
ARTICLE 143: ESTABLI SHMENT OF A SCIENTIF IC AND ADVISORY COMM ITTEE  ........  41 
ARTICLE 144: JOINT I NSPECTION  ................................ ................................ ..............................  41 
CHAPTER XXIII: FINAL  PROVIS IONS  ................................ ................................ ........................  41 
ARTICLE 145: WARNING S, SUSPENSIONS, AND REVOCATIONS  ................................ ....... 41 
ARTICLE 146: RESTORA TION OF A SUSPENDED OR REVOKED GMP CERTI FICATE ..... 42 
ARTICLE 147: APPEALS  ................................ ................................ ................................ ................  42 
ARTICLE 148: ADMINIS TRATIVE SANCTIONS  ................................ ................................ ........  43 
ARTICLE 149: PUBLICA TION OF GMP -COMPLIAN T FACILITIES  ................................ ........  44 
ARTICLE 150: COMMENC EMENT  ................................ ................................ ...............................  44 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
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CHAPTER ONE: GENERAL PROVISIONS  
 
Article One:  Purpose of these Regulations  
 
These regulations govern Good Manufacturing Practices herein after abbreviated as (GMP) of 
Medical Products.  
 
Article 2 : Citation  
 
These regulations may be cited as the “Regulations FDISM/FDIC/TRG/005,  Governing Good 
Manufacturing Practices of Medical Products.”  
 
Article 3:  Scope  
 
These regulations sha ll apply to GMP inspections of active pharmaceutical ingredients and finished 
pharmaceutical products sites that manufacture, import, export, distribute, store, sell , and that are 
used within and outside Rwanda for medical products.  
 
Article 4:  Definitions  
 
In these regulations, unless the context otherwise requires, the following terms are defined as follows:  
 
“Authority”  means the Rwanda Food and Drugs Authority or its acron ym “Rwanda FDA”, 
established by  Law N° 003/2018 of 09/02/2018.  
 
“Authorization”  means the license to manufacture medical products  
 
“Authorized Person” means an  individual; who possesses a recognized academic degree, has 
extensive knowledge, training and experience, and successfully demonstrated his/her ability to solve 
or resolve problems relating to the subject matter.  
 
“Applicant”  means any legal or natural person, established within or outside Rwanda, seeking to 
obtain or having obtained the license to manufacture medical products;  
 
“Active substance starting material”  means any substance from which an active substance is 
manufact ured or extracted;  
 
“Active substance intermediate”  means a substance that is obtained during the production of an 
active substance and which is intended for further processing;  
 
“Active P harmaceutical Ingredient (API or Drug Substance) ” means a ny substance or mixture 
of substances intended to be used in the manufacture of a drug (medicinal) product and that, when 
used in the production of a drug, becomes an active ingredient of the drug product. Such substances  
  
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are intended to furnish pharmacolo gical activity or other direct effect in the diagnosis, cure, 
mitigation, treatment, or prevention of disease or to affect the structure and function of the body  
 
“Conflict of interest”  means any interest in any business related to medicines declared  or undeclared  
by the inspector that may affect or reasonably perceived to affect the quality or the result of his work 
or remediation;  
 
“Critical observation”  means an observation describing a situation that will most likely result in a 
non-compliant prod uct or a  situation that may result in  immediate or latent health risk and any 
observation that involves fraud, misrepresentation , or falsification of products or data;  
 
“Finished pharmaceutical product (FPP)”  represents a pharmaceutical product after final  release 
(manufacturing control release, quality control release, packaging control release).  
 
“Good Manufacturing Practice inspector”  is an inspector appointed by the Rwanda FDA who 
possesses qualification s and experience in pharmaceutical  manufacturing, quality control, and quality 
assurance to conduct an inspection or assessment to verify GMP compliance of a manufacturing site 
on behalf of Rwanda FDA.  
 
“Manufacture”  means all operations of purchase of materials and products, production, p ackaging, 
quality control, release, storage, shipment of finished products, and the related controls;  
 
“Manufacturer”  means a company that carries out at least one step of manufacture;  
 
“Manufacturing process”  means the transformation of starting materials  into finished products such 
as drug substances or pharmaceutical dosage forms through a single operation or a sequence of 
operations involving installations, personnel, documentation , and environment;  
 
“Medical product”  includes human and veterinary drug,  human and animal vaccines and other 
biological prod ucts used in clinical as drug, herbal medicines and human and veterinary medical 
devices . 
 
“Minister”  means the “Person” a physical or legal entity  responsible for health;  
 
“Pharmaceutical product”  means any substance capable of preventing, treating human or animal 
diseases and any other substance intended for administration to a human being or an animal to 
diagnose diseases, restore, correct or carry out modification of organic or mental functions.  It also 
means products used in disinfecting premises where food and drugs are manufactured, prepared , or 
stored, cleaning hospitals, equipment , and farm houses;  
 
“Product quality review”  means regular, periodic , or rolling quality reviews of all medicinal 
products, including export -only products, conducted to verify  the consistency of the existing process,  
  
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the appropriateness of current specifications for both starting materials and finished product to 
highlight any trends and to identify product and proces s improvements.  
 
“Raw material”  means any substance, reagent , or solvent which is intended for use in the production 
of an active substance and from which the active substance is not directly manufactured or extracted.  
 
“Recall”  means an action taken by the manufacturer to remove  a medical  product from the market 
or to retrieve any such product from any person to whom it has been supplied, because the product 
may be hazardous to health; fail to conform to any claim made by its ma nufacturer relating to its 
quality, safety or efficacy; or not meet the requirements under these Regulations;  
 
“Validation”  means the establishment of documented and objective evidence that the p articular 
requirements for specific intended use can be consistently fulfilled . 
 
“WHO Listed Authority” means a regulatory authority which is:  
1. A member of the International Council for Harmonisation  of Technical Requirements for 
Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and 
Drug Administration and the Ministry of Health, Labour and Welfare of Japan also 
represented by the Pharmaceuticals and Medical Devices Agenc y (as before 23 October 
2015); or  
2. An ICH observer, being the European Free Trade Association, as represented by 
Swissmedic, and Health Canada (as before 23 October 2015); or  
3. A regulatory authority associated with an ICH member through a legally -binding, mu tual 
recognition agreement, including Australia, Iceland, Liechtenstein and Norway (as before 
23 October 2015). ” 
 
CHAPTER II:  GOOD MANUFACTURING PRACTICE INSPECTION  
 
Article 5: Obligation to obtain GMP certificate  
 
Any premise  related to the manufacture of medical products  must possess  a valid GMP certificate 
issued by the Authority  
No person or entity shall manufacture medical products without prior authorization from the 
Authority.  
 
The GMP certificate for premises used for c arrying out activities under Paragraph 1 of this article of 
this Regulation is granted by Authority . The requirements to obtain a GMP certificate are detailed in 
the relevant guidelines.  
The Authority shall conduct  inspection for confirmation of the compli ance to this Regulation and 
relevant guidelines.  A GMP certificate shall not be granted where the Authority finds the applicant 
not complying with the requirements prescribed in these regulations and relevant regulatory 
documents.  
  
  
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Article 6: Application for GMP  
 
A person who intends to undergo a GMP  inspection shall apply to the Director General of Rwanda 
FDA by submitting a set of required documents: the requirements are detailed in the relevant 
guidelines.  
 
Notwithstanding the provisions of paragraph one of this article, the inspection shall not be conducted 
at a facility that has not sub mitted applications for product  registration.  
 
ARTICLE 7: LANGUAGE  
 
All applications and supporting documents shall be made in English, French , or Kinyarwanda. Where 
some documents are submitted in a language different from English, French , or Kinyarwanda, the 
applicant shall submit translated copies  from approved translators  to expedite the review process.  
 
ARTICLE 8: AUTHENTICITY OF DOCU MENTS  
 
Any document submitted to the Authority shall be authentic when approved by the applicant or by 
the authorized person.  
The Authority may reject an application for GMP inspection of a medical product if it is satisfied 
that the submitted documents are not a uthentic or the integrity of data is questionable.  
 
