Source: http://www.auditing.com/audit_checklist_for_GMP.htm
Timestamp: 2013-05-26 06:36:44
Document Index: 51466892

Matched Legal Cases: ['art 11', 'art 820', 'art 110', 'art 111', 'art 210', 'art 820']

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Audit Checklist for Drug Industry
Get an independent Part 11 Computer Systems, 210/211 Drug GMPs, Part 820 - Quality Systems, and/or Validation Today! Last Updated: August 04, 2012
Developed by John Cuspilich, Sr. Consultant/Auditor,
To get a copy of the check list sent to you, please send an email request to jcuspilich@auditing.com
In addition, we highly recommend and value your input, comments and suggestions for proper audit of the check list issues. To respond to each issue, email the issue and comment to
The following checklist is intended to aid in the systematic GMP audit of a facility that manufactures drug components or finished products.
The adequacy of any procedures is subject to the interpretation of the auditor. Therefore, the author accepts no liability for any subsequent regulatory observations or actions stemming from the use of this audit checklist.
Instructions for Using this Audit Checklist
The checklist is to be used with a notebook into which detailed entries can be made during the audit. While the checklist is to guide the auditor, is not intended to be a substitute for knowledge of the GMP regulations. Although a single question may be included about any requirement, the answer will usually be a multi-part one since the auditor should determine the audit trail for several products that may use many different components. Enter details in your notebook and cross reference your comments with the questions. At least three production batches should be selected for thorough analysis to include: (a) traceability of all components or materials used in the subject batches, (b) documentation of raw material or component, in-process, and finished goods testing for the subject product batches, (c) warehousing and distribution records as they would relate to a possible recall. Responses entered on the checklist should be consistent. "X" is recommended for "NO"; a checkmark for "YES"; "n/a" for not applicable to questions that do not apply. An asterisk and notebook page number should be entered on the checklist to identify where relevant comments or questions are recorded in your notebook. The notebook used should be a laboratory-type notebook with bound pages. the notebook should be clearly labeled as to the audit type, date, and auditor(s). Many auditors prefer to use a notebook for a single audit so it may be filed with the checklist and the final report. The references to sections in the GMP regulation are for your convenience should a question arise. In some instances, two or more sections within the GMP regulation may have bearing on a specific subject. The headings in the GMP regulation will usually offer some guidance on the areas covered in each section. A general suggestion for a successful audit is to spend most of your time on major issues and a smaller portion of your time on small issues. there may be observations that you may wish to point out to supervisory personnel that deserve attention, but do not belong in an audit report because they are relatively insignificant. By the same token, too many small items suggests a trend of non-compliance and deserve attention as such. When citing these, be specific. GMP Auditing GMP Audit GMP Audit - GMP Auditing
General Controls Does the facility and its departments (organizational units) operate in a state of control as defined by the GMP regulations?
Is there documented proof to substantiate the finding?
GMPs for the Food Industry (21 CFR Part 110)? Yes ___ No ___
GMPs for the Dietary Supplements Industry (21 CFR Part 111)? Yes ___ No ___
GMPs for the Drug Industry (21 CFR Part 210/211)? Yes ___ No ___
GMPs for the Medical Device Industry (21 CFR Part 820)? Yes ___ No ___
GMPs for Active Pharmaceutical Ingredients (ICH Q7)? Yes ___ No ___ 1.1
Is there a formal corporate quality manual (ICH Q10)?
�211.22(a) Does a Quality Assurance unit (department) exist as a separate organizational entity?
Is there proof that no conflict of interest exists within the organization?
Where does the QA unit position itself on the organizational chart?
�211.22(a) Does the Quality Assurance unit alone have both the authority and responsibility to approve or reject all components, drug product containers and closures, in-process materials, packaging materials, labeling and drug products?
Is the authority and responsibility supported by corporate management?
�211.22 Does the QA department or unit routinely review production records to ensure that procedures were followed and properly documented?
�211.22(b) Are adequate laboratory space, equipment, and qualified personnel available to perform testing and operations at the Auditee's facilities?
If any portion of testing is performed by a contractor, has the Quality Assurance unit inspected the contractor�s site and verified that the laboratory space, equipment, qualified personnel and procedures are adequate?
Has those facilities undergone appropriate risk assessments and auditing if applicable?
Is there a formal documented calendar plan for inspections available for review? Is there a documented list of previous inspection dates? Date of last inspection:____________________
�211.22(c) Are all QA procedures in writing?
�211.22(c) Are all QA responsibilities in writing?
�211.25 Are QA supervisory personnel qualified by way of training and experience?
