National Health Surveillance Agency    
www.anvisa.gov.br  
Public Consultation No 17 of 25 February 2010.  
Official Gazette of the Union of 02.03.2010  
The Board of the National Health Surveillance Agency  (ANVISA), in the exercise of 
the powers granted by Arti cle 11(IV) and Article 35 of ANVISA’s Regulations, approved 
by Decree No. 3029 of 16 April 1999, and having regard to the provisions of Article 54, 
indent (V) and paragraphs (1) and (3) of the Internal Regulations approved in accordance 
with Annex I to ANV ISA Administrative Ruling No. 354 of 11 August 2006, 
republished in the Official Gazette of the Union of 21 August 2006, at a meeting held on 
22 February 2010,  
hereby approves the following Public Consultation, and I, the Director -President, order 
its pub lication:  
Article 1. Criticisms and suggestions concerning the attached draft Resolution laying 
down provisions on the technical criteria for licensing the operation of medical gas 
companies may be submitted up to 30 (thirty) days from the date of publicat ion of this 
Public Consultation.  
Article 2. The full text of the draft Resolution is available on ANVISA’s website. 
Suggestions should be submitted in writing, using the dedicated form, to one of the 
following: Agência Nacional de Vigilância Sanitária/GIME P/GGIMP, SIA Trecho 5, 
Área Especial 57, Brasília - DF, CEP 71.205 -050; or by fax to: (61) 3462 - 5749; or by 
email to: cp17.2010@anvisa.gov.br . 
(1) The documentation to which this Public Consultation relates and the form for 
submission of contributions will  be available to interested parties at the internet address 
http://www.anvisa.gov.br/divulga/consulta/index.htm . 
(2) The contributions received will be public, and will remain available t o all on 
ANVISA’s website.  
(3) Contributions not sent using the abovementioned form or received outside the period 
will not be taken into consideration in the consolidation of the final text of the regulation.  
Article 3. At the end of the period mentioned in Article 1, the Agency will contact the 
bodies and entities involved and others who have expressed an interest in the matter so 
that they may designate representatives for subsequent discussions geared towards the 
consolidation of the final text.  
Sole pa ragraph. The consolidation of the final text of the regulation and the Report on the 
Analysis of the Contributions will be available on ANVISA’s website after the Board has 
completed its discussions.  
DIRCEU RAPOSO DE MELLO  
RESOLUTION OF THE COLLEGIATE DIRE CTORATE (RDC) NO xx OF xx 
XXXXXXXX 20XX  Laying down provisions on the technical criteria for licensing the operation of medical 
gas companies.  
The Board of the National Health Surveillance Agency , in the exercise of the powers 
granted by Article 11(IV) of the Regulation approved by Decree No  3029 of 16 April 
1999, and having regard to the provisions of indent (II) and paragraphs (1) and (3) of 
Article 54 of the Internal Regulations approved in accordance with Annex I of ANVISA 
Administrative Ruling No  354 o f 11 August 2006, republished in the Official Gazette of 
21 August 2006, at a meeting held on ________________, hereby adopts the following 
Collegiate Board Resolution and I, the Director -President, order its publication:  
Article 1. The Resolution laying d own provisions on the technical criteria for licensing 
the operation of medical gas companies is hereby approved.  
CHAPTER I  
INITIAL PROVISIONS  
Article 2. This Resolution lays down the minimum criteria to be met by companies that 
manufacture medical gases, for the purpose of licensing the operation of such companies.  
Sole paragraph. For the purposes of this Resolution, medical gases are defined as a gas or 
a mixture of gases intended to treat or prevent diseases in human beings or to be 
administered to human s for the purpose of medical diagnosis or to restore, correct or 
modify physiological functions.  
CHAPTER  II 
PHYSICAL INFRASTRUCTURE AND GENERAL PROCEDURES  
Article 3. The company or establishment manufacturing medical gases must possess 
suitable infrastruct ure, adopt administrative procedures and provide documentary 
evidence of its technical and operational capacity to manufacture and control medical 
gases with quality, safety and efficacy, and must:  
I – hold a permit or licence issued by competent bodies fo r its operation with 
regard to its location, environmental protection and safety of the installations;  
II –  present documentation showing the total area occupied;  
III – its restaurant/canteen, if any, must be located in an area that is separate from 
those  used for production and quality control activities, and must be kept in a suitably 
hygienic condition;  
IV – if there is no restaurant/canteen, the area used for eating must not pose any risks 
to the quality of the products;  
V – the changing facilities for  men and women must be in a suitably hygienic and 
sanitary condition;  
VI – drinking water fountains, if any, must be installed in appropriate locations and 
kept in a suitably hygienic and sanitary condition;  
VII – a fire safety plan must be in place for em ergencies. Equipment such as fire 
extinguishers and fire hoses must be correctly installed and be sufficient in number;  VIII – the environmental risk prevention programme must be structured in accordance 
with the regulations in force enacted by the Ministr y of Labour;  
IX – the company’s organisational chart must define and list the main roles and 
responsibilities of those in charge of production areas, quality control and quality 
assurance, and other key persons in the company;  
X – the training programme mu st cater to both the company’s own staff and any 
third parties involved in production or manufacture. The training programme must cover 
subjects relating to good manufacturing practice for medical gases, microbiology and 
personal hygiene; and  
XI – the comp any must have in place a formal system for product movement 
tracking.  