ARTICLE 9: SAFE CUSTODY AND CON FIDENTIALITY OF INFO RMATION  
 
The Authority ensure s safe custod y of information related to GMP applications of manufacturing 
sites submitted by applicants. All information submitted shall be treated confidential ly and shall not 
be disclosed to any third party without the written consent of the applicant.  
 
ARTICLE 10: ASSESSMENT OF GMP APPLICATIONS  
 
The Authority shall, upon being satisfied by the application, conduct  an assessment to verify the 
compliance with GMP  requirements.  
1⁰ The Authority may, during the assessment of the dossier, require the applicant to submit 
additional documents, information, data , or clarification to support the application for GMP 
inspection.  
2⁰ Where the Authority requires additional documents, information, and data and or clarification 
pursuant to paragraph 1o of this Article, the processing of the application shall not proceed until 
the applicant submits  the additional submission.  
3⁰ Where the ap plicant fails to submit requested information according to paragraph 2o of this 
Article, within a period of ninety (90) days from the date of request, the application shall be 
considered withdrawn and a new application shall be required.   
  
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4⁰ Pursuant to the re quirements of paragraph 3o of this Article, the applicant may by giving 
reasons in writing request for an extension of time for submission of additional documents, 
information, data  and or clarification requested by the Authority.  
5⁰ If the applicant fails to provide satisfactory responses to the requested information according 
to paragraph 2o of this Article for the fourth time, the application shall be withdrawn and a new 
application shall be required.  
6⁰ An application withdrawn pursu ant to paragraph 3o and an application rejected pursuant to 
paragraph 5o of this Article shall only be considered for GMP inspection upon submission of a 
new application as per the requirements of these Regulations.  
 
Article 11: Reliance and Recognition  
 
The Authority may rely on regulatory decisions from regional, international , and WHO Listed 
Authority on decisions with regards to GMP inspection compliance when it deems necessary for 
facilities prequalified by WHO and those inspected and approved by coun tries or agencies with 
mutual recognition or cooperation agreements or partnerships  with Rwanda.  
The criteria for applicants to be considered for reliance and recognition shall be detailed in the 
Relevant guidelines.  
 
Article 12: Desk review  
 
After receipt of a duly filled GMP application, the Authority may conduct an assessment of the 
application through  a desk assessment review of the documents. Dossiers for desk assessments are 
conducted at the  discretion of the Authority. GMP applicants to be considered for GMP desk review 
shall have been subjected to a first inspection before being considered for desk assessment review 
unless otherwise determined by the Authority.  
The criteria for eligibility of sites for desk review are  detailed in the relevant guidelines  
 
Article 13: Virtual Inspections  
 
Upon receipt of a duly filled application, the Authority may conduct a voluntary virtual interactive 
inspection of facilities where medical products are manufactured, processed , or packed. This type of 
inspection is used when the Authority declares a case of force majeure on physical inspections.  
Facilities for virtual interactive inspections are conducted at the  discretion of the Authority and the 
criteria for the  selection of applicants shall be described in the relevant guidelines.  
  
Article 14: Temporary waivers of onsite inspection during emergency states  
 
Manufacturers who have applied for new and renewal of  GMP inspection but do not meet the criteria 
for desk review or virtual inspection shall form the short -term basis for decision making in the course 
of emergency s ituation.  
Criteria for applicants to be considered for temporary waivers will be as described in the relevant 
guidelines.   
  
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Article 15: Certificate and Validity  
 
Upon fulfilling the requirements, the Authority shall issue a Certificate of Good Manufacturing 
Practice. The certificate shall be valid for a period of three (3) years for both foreign and domestic 
sites.  
Any critical changes to the information contained in the GMP certification circumstances , shall be 
notified to the Authority within a period of fi fteen  (15) working days.  
 
CHAPTER III:  QUALITY MANAGEMENT PRINCIPLES  
 
Article 1 6: Quality Assurance System  
 
A manufacturer shall establish, document , and implement an effective system for managing the 
quality of those substances during the manufacturing operations performed by them The system shall 
provide for the active participation of the management and manufacturing personnel.  
A manufacturing facility shall have a comprehensively designed and correctly implemented Quality 
Assurance System. The Quality Assurance (QA) system should be appropriate for medical product 
manufacturing.  
 
Article 1 7: Good Manufacturing Practice s 
 
Good Manufacturing Practice as part of quality assurance shall ensure that the products are 
consistently produced and controlled to meet the quality standards appropriate to their intended use 
and requirements of marketing authorization and product specificatio n. 
Good Manufacturing Practice rules shall direct to diminish risks due to cross -contamination or mix -
ups that cannot be completely prevented through the testing of final products.  
 
Article 1 8: Quality control  
 
Every pharmaceutical manuf acturing facility shall have a quality c ontrol unit which is independent 
of the  production units  and any other department. The quality control laboratory shall be under the 
authority of a person with appropriate qualification s and experience.  
 
Article  19: Quality control Requirements  
 
Manufacturers shall comply w ith the basic requirements for q uality control as detailed in the relevant 
GMP guidelines.  
 
Article 20: Product quality review  
 
The m anufacturing facility shall carry out a regular, periodic , or rolling quality review of all medical 
products including export -only products. The review shall be conducted and documented annually, 
taking into account previous reviews , and shall include information in the relevant guidelines .  
  
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A Manufacturer shall evaluate  results and assess whether corrective and preventive action or any 
revalidation is required . 
Corrective and preventive action shall be documented and shall be performed  in a timely and 
effective manner.  
Where the market authorization holder is different from the manufacturer, there shall be a technical 
agreement in place between the various parties with their responsibilities for producing the quality 
review. The authorized person responsible for the final batch ce rtification, together with the 
marketing authorization holder, shall ensure that the quality review is performed promptly  and is 
accurate.  
 
Article 21: Quality risk management  
 
A manufacturer shall have a systematic process for assessment, control, communication , and review 
of risk to the quality of  a medical  product. The system shall ensure evaluation of the risk based on 
scientific knowledge and experience with the process to protect the patient. The formality and 
documentation of the quality risk management process shall be based on risk level.  
 
Article 22: Sanitation and Hygiene  
 
Every step of medical product  manufacturing shall be carried out with a high-level of sanitation and 
hygiene . The relevant requirements for manufacturers with regards to sanitation and hygiene are 
detailed in the relevant guidelines.  
 
CHAPTER IV : PERSONNEL  
 
Article 2 3: Principles governing personnel  
 
The manufacturer shall have an approved organization al chart and ensure an adequate number of 
personnel having the necessary qualifications acquired through education, training , or practical 
experience to carry out and supervise the manufacturing of medical products.  
All personnel shall be aware of the princ iples of good manufacturing practice that affect them and  
receive  initial and continuing training, including hygiene  
The responsible  staff shall  have  their duties  recorded  in written  descriptions, well understood , and 
have adequate  authority  to carry out their responsibilities.  
 
Article 2 4: Key Personnel  
 
A manufacturing facility shall  at least have the following key personnel:  
1⁰ Head of production;  
2⁰ Head of quality assurance;  
3⁰ Head of quality control; and  
4⁰ Authorized person.  
  
  
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A manufacturer shall formally notify the Authority of the name of qualified and authorized persons 
appointed by the manufacturer and the specific functions which have been delegated to such persons.  
Key posts shall be  occupied by full -time personnel.  
 
Article 25: Academic qualifications of key personnel  
 
The necessary  qualifications of the key personnel will be detailed in the relevant guidelines by the 
Authority.  
 
Article 2 6: Training  
 
A manufacturer shall provide training as per the written program for all the personnel whose duties 
take them into production areas or into  quality  control laboratories inclu ding the technical, 
maintenance  and cleaning personnel  and any other personnel whose activities could affect the quality 
of the product.  
Every  staff shall receive initial and continuous training appropriate to the duties assigned to them. 
Records of these training shall be kept and retrieved as per the approved training program.  
Personnel working in areas where contamination is hazardous such as  clean areas or areas where 
highly active, toxic, infectious, or sensitizing materials are handled shall be given specific training.  
 
Article 2 7: Personal hygiene  
 
Every employee  whether temporary or full -time employees or non -employees such as contractors' 
employees, visitors, senior managers , and inspectors  shall practice good sanitation and hygiene in 
the manufacturing area.  The relevant requirements for sanitation and hygiene will be prescribed in 
the relevant guidelines.  
 
CHAPTER V : PREMISES  
 
Article 28: Layout and design  
 
Premises shall be located, designed, constructed, adapted, and maintained to suit the operations 
carried out and to facilitate cleaning and maintenance, provide maximum protection against the entry 
of insects, birds , or any other animals , minimize the risk of errors and contamination having regard 
to the type and stage of m anufacturing which the building and facility  are used for.  
 
Article 29: Production area  
 
The p roduction area shall be designed to minimize contamination. Dedicated, separate , and self -
contained facilit ies shall be available for the production of particular  product s, such as penicillin, 
cephalosporin , and other highly sensitizing materials and biological preparations like live 
microorganisms, hormones, cytotoxic substances, highly active medicinal products, and non -
medicinal products.   
  
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The manufacture of technical poisons, such as pesticides and herbici des, shall not be allowed on 
premises used for the manufacture of medical product s. 
Production shall take place in areas connected in a logical order corresponding to the sequence of the 
operations, materials flow, personnel movement , and the requisite cle anliness levels.  
 
Article 30: Storage area  
 
Storage areas shall be of sufficient capacity to ensure good storage conditions  and allow orderly 
storage of various categories of materials and products; starting and packaging materials, 
intermediates, bulk , and finished products, products in quarantine, released, rejected, returned, or 
recalled products. and that these products are maintained within acceptable temperature limits  
Highly active materials, narcotics, other dangerous drugs, and substances presen ting special risks of 
abuse, fire, or explosion shall be stored in safe and secure areas.  
Printed packaging materials are critical to the conformity of medical product s for their labeling, and 
special attention shall be paid to sampling and safe and secure  storage of these materials.  
 
Article 31: Weighing areas  
 
Weighing of starting materials and the estimation of yield by weighing shall be carried out in separate 
weighing areas designed for that purpose with provisions for control of contamination.  
 
Article 3 2: Quality control areas  
 
Quality control laboratories shall be separated from production areas and areas where biological, 
microbiological, or radioisotope test methods are employed shall be separated from each other.  
Control laboratories shall be designed suitable for the operations carried out, with sufficient space to 
avoid mix -ups and cross -contamination; and with adequate and suitable storage space for samples, 
reference standards, if necessary, with cooling, and records.  
Laboratories and production areas shall have a separate air supply. Separate air -handling units and 
other provisions are needed for biological, microbiological, and radioisotope laboratories.  
A separate room may be needed for instruments to protect them against electrical interference, 
vibration, contact with excessive moisture, and other external factors, or where it is necessary to 
isolate the instruments.  
 
Article 3 3: Ancillary areas  
 
Rest and refreshment rooms shall be separate from other areas. Facilities for changing,  storing 
clothes, washing , and toilet purposes shall be easily accessible and appropriate for the number of 
users. Toilets shall not communicate directly with production or storage areas.  
Maintenance workshops shall be separated from production areas and in case, parts and tools are 
stored in the production area they shall be kept in rooms or lockers reserved for that use.  
Animal houses shall be well isolated from other areas, with separate entrance animal access and air -
handling facilities.   
  
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CHAPTER VI : EQ UIPMENT  
 
Article 34: Design and location of manufacturing equipment  
 
The layout, design , and location of equipment shall aim to minimize the risk of errors and permit 
effective cleaning and maintenance and, where appropriate sanitization to avoid cross -contamination, 
build -up of dust or dirt, and any adverse effect on the quality of products.  
 
Article 35: Manufacturing equipment  
 
Production equipment shall not present any hazard to the products and all parts of the production  
equipment that come into contact with the product must not be reactive, additive, or absorptive to an  
extent  that would  affect the  quality of the product.  
The manufacturer shall establish written procedures for the cleaning of equipment and the subsequent 
verification of its suitability for use in the manufacturing process.  
Control, weighing, measuring, monitoring , and tes ting equipment that is critical for assuring the 
quality of the starting materials, intermediates , and finished product shall be calibrated following  
written procedures and an established schedule.  
 
CHAPTER VII : DOCUMENTATION  
 
Article 36: Good documentation practice  
 
The ma nufacturer shall establish and maintain a documentation system and written procedures 
covering the manufacturing process. All documents concerning the manufacturing process shall be 
prepared, reviewed, approved , and distributed following  written procedures.  
A manufacturer shall have a good documentation practice as an essential part of the quality assurance 
system which is related to all aspects of GMP including  The requirements of Good Documentation 
Practice will be detailed in the relevant guidelines  
All quality -related activities carried out during the manufacturing process shall be recorded at the 
time they are performed. Any deviation from the written procedures referred to in Article 7(1) shall 
be documen ted and explained. Deviations affecting the quality of the active substance or preventing 
the active substance from meeting the specifications referred to in Article 12(1) shall be investigated, 
and the investigation and its conclusions shall be documented . 
 
Article  37: Prepared document  
 
A manufacturer shall design and make use of the documents which are free from errors and available 
in writing. The issuance, revision, replacement , and withdrawal of documents related to the 
manufacturing process shall be controlled, and records of their revision, replacement , and withdrawal 
shall be kept.  
 
  
  
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Article  38: Labels  
 
A manufacturer shall ensure labels that are applied to containers, equipment, or premises are clear, 
unambiguous, and in the company’s agreed format. Color  coding to indicate status for quarantined, 
accepted, rejected, or cleaned shall be used.  
 
CHAPTER VIII: PRODUCTION  
 
Article 39: Production Operation  
 
Every manufacturer shall have production operations that follow clearly defined procedures 
following  manufacturing and marketing authorizations, to obtain  products of the requisite quality.   
Production operations shall be subject to controls to monitor and adjust the production process or 
verify that the active substance conforms to the specifications of quality pursuant to Article 12(1). 
Production operations that are critical to ensure that the active substance or finished medical product  
meets the quality specifications referred to in Article 12(1) shall be carried out under the visual 
supervision of qualified personnel or subjected to an equivalent control.  
Weighing and measuring of active pharmaceutical ingredients  and starting materials shall be accurate 
and shall be conducted in a manner that does not affect their suitability for use.  
 
Article  40: Handling Products  
 
A manufacturer shall ensure that all productions are performed and supervised by competent people. 
A manufacturer shall not handle materials and products without following written procedures or 
instructions. A person shall not carry out operations on different products simultaneously or 
consecutively in the same room or a rea unless there is no risk of mix -up or cross -contamination.  
A manufacturer shall at all times during processing, ensure all materials, bulk containers, major items 
of equipment, and where appropriate the rooms and packaging lines used are labelled or oth erwise 
identified with an indication of the product or material being processed, its strength, batch number 
and an indication of the production stage.  
A person shall not access production premises without being authorized.  
A person shall not produce non -medicinal products in areas or equipment destined for the production 
of medical product s. 
Every manufacturer shall perform in -process controls within the production area without carrying 
any risk for the quality of the product.  
 
Article  41: Cross contamination and bacterial contamination in Production  
 
The manufacturer shall take special precautions when dry materials and products are used in 
production to prevent the generation and dissemination of dust.  
A manufacturer shall make a provision for proper air control such as supply and extraction of air of 
suitable quality.   
  
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Manufacturing operations shall  be conducted in a manner that prevents raw materials, active 
substance starting materials, active substance intermediates , and active substances fro m being 
contaminated by other materials and bacterial  
Notwithstanding the provision of (Article 41) above, all manufacturers shall ensure materials used 
are of a suitable grade to minimize health risks;  
 
CHAPTER IX: GOOD PRACTICES IN QUALITY CONTROL  
 
Article  42: Quality  
 
A manufacturer cannot release materials for use or products for sale or supply  until their quality has 
been judged satisfactory.  
 