CHAPTER  III 
WAREHOUSES  
Section I  
External conditions  
Article 4. The exterior of the buildings used as warehouses must meet the following 
structural and other conditions:  
I – be in a goo d state of repair (no cracks, peeling paint or leaks);  
II  – the areas surrounding the warehouses must be clean and free of sources of 
environmental pollution in order not to pose any risk of contaminating the products and 
materials stored;  
III – access r oads must be kept clean in order not to pose any risk of contaminating 
the products and materials stored; and  
IV – be protected against the entry of rodents, insects, birds and other animals.  
Section II  
Internal conditions  
Article 5. The interior of the b uildings used as warehouses must meet the following 
structural and other conditions:  
I – floors, walls and ceilings must be kept in a good state of repair and in a suitably 
hygienic and sanitary condition by means of cleaning procedures in place for the se ctor; 
II – plumbing and drainage channels must be kept in a good state of repair;  
III – suitable levels of ventilation, lighting and temperature must be maintained in 
order to minimise the risk of accidents, avoid compromising the performance of 
operations  and preserve the quality and integrity of raw materials, materials and products;  
IV – electrical installations must be in a good state of repair, safe and properly 
identified;  V – safety equipment must be in place for fighting fires; and  
VI – there must b e demarcated areas or identification systems that guarantee the 
separation of the different materials and products (medical gases).  
CHAPTER IV  
RECEPTION AND STORAGE OF RAW MATERIALS  
Article 6. The following conditions must be met in areas where raw materi als, printed 
matter, packaging materials, products in bulk, finished products, and explosive and 
flammable materials are received and stored:  
I – written standard operating procedures must be in place for the reception, 
inspection, identification, stock in ventory and storage of the different materials listed;  
II – there must be areas or systems to restrict access by unauthorised persons and 
prevent the use of raw materials, labels, stamps, seals and other printed matter, bulk and 
finished products, explosiv e and flammable products and materials under quarantine 
before they are cleared by quality control; and  
III – there must be installations making it possible to safely store explosive and 
flammable products and materials in accordance with the approval of t he competent 
security body.  
CHAPTER V  
RETURN, COLLECTION AND STORAGE OF PRODUCTS  
Article 7. The return and recovery of cylinders, cryogenic tanks and products from the 
market must take place and be administered using standard operating procedures that 
include, as a minimum, the identification and restriction of their sale or inclusion in the 
production process before the investigation is completed and a decision has been taken as 
to the final destination of the products.  
Sole paragraph. Cylinders, cryogeni c tanks and products returned and recovered from the 
market must be stored in clearly identified areas that may not be freely accessed by 
unauthorised persons.  
CHAPTER VI  
WATER SYSTEMS  
Article 8. Concerning water systems and the associated installations u sed in the 
production of medical cases, the company must:  
I  – use water that is, as a minimum, potable in those production operations that 
have an impact on the quality of the product;  
II  – ensure that the water used, irrespective of the source thereof ( mains, artesian 
wells, etc.) is potable in accordance with the legislation in force by means of treatment, 
sampling and testing (regular physical -chemical and microbiological testing);  III  – adopt standard operating procedures for the treatment, sampling and testing of 
potable water and cleaning of the water storage systems, and establish the frequency of 
these operations;  
IV  – keep all storage tanks and conduits used to carry potable water in a good state 
of a repair so as not to compromise the productio n process and the quality of the 
products; and  
V  – provide installations and treatments for the disposal of used water, surplus 
materials and other waste resulting from the production process in a safe and hygienic 
manner in order to avoid any degradation  and destruction of the environment.  