Article  43: Department and Laboratory  
 
Every manufacturer shall have a separate Quality Control department separated from production and 
other departments and shall be under a designated person with appropriate qualifications and 
experience.  
All laboratory operations shall be carried out follow ing written procedures and, where necessary, 
recorded.  
 
Article  44: Documentation  
 
Quality control documents shall consist of the following important parts: specifications, sampling 
procedures, testing procedures , and records including analytical worksheets and laboratory 
notebooks, analytical reports and certificates, data from environmental monitoring, where required, 
validation records of test methods, where applicable , and procedures and record for calibration of 
instruments and maintenance of equipment.  
 
Article  45: Sampling  
 
The sample taking shall be done following  approved written procedures  
Reference samples shall be representative of the batch of materials or products from which they are 
taken and each batch of finished products shall be retained till one year after the expiry date.  
A manufacturer shall keep finished products in their final packaging and stored under the 
recommended conditions.  
Samples of starting materials other than solvents, gases , and water shall be retained for at least one 
year beyond the expiry date of the product if their stability allows.  
Reference samples of materials and products shall be of a size sufficient to permit at least two full 
examinations.  
 
  
  
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Article  46: Starting Materials and Intermediate products  
 
All tests shall follow the instructions given in the relevant written test procedure for each material or 
product and the results shall be checked by the supervisor before the material or product is released 
or rejected.  
 
Article  47: Test requirements  
 
A person shall not release starting or packaging materials unless ensured by the Head of quality 
control that the materials have been tested for conformity with specifications for identity, strength, 
purity, and other quality parameters.  
 
Article  48: In-process control  
 
In-process control records shall be maintained and form a part of the batch records as prescribed in 
these regulations.  
 
Article  49: Finished products  
 
For each batch of drug product, there shall be an appropriate laboratory determination of satisfactory 
conformity to its finished product specification before  release.  
A manufacturer shall reject products failing to meet the established specifications or any other 
relevant quality criteria.  
A manufacturer  may perform  reprocessing  only if the product  meets  all specifications  and other  quality  
criteria  before  its acceptance  and release.  
 
Article 50: Batch record review  
 
Every manufacturer shall review production and control records and any divergence or failure of a 
batch to meet its specifications shall be thoroughly investigated and recorded.  
 
Article  51: Stability Studies  
 
The manufacturer shall monitor the stability of the medicinal product according to a  continuous 
appropriate program.  
A manufacturer shall perform stability studies on reconstituted product s during product development 
and if necessary may be monitored on an ongoing basis.  
A manufacturer shall describe the ongoing stability pr ogram in a written protocol.  
 
Article  52: Reagents and Culture media  
 
A manufacturer shall record upon receipt or preparation of all reagents and culture media.   
  
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Reagents made up in the laboratory shall be prepared and appropriately labelled according to written  
procedures.  
Both positive and negative controls shall be applied to verify the suitability of culture media and the  
size of the  inoculum  used in positive  controls shall be  appropriate to the  sensitivity required.  
 
Article  53: Reference Standards  
 
Every manufacturer shall ensure the availability of reference standards in the form of official 
reference standards such as the recognized Pharmacopeia.  
All in -house reference standards shall be standardized against an official reference standard/  
Referen ce standards  prepared  by the producer  shall  be tested,  released,  and then stored  in the same  
way as official  standards  kept under  the responsibility of  a designated  person in  a secure  area and 
shall be properly labelled.  
 
CHAPTER X: CONTRACT  
 
Article  54: Contractual Arrangements  
 
A manufacturing operation or an operation linked thereto which is to be carried out on behalf of the 
manufacturer of the me dical product by another party ‘the contract manufacturer’  shall be the subject 
of a written contract.  The written contract shall establish the duties of each party and the contract 
must clearly state how the authorized person, in releasing each batch of product for sale or issuing 
the certificate of analysis, exercises the full responsibility.  
 
Article  55: Obligation of Parties to contract  
 
The contract shall clearly define the responsibilities of the contract manufacturer concerning  Good 
Manufacturing Practice s.  
The manufacturer of the  products shall control those  operations carried out by a contract 
manufacturer to comply with Good Manufacturing Practice s. 
 
Article  56: Essential requirements of the contract  
 
Manufacturing shall be undertaken by a manufacturer who holds a manufacturing authorization. The 
contract shall describe clearly who is responsible for purchasing, testing, and releasing materials and 
for undertaking production and quality controls, including in -process controls, and who has 
responsibility for sampling and analysis . 
A contract shall not pass to a third party any of the work entrusted without the prior evaluation and 
approval of the original parties. The contract shall refrain from any activity that may adversely affect 
the quality of the product manufactured and analyzed.  
 
  
  
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CHAPTER XI: COMPLAINTS HANDLING AND PRODUCT RECALL  
 
Article  57: Complaints handling  
 
Every manufacturer shall carefully review according to written procedures all complaints and other 
information concerning potentially defective products.  
A manufacturer shall take immediate corrective actions to address the root cause of the problem, and 
actions should be taken to prevent it from recurring and  shall regularly review complaints records.  
The Manufacturer shall inform the Authority if there is an action taken following possibly faulty 
manufacturing, product deterioration, or any other serious quality problems with a product without 
delay.  
 
Article  58: Product recall  
 
A manufacturer shall not sell, offer , or expose for sale any product subjected to recall.  
Every manufacturer shall appoint a person responsible for the execution and coordination of recalls 
who shall be also independent  of the  sales and marketing department.  
There shall be establi shed written procedures for the organization of any recall activity.  
Every manufacturer shall be capable of initiating promptly recall operations at least down to the level 
of a hospital or pharmacy or any authorized drug outlet.  
 
CHAPTER XII: SELF -INSPECTION, QUALITY AUDITS, SUPPLIER AUDITS , AND 
APPROVALS  
 
ARTICLE  59: SELF -INSPECTION  
 
A manufacturer shall have a documented procedure for self -inspection.  
 
Article  60: Items for self -inspection  
 
There shall be established a program for self-inspection to provide a minimum and uniform standard 
of Good Manufacturing Practice requirements.  
 
Article  61: Self-inspection team  
 
Management shall appoint a self -inspection team consisting of experts in their respective fields and 
familiar with Good Manufacturing Practice s. 
 
Article  62: Frequency of self -inspection  
 
The frequency at which self -inspections are conducted may depend on company requirements but 
shall preferably be at least once a year and described in the procedure.   
  
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Article  63: Self-inspection report  
 
A report shall be made after a self -inspection with inspection findings, evaluation, conclusion , and 
recommended corrective actions.  
 
Article  64: Follow -up action  
 
There shall be an effective follow -up program and the company management shall evaluate both the 
self-inspection report and the corrective actions as necessary.  
 
Article  65: Audits , and approval  
 
The person responsible for Quality Control together with other relevant departments shall have the 
responsibility of evaluating , and approving vendor s and suppliers that meet established specifications 
before being included in the approved supplier's list.  
 
CHAPTER XIII: MANUFACTURE OF STERILE MEDICINAL PRODUCTS  
 
Article  66: Sterile medicinal products  
 
A manufacturer of sterile products shall be subjected to special requirements to minimize risks of 
microbiological contamination, and particulate and pyrogenic contamination detailed in the relevant 
guidelines.  
A manufacturer shall strictly follow carefully established and validated methods of preparation and 
procedure.  
Only a minimum number of personnel required shall be present in clean areas and this is particularly 
important during aseptic processing.  
The manufacturing of sterile products shall be carried out in clean ar eas Clean areas for the 
manufacture of sterile products shall be classified into four clean grades according to the required 
characteristics of the environment as follows: Grade A, Grade B, Grade C , and D .  
The areas for operations such as blow, fill and sealing technologies,  terminally sterilized products , 
and aseptic preparation shall be monitored during operation in to control the particulate cleanliness 
of the various grades.  
 
Article  67: Isolator technology  
 
Isolators shall be introduced only after appropriate validation and take into account all critical factors 
of isolator technology.  Monitoring shall be carried out routinely.  
 
Article  68: Personnel  
 
Only a minimum number of personnel required shall be present in clean areas and this is particularly 
important during aseptic processing .  
  
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Article  69: Premises  
 
In clean areas,  sinks and drains should be prohibited in grade A and B areas used for aseptic 
manufacture , and in other areas , air brakes should be fitted between the machine or sink and the 
drains . 
Both airlock doors should not be opened simultaneously and an interlocking system or a visual or 
audible warning system should be operated to prevent the opening of more than one door  at a time . 
A filtered air supply shall maintain positive pressure and airflow relative to surrounding areas of a 
lower grade under all operational conditions and shall flush the area effectively.  
Adjacent rooms of different grades shall have a pressure di fferential of 10 -15 Pascal  guidance values . 
 
Article  70: Equipment  
 
All equipment such as sterilizers, air handling , and filtration systems, air vent and gas filters, water 
treatment, generation, storage , and distribution systems shall be subject to validation , and planned 
maintenance , and their return to use should be approved.  
Water for injections shall be produced, stored , and distributed in a manner that prevents microbial 
growth, for example by consta nt circulation at a temperature above 70°C.  
 
Article  71: Sanitation  
 
The sanitation of clean areas shall be done following  a written program and where disinfectants are 
used, more than one type shoul d be employed. Monitoring must  be undertaken regularly to detect the 
development of resistant strains.  
 
Article  72: Processing  
 
Preparations of microbiological origin shall not be made or filled in areas used for the processing of 
other medicinal product s. 
Vaccines of dead organisms o r bacterial extracts may be filled, after inactivation, in the same 
premises as other sterile medicinal products.  
Process simulation tests shall be performed at least twice a year per shift and process.  
The manufacturer should establish alert and action lim its and any contamination should be 
investigated.  
Water sources, water treatment equipment , and treated water shall be monitored regularly for 
chemical and biological contamination and, as appropriate, for endotoxins and records shall be 
maintained of the results of the monitoring and any action taken.  
Non-combustible gases shall be passed through microorganism retentive filters.  
The efficacy of any new procedure shall be validated and the validation verified at scheduled intervals 
based on performance hist ory or when any significant change is made in the process or equipment.  
 
  
  
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Article  73: Processing Sterilization  
 
All sterilization processes shall be validated and records should be kept and they should be approved 
as part of the batch release procedure. The requirements for each method of sterilization and sterility 
testing are detailed in the relevant guidelines.  
 
CHAPTER XIV: BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE  
 
Article  74: Biological medicinal products  
 
The manufacture of biological medicinal products shall involve certain specific considerations 
arising from the nature of the products and the processes. Control of biological medicinal products 
shall involve biological analytical techniques which have gre ater variability than physical -chemical 
determinations.  
In-process  controls shall take great importance in the manufacture of biological Medicinal products.  
 
Article  75: Personnel  
 
The manufacturing establishment and its personnel shall be under the authority of a person who has 
been trained in the techniques used in manufacturing biological substance s and who possesses the 
scientific knowledge upon which the manufacture of these products is based.  
 
Article  76: Premises and Equipment  
 
The design building and construction materials shall permit maintenance in a clean and sanitary 
condition free from insects and vermin.  
Facilities for animal care shall include isolation units for quarantine of incoming animals and 
provision for vermin -free food stor age. 
 
Article  77: Animal Quarters and Care Production  
 
The building shall be located, designed constructed, adapted , and maintained to suit the operations 
to be carried out therein.  
 
CHAPTER XV: VALIDATION  AND  QUALIFICATION  
 
Article  78: Validation  
 
A manufacturer shall identify validation work needed to prove control of the critical aspects of their 
operations.  
Manufacturers shall use a risk assessment approach to determine the scope and extent of validation.  
 
  
  
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Article  79: Validation activities  
 
Every manufacturer shall plan all validation activities a validation master plan or equivalent 
document.  
 
Article  80: Documentation  
 
A written protocol shall be established to specify how qualification and validation will be conducted.  
Any changes to the  plan as defined in the protocol shall be documented with appropriate justification. 
After completion of a satisfactory qualification, a formal release for the next step in qualification and 
validation shall be made as written authorization.  
 
Article 81: Design Qualification  
 
The first element of the validation of new facilities, systems , or equipment shall be design 
qualification. The compliance of the document with Good Manufacturing Practice shall be 
demonstrated and documented by the manufacturer.  
 
Article  82: Installation Qualification  
 
Installation qualification shall be performed on new or modified facilities, systems , and equipment.  
 
Article  83: Operational Qualification  
 
Operational qualifications shall follow installation qualification.  
 
Article  84: Performance Qualification  
 
Performance qualification shall follow successful completion of installation qualification and 
operating equipment.  
 
Article  85: Qualification of established facilities, systems , and equipment  
 
Evidence shall be available to support and verify the operating parameters and limits for the critical 
variables of the operating equipment. Calibration, cleaning, preventative maintenance, operating 
procedures , and operator training procedures and records shall be document ed. 
 
Article  86: Process validation  
 
Process validation shall be categorized as prospective validation, concurrent validation; and 
retrospective validation.  
Facilities, systems , and equipment to be used shall have been qualified and analytical testing methods 
shall be validated. Staff taking part in the validation work shall have been appropriately trained.  
  
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Facilities, systems, equipment and processes shall be periodically evaluat ed to verify that they are 
still operating validly.  
 
Article 87: Cleaning validation  
 
Cleaning validation shall be performed to confirm the effectiveness of a cleaning procedure.  
 
Article 88: Transport and delivery validation  
 
The manufacturer shall be responsible for qualification of all transportation or vehicles used in the 
transportation of medical products to ensure medical product safety and quality. The requirements 
for transport and delivery qualification are described i n the relevant guidelines.  
 
Article  89: Change control  
 
Written procedures shall be in place to describe the actions to be taken if a change is proposed.  
All changes that may affect product quality or reproducibility of the process shall be formally 
requested, documented , and accepted.  
The likely impact of the change of facilities, systems , and equipment on the product shall be 
evaluated, including risk analysis. The need for, and the extent of, requalification and revalidation 
shall be determined.  
 
Article  90: Revalidation  
 
Facilities, systems, equipment , and processes, including cleaning, shall be periodically evaluated to  
confirm that they remain valid, updated and maintained.  
 
CHAPTER XVI: DIGITALIZED SYSTEM  
 
Article  91: Computerized systems  
 
ln case computerized systems are used, there shall be no resultant decrease in product quality or 
quality assurance.  
 
Article  92: Validation  
 
Before a system using a computer is brought into use, the computer system shall be validated.  
 
Article  93: Handling of system  
 
A written detailed description of the system shall be produced including diagrams as appropriate and 
kept up to date.   
  
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The user of computerized software shall take all reasonable steps to ensure that it has been produced 
following  a system of quality assurance.  
Data shall only be entered or amended by  authorized persons.  There shall be a defined procedure for 
the issue, cancellation, and alteration of authorization to enter and amend data, including the changing 
of personal passwords.  
Data shall be secured by physical or electronic means against willful or accidental damage. Stored 
data shall be checked for accessibility, durability , and accuracy.  
 
CHAPTER XVII: WATER FOR PHARMACEUTICAL USE  
 
Article  94: Pharmaceutical water system  
 
Pharmaceutical water production, storage , and distribution systems shall be designed, installed, 
commissioned, validated , and maintained to ensure the reliable production of water of appropriate 
quality. The system shall not be operated beyond its designed capacity.  
 
Article  95: Water quality specifications  
 
Companies wishing to supply multiple markets shall set specifications that meet the strictest 
requirements from each of the relevant pharmacopeias.  
 
Article  96: Drinking water  
 
Drinking water shall be supplied under continuous positive pressure in a plumbing system free of 
any defects that could lead to contamination of any product.  
 
Article  97: Purified water  
 
Purified water shall be prepared from a potable water source as a minimum quality feed-water, should 
meet the pharmacopoeia specifications for chemical and microbiological purity, and should be 
protected from re -contamination and microbial proliferation.  
 