CHAPTER  VII  
PRODUCTION AREAS  
Section I  
Internal and external conditions  
Article 9. Production areas must meet the following structural and other conditions:  
I – be in a good state of repair (no cracks, peeling paint o r leaks);  
II – be in a suitably hygienic and sanitary condition, protected against the entry of 
rodents, insects, birds and other animals;  
III – the areas surrounding production areas must be kept clean in order not to pose 
any risk of contaminating the pr oducts and materials;  
IV – floors, walls and ceilings must be kept in a good state of repair and in a suitably 
hygienic and sanitary condition by means of cleaning procedures in place for the sector;  
V – they must be of a suitable structure and size in ord er to permit a rational flow of 
production and avoid any mixing, contamination and cross -contamination of the various 
raw materials, materials and products;  
VI – the proportions of the layout must be suited to the volume of operations;  
VII – safety equipme nt (fire extinguishers and hoses) must be available, installed in 
suitable locations and properly identified;  
VIII – suitable levels of ventilation, lighting and temperature must be maintained in 
order to minimise the risk of accidents, avoid compromising the performance of 
operations and preserve the quality and integrity of raw materials, materials and products; 
and 
IX – electrical installations and conduits for potable water, used water and waste, 
vapours, gases and compressed air must be maintained in a  good state of repair and 
correctly identified.  
Section II  
Procedures, standard operating procedures, organisation and production activities  Article 10. With a view to standardising the activities of operators and the performance 
and organisation of produ ction activities, and in order to ensure the safety of the 
processes and the quality of the products (medical gases) the establishment/company 
must have in place:  
I – a procedure prohibiting eating, drinking and smoking in production areas;  
II – written an d approved procedures relating to safety regulations;  
III – standard operating procedures and procedures for in -process controls, to include 
a definition of the frequency of such tests and a description of the methods, materials and 
equipment used;  
IV – procedures restricting and controlling access by outsiders to production areas;  
V – written standard operating procedures for each of the stages in the 
manufacturing/production process, including references to the work stations, locations 
and equipment used;  
VI – written standard operating procedures for product filling (bottling) and labelling 
operations, storage and preservation of products;  
VII – written standard operating procedure defining the batch numbers used for the 
products manufactured (in bulk and  finished products);  
VIII – procedure or system guaranteeing the traceability of batches of products in bulk 
and finished products sent to health establishments and hospitals;  
IX – written standard operating procedures for inspections of cryogenic cylinder s 
and tanks, before and after filling; hydrostatic testing of cylinders and testing of valves. 
Cylinders, cryogenic tanks and valves that have been inspected must be kept completely 
separate from those that have not;  
X – standard operating procedure and st orage area permitting the complete 
separation of empty cylinders and those filled with medical gas, and the complete 
separation of the latter from those filled with gases for non -medical or industrial use;  
XI – standard operating procedure for the reconcil iation and/or distribution of 
packaging products and materials (including printed matter);  
XII – areas used for the storage of cryogenic cylinders, valves and tanks must be 
clean, dry, well -ventilated and free of explosive and flammable products and materi als. 
These areas must also be under cover and protected from extremes of temperature in 
order to prevent accidents, protect the abovementioned materials from the elements, and 
preserve their identification;  
XIII – standard operating procedures describing t he effective measures adopted to 
ensure that cryogenic cylinders and tanks used to bottle medicinal gases, but that are not 
used exclusively for this purpose, undergo treatment beforehand (inspection, tests, 
changes to labelling and painting) and that ther e is no mixing and/or contamination of 
medical gases with gases for non -medical or industrial use;  
XIV – standard operating procedures for the verification and clearance of production 
and bottling lines before operations in order to prevent any confusion o f materials (including printed matter) and contamination/cross -contamination of medical gases with 
each other and with gases for non -medical or industrial use;  
XV – standard operating procedures describing the effective measures adopted to 
ensure that ther e is no mixing and/or contamination/cross -contamination of medical 
gases with each other and with gases for non -medical or industrial use when the 
respective bottling lines are not used exclusively for a specific medical gas.  
Section III  
Classification, c alibration and maintenance of measuring and validation equipment, 
devices and instruments  
Article 11.  The company must have written and approved preventive maintenance, 
classification and/or calibration programmes for measuring equipment, devices and 
instruments.  
Article 12. The company must have in place written and approved schedules and master 
validation plans for the validation of computerised systems (used in the control and 
monitoring of processes), production processes and cleaning.  
Section IV  
Stand ardised master formulas and production dossiers  
Article 13. The company must have an approved standardised master formula for all of 
the medical gases and cryogenic liquids it produces.  