Article  98: Highly purified water  
 
Highly purified water shall be prepared from po rtable water as minimum quality feed  water. This 
grade of water shall meet the same quality standard as water for injections including the limit for 
endotoxins.  
 
Article  99: Water for injections  
 
Water for injections shall be prepared from potable water as minimum -quality feed  water.  
  
  
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Article  100: Other grades of water  
 
When a specific process requires a special non -pharmacopeia grade of water, they shall be specified 
and at least satisfy the pharmacopeia requirements of the grade of pharmaceutical water for the use 
required for the type of dosage form or process step.  
 
Article  101: Application of specific waters to processes and dosage forms  
 
The grade of water used shall take into account the nature and intended use of the intermediate or 
finished product and the stage in the manufacturing process at which the water is used.  
 
Article  102: Water purification methods  
 
The chosen water purification method, or sequence of purification steps, shall be appropriate to the 
application in question. Factors to consider when selecting the water treatment methods will be 
detailed in  the relevant guideline.  
 
Article  103: Production of drinking -water  
 
Typical processes employed at a user plant or by a water supply authority shall include:  
1⁰ Filtration;  
2⁰ Softening;  
3⁰ Disinfection or sanitization such as bi -sodium hypochlorite (chlorine) Injection;  
4⁰ Iron (ferrous) removal;  
5⁰ Precipitation; and  
6⁰ Reduction of specific inorganic /organic materials.  
 
Article  104: Production of purified water  
 
Any appropriate ly qualified purification technique or sequence of techniques shall be used to prepare 
purified water.  
 
Article  105: Production of highly purified water  
 
Any appropriate ly qualified purification technique or sequence of techniques shall be used t o prepare 
highly purified water where needed.  
 
Article  106: Production of water for injections  
 
Distillation shall be the preferred technique and it is considered a more robust technique based on 
phase change, and in some cases, high -temperature operation of the process equipment.  
 
The following shall be considered when designing a water purification system:   
  
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1⁰ The feed -water quality;  
2⁰ The required water quality specification;  
3⁰ The optimum generator size to avoid the over-frequent start/stop cycling;  
4⁰ Blow -down and dump functions; and  
5⁰ Cool -down venting to avoid contamination ingress.  
 
Article  107: Water purification, storage and distribution systems  
 
The water storage , and distribution shall work in conjunction with the purification plant to ensure 
consistent delivery of water to the user points, and to ensure optimum operation of the water 
purification equipment. The storage and distribution system shall be considered a key part of the 
whole system, and shall be designed to be fully integrated with the water purification components of 
the system.  
 
Article  108: Materials that come into contact with systems  
 
The materials that come into contact with water for pharmaceutical use, including pipework, valves , 
fittings, seals, diaphragms , and instruments, shall be selected as per relevant requirements as detailed 
in the guidelines.  
 
Article  109: System sanitization and bioburden control  
 
Water treatment equipment, storage and distribution systems used for purified water, highly purified 
water , and water for injection shall be provided with features to control the proliferation of 
microbiological organisms during normal use, as well as techniques for sanitizing or st erilizing the 
system after intervention for maintenance.  
 
Article  110: Storage vessel requirements  
 
The design and size of the vessel shall take into consideration the following elements; Capacity; and 
contamination control considerations.  
 
Article  111: Water distribution pipework  
 
The distribution of purified water, highly purified water , and water for injection shall be 
accomplished using a continuously circulating pipework loop. The p roliferation of contaminants 
within the storage tank and distribution loop shall be controlled. Filtration shall not be used in 
distribution loops or at take -off user points to control bio -contamination.  
 
Article  112: Start -up and commissioning of water systems  
 
The commissioning work shall include setting to work, system setup, and controls loop tuning and 
recording of all system performance parameters. If it is intended to use or refer to commissioning  
  
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data within the validation work, then the quality of the com missioning work and associated data and 
documentation shall be commensurate with the validation plan requirements.  
 
Article  113: Qualification of a water system  
 
Purified water, highly purified water , and water for injection systems are all considered to have a 
direct impact on quality critical systems and shall be qualified. The qualification shall follow the 
validation convention of design review or design qualification, installation qualification, o perational 
qualification , and performance qualification.  
A three -phase approach shall be used to satisfy the objective of proving the reliability and robustness 
of the system in service over an extended period.  
 
Article  114: Performance Qualification: Phase I  
 
A test period of 2 to 4 weeks shall be spent monitoring the system intensively. During this period the 
system shall be operated continuously without failure or performance deviation.  
 
Article  115: Performance Qualification: Phase 2  
 
A further test period of 2 to 4 weeks shall be spent carrying out further intensive monitoring while 
deploying all the refined SOPs after the satisfactory completion of phase I. The sampling scheme 
shall be generally the same as in phase I; water can be used for manufacturing purposes during this 
phase.  
 
Article  116: Performance Qualification: Phase 3  
 
Phase 3 typically shall run for 1 year after the satisfactory completion of phase 2.  
Water can be used for manufacturing purposes during this phase which has the following objectives 
and features:  
1⁰ Demonstrate extended reliable performance;  
2⁰ Ensure that seasonal variations are evaluated; and  
3⁰ The sample locations, sampling frequencies , and tests shall be reduced to the normal routine 
pattern based on established procedures proven during phases 1 and 2.  
 
Article  117: Continuous system monitoring  
 
After completion of phase 3 of the qualification program for the water for pharmaceutical use system, 
a system review shall be undertaken. A routine monitoring plan shall be established based on the 
results of phase 3.  
 
 
  
  
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Article  118: Maintenance of water systems  
 
Water for Pharmaceutical use systems shall be maintained following  a controlled, documented 
maintenance program  
 
Article  119: System reviews  
 
Water for Pharmaceutical use systems shall be reviewed at appropriate regular intervals. The review 
team shall comprise representatives from engineering, Quality Assurance, operations , and 
maintenance.  
 
CHAPTER XVIII: HEATING, VENTILATION , AND AIR -CONDITIONING SYSTEMS 
FOR NON -STERILE PHARMACEUTICAL DOSAGE FORMS  
 
Article  120: Heating, ventilation , and air -conditioning system  
 
Every pharmaceutical dosage form shall be manufactured under an installed and retained heating, 
ventilation , and air -conditioning system to ensure that the quality of medical product s is not 
compromised  
The system shall be well -designed to provide comfortable conditions for operators.  
 
Article  121: Prevention of contamination and cross -contamination  
 
There shall be prevention of contamination and cross -contamination as an essential design to be 
inspected by the Authority within the system of heating, ventilation and air -conditioning of the 
Manufacturing site.  
The design of the heating, ventilation and air -conditioning system shall be shown in the drawings of 
the pharmaceutical manufacturing plant.  
 
Article  122: Temperature, relative humidity and ventilation  
 
The system temperature, relative humidity , and ventilation shall not adversely affect the quality of 
medical product s during their manufacture and storage or the accurate functioning of equipment.  
 
CHAPTER XIX: QUALITY RISK MANAGEMENT  
 
Article  123: Quality Risk Management  
 
The Quality Risk Management methodology shall:  
1⁰ Be dynamic, iterative , and responsive to change; and  
2⁰ Systematically analyze products and processes to ensure the best scientific rationale is in place 
to improve the ability to succe ed;  
  
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3⁰ Identify important knowledge gaps associ ated with processes that need to be understood to 
properly identify risks and provide a communication process that will best interface with all 
relevant parties involved;  
Facilitate the transfer of process knowledge and product development history to ease product 
progression along the life -cycle and to supplement already available knowledge about the product;  
 
Article  124: Duties and ability of the personnel  
 
A manufacturer shall keep personnel with specific knowledge and expertise available at the 
manufacturing site to ensure effective planning and completion of Quality Risk Management 
activities:  
 
Article  125: Risk assessment of the product  
 
At any time when the risk assessment of the product is conducted, the manufacturer shall need to 
determine the safety and efficacy of  the product in addition to its quality concerns and where 
applicable; all the risks that may be reasonably expected to occur in the activity under evaluation 
shall be listed for verification by inspectors.  
 