Article 14. The company must have an approved production dossier for e ach medical gas 
manufactured. Production dossiers must contain, as a minimum, the following 
information:  
I – name of the gas or gases in the mixture, date of manufacture, expiry date and 
the number and size of the batch of product;  
II – records and informa tion guaranteeing traceability in relation to the quantity and 
identification of raw materials, materials and printed matter used in the production;  
III – for reconciliation purposes, a record of the pre -fill capacity, by volume or 
weight, of the mobile cr yogenic cylinders and tanks, and a record of the post -fill volume 
or weight of the mobile cryogenic cylinders and tanks;  
IV – a list of the equipment used in the production/bottling of each product;  
V – a record of the start and finish date and time of all  of the stages in the 
manufacturing process, listing the locations, work stations and equipment used;  
VI – identification/signature of the operator(s) responsible for the performance and 
supervision of the production stages;  
VII – record of critical parame ters during the process, such as temperature, pressure 
and humidity;  VIII – identification/signature of the operator(s) responsible for cleaning the bottling 
lines and stations  and receiving, inspecting and emptying the cryogenic cylinders and 
tanks before  filling;  
IX – record of the results of in -process tests carried out;  
X – record of verification and calibration of testing equipment prior to the 
performance of in -process controls, as well as information on the reference gas(es) used 
in the verification and calibration of the testing equipment;  
XI – record of inspections and verifications of cryogenic cylinders, valves and tanks 
after filling, in order to ensure that the said recipients contain the correct quantity of 
product and have been filled complete ly; 
XII – data of notional yield and record of calculations of actual yield obtained and 
reconciliation of materials at critical stages of the process;  
XIII – serial number of the cylinders filled;  
XIV – samples of printed matter, such as seals and labels (including batch number, 
date of manufacture/filling and use -by date of the products) used for the packaging and 
identification of the products; and 
XV – record of any problems and discrepancies during the process; signature of the 
production manager, cert ifying his/her competency and approval of the performance of 
the investigation and adoption of corrective measures, taking account of all of the 
working procedures and guidelines approved and implemented, in order to maintain and 
guarantee the security of the process and the quality of the product.  
CHAPTER VIII  
QUALITY CONTROL  
Section I  
Quality Control Department, Facilities, Structures and Staff  
Article 15. Companies manufacturing medical gases and cryogenic liquids must have a 
quality control department  and laboratories with facilities, structures, testing equipment 
and safety equipment in sufficient number and suitable for testing of all raw materials, 
packaging materials, printed matter and products (semi -manufactured, in bulk and 
finished products) as  well as sufficient numbers of staff with the correct training and 
skills.  
(1) The premises of the quality control department must be kept organised and in a 
suitably hygienic and sanitary condition so as not to compromise the reliability of the 
tests, the  quality of the product or the safety of the operations and the testing staff.  
(2) The quality control department must be independent of the production.  
(3) Personal protective equipment must be sufficient and available for use by testing 
staff.  (4) Collec tive protective equipment such as eyewashes, showers and extinguishers must 
be present in sufficient numbers and be installed in areas that are clearly marked and with 
unobstructed access in emergencies.  
(5) Testing equipment must be installed and located in a rational manner so as to not 
suffer interference and compromise the test results.  
Section II  
Procedures, standard operating procedures, organisation, testing methodologies, 
tests and specifications  
Article 16. Written and approved testing specificati ons and methodologies must be in 
place for all raw materials, packaging materials, printed matter and products (semi -
manufactured, in bulk and finished products).  
Article 17. The company must have reference standards and gases for use in testing raw 
materi als and products and in calibrating and verifying measuring equipment, devices 
and instruments.  The reference standards and gases must be stored under the conditions 
recommended by the manufacturers in such a way as to maintain their purity, qualities 
and integrity.  
Article 18. Procedures must be in place prohibiting eating, drinking and smoking in 
production areas.  
Article 19. Written and approved standard operating procedures must be in place for the 
following:  
I – sampling, testing, approval and rejecti on of raw materials, packaging materials, 
printed matter and products (semi -manufactured, in bulk and finished products);  
II – clearance or rejection of raw materials, packaging materials, printed matter and 
products (semi -manufactured, in bulk and finishe d products) by the quality control 
manager;  
III – operation, verification and calibration of measuring equipment, devices and 
instruments;  
Section III  
Classification, calibration and maintenance of measuring and validation equipment, 
devices and instrumen ts 
Article 20. The company must have written and approved preventive maintenance, 
classification and/or calibration programmes for measuring equipment, devices and 
instruments.  
Article 21. The company must have in place written and approved schedules and m aster 
validation plans for the validation of testing methodologies.  CHAPTER IX  
FINAL AND TRANSITIONAL PROVISIONS  
Article 22. The establishments concerned by this Resolution shall have a period of 12 
months to make the modifications required for compliance  with the provisions of this 
Regulation.  
Article 23. Failure to comply with the provisions of this Resolution shall constitute a 
health infraction in accordance with Law No 6473 of 20 August 1977, notwithstanding 
any civil, administrative and criminal liab ility that may apply.  
Article 24. It falls to the National Health Monitoring System to not only monitor 
compliance with this instrument but also to ensure that the action taken is harmonised in 
accordance with the principles and rules of regionalisation an d the hierarchical 
organisation of the Unified Health System.  
Article 25. This Resolution shall come into force on the date of its publication.  
DIRCEU RAPOSO DE MELLO