Article  126: Assessment of products  
 
Where risk assessments and controls are made to the product for an ongoing activity, it shall:  
1⁰ Be subject to periodic and frequency of review;  
2⁰ Be appropriate for the nature of the activity.  
 
Specific corrective actions shall be developed to prevent  the recurrence of instances where there have 
been deviations from established risk control measures, especially for high risks.  
The actions shall ensure that the risk is brought un der control as soon as possible in compliance with 
the established deviation handling procedures; and specific corrective actions shall be developed in 
advance for each identified risk including what is to be done when a deviation occurs, who is 
responsibl e for implementing the corrective actions, and that a record will be kept and maintained of 
the actions taken.  
 
Article  127: Manufacturer to conduct Risk review and keep records  
 
Every manufacturer shall have appropriate systems in place to ensure that the output of the Quality 
Risk Management process is periodically monitored and reviewed, as appropriate, to assess new 
information that may impact the original decision.  
Records and  documents associated with risk review shall be signed and dated by the person carrying 
out the review and by a responsible official of the quality unit of the company.  
 
  
  
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Article  128: Verification of Quality Risk Management process and methodologies  
 
A manufacturer shall carry on frequency verification to confirm the proper functioning of the Quality 
Risk Management process including:  
1⁰ Review of the Quality Risk Management process and its records;  
2⁰ Confirmation that identified risks is kept under control.  
 
Initial verification of the planned Quality Risk Management activities shall be considered necessary 
to determine whether the system is scientifically and technically sound to effectively control 
identified risks.  
 
Article 129: Risk communication and documentation  
 
Communication of the Quality Risk Management process shall be made to stakeholders engaged in 
both the data collection process for the risk assessment and the decision -making for risk control to 
ensure commitment and support for Quality Risk Management.  
The output of the Quality Risk Management process and associated risk analysis justifying the 
approach shall be documented and endorsed by the company's quality unit and management. The 
information shall be communicated  to stakeholders for their support.  
 
Article  130: Mitigation Plans  
 
A manufacturer shall have risk mitigation plans in place to apply where any risk to patient safety is 
posed or where multiple failures in systems occur, the mitigation plans shall be sufficiently robust to 
cover posed risks.  
 
Article 131: Training and education  
 
Every company or factory shall:  
1⁰ Train employees to understand Quality Risk Management,  
2⁰ Possess the skills necessary to apply it properly, and be appropriately resourced to enable the 
effective practice of the Quality Risk Management principles;  
3⁰ Develop a training program to support Quality Risk Management activities, working 
instructions and procedures drawn up to clarify the strategy and define the tasks of all involved 
in these activities; and  
4⁰ Provide specific training as required to enhance awareness to staff responsible for managing 
and reviewing risks who shall also receive formal training in the relevant procedures.  
 
Article  132: Responsibilities of Pharmaceutical manufacturer  
 
A pharmaceutical manufacturer shall form teams for conducting a Quality Risk Management process 
which shall involve experts in the appropriate areas in addition to individuals who are knowledgeable 
on the s ubject.   
  
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The extent of involvement and responsibility accountability shall be documented in a technical 
agreement or other equivalent document s between the individual and the pharmaceutical company.  
In the case of authorized person, it shall be important th at a company's internal procedures are clear 
on where the responsibility lies for final approval of risk acceptance documents.  
All effective matrix team leadership shall be required to take responsibility for coordinating Quality  
The head and team shall need to identify critical resources to progress the Quality Risk Management 
activities, and also specify a timeline, deliverables , and appropriate levels of decision -making for the 
Quality Risk Management process.  
 
Article  133: Complaint handling and investigation  
 
Handling and investigation of quality complaints shall be done following  written Standard Operating 
Procedures available at the site. The scope and depth of the investigation including whether a desk 
review or on -site inspection will be done shall be based on a risk assessment made.  
 
Article  134: Duty of Inspectors  
 
Inspectors shall assess whether a manufacturer has appropriate skills, scientific knowledge as well as 
product and process knowledge for the Quality Risk Management procedure being inspected.  
This shall include, but is not limited to:  
 
1⁰ A general approach to both planned and unplanned risk assessment and include s scope, 
responsibilities, controls, approvals, management systems, applicability , and exclusions;  
2⁰ Personnel with appropriate qualifications, experience , and training including their 
responsibilities  concerning  quality risk management being clearly defined;  
3⁰ Senior management should be involved in the identification and implementation of quality risk 
management principles within the company;  
4⁰ The risk management procedures for each area of application s hould be clearly defined;  
5⁰ Quality assurance principles shall be applied to quality risk management -related documentation 
such as review, approval, implementation , and archiving.  
 
CHAPTER XX: ACTIVE PHARMACEUTICAL INGREDIENTS  
 
Article 135: Active pharmaceutical ingredients  
 
Every manufacturer shall design Active Pharmaceutical Ingredients referred to as  "Active 
pharmaceutical ingredients”.  
Starting Material" as raw material, intermediate, can be used in the production of active 
pharmaceutical ingredients  
The manufacturer shall designate and document the rationale for the point at which production of the 
active pharmaceutical ingredients starting begins.  
 
  
  
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CHAPTER XXI: WASTE MANAGEMENT FOR MEDICINAL PRODUCT 
MANUFACTURERS AND INSPE CTION  
 
Article 136: Hazardous Waste  
 
A manufacturer shall ensure that hazardous waste pharmaceuticals involving antineoplastic agents, 
radioactive agents, hormonal products, penicillin , and solvents from the laboratory shall be 
segregated and managed.  
 
Article 137: Non-hazardous Pharmaceutical waste  
 
Non-Hazardous Pharmaceutical Waste comprised of all other pharmaceutical waste that  is not stated 
above shall be controlled subject to any environmental regulation on the force.  
In case of liquid effluent which poses a safety or contamination risk, the effluent shall be treated in 
Effluent Treatment Plant before being discharged to any municipal drain.  
 
CHAPTER XXII: CONDUCTING INSPECTIONS  
 
Article 138: Application for GMP Inspections  
 
The Authority shall inspect  to ensure  that: 
 
1⁰ Manufacturers comply with the requirements of these Regulations; and  
2⁰ Non-conformances against these Regulations are identified.  
 
The Authority upon receipt of duly filled application dossiers and appropriate proof of payment of 
GMP  inspection fees from the applicant  will schedule an inspection date for the premises as 
determined.  
All applicants that were found to be non -compliant during GMP inspection, shall provide a CAPA 
report within an identified period. The a pplicant will pay r e-inspection fees to the Authority before 
being re -inspected when CAPA has been submitted three times and was found unsatisfactory by the 
Authority.  
The Authority may serve a notice to manufacturers requiring them to furnish it with such information 
concer ning their compliance with these Regulations as shall be specified in the notice.  
Any manufacturer that receives an order or information following  paragraph 3 of this article shall 
provide the information requested within the period specified in the notic e. 
In the event of any serious adverse event or any serious adverse reaction or suspicion thereof, of the 
product manufactured by the manufacturer, the Authority shall request such information or conduct 
such inspections following  this regulation as shall be considered appropriate.  
 
 
  
  
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Article 139: Appointment of inspectors  
 
The Authority shall appoint inspectors to inspect domestic and overseas manufacturing facilities 
where medical products used in Rwanda are manufactured. The inspectors shall have the relevant 
qualification in terms of academic education, training , and experience to effectively take part in the 
inspection of  medical products manufacturing facilities.  
 
Article 140: Conflict of Interest  
 
To avoid any conflict of interest, all inspectors will declare any conflict of interest upon appointment.  
 
Article 141: Powers of inspectors  
 
To enforce  compliance for conducting inspections, an inspector appointed following  these 
regulations shall, upon production of evidence that he/she is so authorized, have the right:  
1⁰ During working hours  to enter any premises, other than premises used only as a private 
dwelling house, where he/she has reason to believe it is necessary to visit, including any 
premises of any person who carries out any of the activities referred to in these Regulations;  
2⁰ To carry o ut at those premises during the  visit, inspections, examinations, tests , and analyses 
as he/she considers necessary;  
3⁰ To require the production of; to inspect and take copies of; extracts from, any book, document, 
data or record in whatever form it i s held at, or in the case of computer data or records accessible 
at the premises;  
4⁰ To take possession of any samples for examination and analysis and any other article, 
substance, book, document, data  or record in whatever form they are held at, or in the c ase of 
computer data or records accessible at, the premises;  
5⁰ To question any person whom, he/she finds at the premises and has reasonable cause to believe 
can give relevant information;  
6⁰ To require any person to afford he/she such assistance as considered n ecessary concerning  any 
matter within that person's control, to which that person has responsibilities; and  
7⁰ To require, as considered necessary, any person to afford he/she such facilities as may 
reasonably require that person to afford. Nothing in this pa ragraph shall be taken to compel the 
production by any person of a document of which he/she would on grounds of legal 
professional privilege be entitled to withhold production.  
8⁰ To perform his or her duties with respect, confidentiality, humility and with i ntegrity.  
 
The inspector is required to collaborate with the local administration and a representative of the 
public investigation body of the area to enter premises that are closed or unoccupied. Together they 
shall provide written proof of the premises to be inspec ted before the inspection. The written proof 
stated under this paragraph shall be signed and where necessary photos of the premises must be added 
to prove the premises were closed or unoccupied before  physical inspection. The written proof shall 
be part of  the report that must be submitted to the Authority.   
  
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An inspector entering premises under  provisions of paragraph 1 of this Article, may take with him/her 
when entering those premises such equipment as may appear to be necessary and any person who is 
autho rized by the Authority to accompany him/her on that visit.  
Upon exiting any premises which an inspector is authorized to enter by a warrant under paragraph 2 
of this Article, he/she shall, if the premises are unoccupied, or the occupier is temporarily abse nt, 
leave the premises as effectively secured against trespassers as he/she found them.  
Where, pursuant to provisions of point 40 of this article, when an inspector takes possession of any 
article, substance, book, document, data , or record, he/she shall l eave at the premises with a 
responsible person, or if there is no such person present on the premises, leave in the premises in a 
prominent  
position, a detailed statement giving particulars of what was taken.  
Where, pursuant to provisions of point 40 of this article, an inspector takes a sample for analysis, the 
Authority may make such arrangements for analysis of that sample as considered appropriate.  
 
Article 142: Inspections  
 
Upon arrival at the inspection site, the inspectors shall convene a pre -inspection meeting with the 
inspected and the leading inspector shall preside over the meeting.  
The inspectors shall walk through every section of the plant, ask questions and carefully review 
recor ds and areas of the manufacturing sites , and may take photographs to support their observations.  
The inspectors shall list down all non -compliance findings in a document such as the Memorandum 
of Findings that conforms to the Authority’s standards.  
After i nspection, the inspectors shall convene a closing meeting highlighting issues observed during 
inspection and sign a memorandum form with the inspected.  
 
Article 143: Establishment of a scientific and advisory committee  
 
The Authority may establish a scientific and advisory committee comprising internal and/or external 
experts from different fields and scientific research to advise the Authority on Good Manufacturing 
Practices inspection matters.  
 
Article 144: Joint Inspection  
 
The Authority may participate in joint inspection with regulatory Authorities from other countries 
such as the East African Partner States and unless notified, these regulations shall apply.  
 
CHAPTER XXIII: FINAL PROVISIONS  
 
Article 145: Warnings, Suspensions , and revocations  
 
A warning letter, suspension , or revocation of the manufacturing authorization  shall be granted to the 
applicant where the Authority finds the applicant not complying with any of the requirements or 
conditions in these Regulations; or has ceased to be fit to carry on the regulated activities.   
  
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The Authority shall suspend or revoke a GMP certificate of a facility if the facility contravenes the 
following GMP requirements:  
Conditions for suspension  
1⁰ Any of the conditions under which the GMP certificate was issued no longer exist  
2⁰ The circumstances under which the approval was given no longer exist  
 
Conditions for issuing of warning letter  
3⁰ The information on which the approval was given is later found to be false,  
 
Conditions for revocation  
4⁰ Repeated violation of the regulatory administrative sanction or decision.  
 
Where the GMP certifica te is suspended or revoked, the Authority shall issue a notice to the 
management of the facility.  
 
The Authority shall take steps including suspension of registered medicinal product or closure to 
ensure that the manufacturing activity is stopped until oth erwise decided by the Authority.  
Measures towards enforcing this article may include the publication of the Rwanda FDA’s action on 
its website and other relevant media.  
 
Where the GMP certificate is revoked, the applicant must wait a determined period specified in the 
relevant guidelines before he/she is eligible to reapply for possible GMP certification, The GMP 
certification shall be re -instated only if the applicant meets the relevant requirements.  
 
Article 146: Restoration of a suspended or revoked GMP certificate  
 
Pursuant to article 146, the Authority may, upon satisfaction that the reasons for suspension or 
revocation of GMP certificate ha ve been corrected or if such reason for suspension/ revocation was 
unfounded.  
 
Article 147: Appeals  
 
An authorization holder or applicant may notify the Authority  of his or her grounds when he/she:  
1⁰ Objects to any suspension or revocation of the authorization, or any notice served;  
2⁰ Objects to the refusal of authorization or the imposition of any condition may notify the 
Authority of his desire to make written representations to, or be or appear before and be heard 
by, a person appointed by the Aut hority for that purpose.  
 
Any person aggrieved by a decision of the Authority may appeal to the Authority for review of a 
decision within 30 working days from the date of the notice. The Authority shall within 30 working 
days from the date of appeal review  the appeal and make its own decision whether to vary, reject or 
keep its own decision.   
  
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Where the Authority receives notification pursuant to provisions of paragraph 1 of this Article, the 
Authority shall appoint a person to consider the matter. The person  appointed shall determine the 
procedure to be followed concerning  the consideration of any objection.  
The person appointed by the Authority, shall consider any written or oral objections made by the 
objector or complainant in support of its objection, and  shall make a recommendation to the 
Authority.  
A recommendation shall be made in writing to the Authority, and a copy of it shall be sent to the 
complainant concerned, or to its nominated representative. The Authority shall take into account any 
recommend ation made within fourteen days of receipt of such recommendation.  
The Authority shall inform the complainant whether it accepts the recommendation and, if not, the 
reasons for its decision.  
If a person is dissatisfied with a decision after review, he/she may appeal to the supervising Authority 
of Rwanda FDA or the Minist er of Health whose decision shall be final.  
 
Article 148: Administrative sanctions  
 
Any person who contravenes the provisions of these Regulations shall be liable to the penalties 
prescribed in the Authority’s regulation  related to regulatory service tariff/fee and other applicable 
sanctions.  
The Authority shall take the following regulatory actions as recommended by the inspectors when 
making decisions on the outcome of inspections.  
 
1⁰ Minor non -compliances  
a) Corrective action within a given timeframe  
b) Request for compliance report  
 
2⁰ Major non -compliances  
c) issue warning letter  
d) request for corrective action within a given timeframe  
e) temporary withdrawal or suspension of marketing authorization  
f) Request for comprehensive compliance report  
g) Follow -up inspection to verify the implementation of corrective action within a given 
timeframe  
 
3⁰ Critical non -compliances include  
h) Permanent withdrawal of marketing authorization in case of registered products.  
i) Suspension of marketing authorization in case of registered products  
j) Refusal to grant marketing authorization for a new application.  
 
 
 
  
  
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Article 149: Publication of GMP -compliant facilities  
 
A pharmaceutical manufacturing facility that is granted with a certificate of compliance to GMP shall 
be published on monthly basis on the Rwanda FDA website, and on any other media, as the Authority 
may decide from time to time  
 
Article 150: Commencement  
 
These Regulations shall enter into force upon their approval and publication on the Authority’s 
website.  
End of Document