�211.25 Are other QA personnel, e.g., chemists, analysts, laboratory technicians) qualified by way of training and experience?
�211.22(a) Does the QA unit have a person or department specifically charged with the responsibility of designing, revising, and obtaining approval for production and testing procedures, forms, and records?
�211.22(d) Does a written SOP, which identifies how the form is to be completed and who signs and countersigns, exist for each record or form?
�211.165(a)(b)(c) Is the production batch record and release test results reviewed for accuracy and completeness before a batch/lot of finished product is released?
�211.25(a) Does each employee receive retraining on an SOP (procedures) if critical changes have been made in the procedure?
�211.25 is all training documented in writing that indicates the date of the training, the type of training, and the signature of both the employee and the trainer?
�211.25 Are training records readily retrievable in a manner that enables one to determine what training an employee has received, which employees have been trained on a particular procedure, or have attended a particular training program?
�211.25(a) Are supervisory personnel instructed to prohibit any employee who, because of any physical condition (as determined by medical examination or supervisory observation) that may adversely affect the safety or quality of drug products, from coming into direct contact with any drug component or immediate containers for finished product?
�211.28(d) Are employees required to report to supervisory personnel any health or physical condition that may have an adverse effect on drug product safety and purity?
�211.25(a) Are temporary employees given the same orientation as permanent employees?
�211.34 Are consultants, who are hired to advise on any aspect of manufacture, processing, packing or holding, of approval for release of drug products, asked to provide evidence of their education, training, and experience?
�211.34 Are written records maintained stating the name, address, qualifications, and date of service for any consultants and the type of service they provide?
Design Control Not directly related to the Drug Regulation
3.1 Facility Design and Layout 3.101
�211.42(a) Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testing, and holding of drug products?
�211.42(b) Is there sufficient space in the facility for the type of work and typical volume of production?
�211.44 Is lighting adequate in all areas?
�211.46 Is adequate ventilation provided?
�211.46 Is control of air pressure, dust, humidity and temperature adequate for the manufacture, processing, storage or testing of drug products?
�211.46 If air filters are used, is there a written procedure specifying the frequency of inspection and replacement?
�211.42(d) Does the facility have separate air handling systems, if required, to prevent contamination? (MANDATORY IF PENICILLIN IS PRESENT!)
�211.56(a) Is this facility free from infestation by rodents, birds, insects and vermin?
�211.56(c) Does this facility have written procedures for the safe use of suitable, (e.g. those that are properly registered) rodenticides, insecticides, fungicides, and fumigating agents?
Does this facility have written procedures that describe in sufficient detail the cleaning schedule, methods, equipment and material?
�211.58 Are all parts of the facility maintained in a good state of repair?
�211.52 Is sewage, trash and other refuse disposed of in a safe and sanitary manner (and with sufficient frequency?)
�211.56(d) Are contractors and temporary employees required to perform their work under sanitary conditions?
�211.63 Is all equipment used to manufacture, process or hold a drug product of appropriate design and size for its intended use?
�211.65(a) Are machine surfaces that contact materials or finished goods non-reactive, non-absorptive, and non-additive so as not to affect the product?
�211.65(b) Are design and operating precautions taken to ensure that lubricants or coolants or other operating substances do NOT come into contact with drug components or finished product?
�211.72 Fiber-releasing filters are NOT used in the production of injectable products?
� 211.72 Asbestos filters are NOT used in the production of products?
�211.67(a)(b) Are written procedures available for each piece of equipment used in the manufacturing, processing or holding of components, in-process material or finished product?
�211.105 Are all pieces of equipment clearly identified with easily visible markings?
�211.105(b) Are all pieces of equipment also marked with an identification number that corresponds with an entry in an equipment log?
�211.67(b) Are written procedures established for the cleaning and maintenance of equipment and utensils?
�211.67(b)(1) Does a written procedure assign responsibility for the cleaning and maintenance of equipment?
�211.67(b)(2) Has a written schedule been established and is it followed for the maintenance and cleaning of equipment?
�211.67(b)(2) If appropriate, is the equipment sanitized using a procedure written for this task?
�211.67(b)(3) Has a sufficiently detailed cleaning and maintenance procedure been written for each different piece of equipment to identify any necessary disassembly and reassembly required to provide cleaning and maintenance?
�211.67(b)(3) Does the procedure specify the removal or obliteration of production batch information from each piece of equipment during its cleaning?
�211.67(b)(5) Is clean equipment adequately protected against contamination prior to use?
�211.67(b) Is equipment inspected immediately prior to use?
�211.67(c) Are written records maintained on equipment cleaning, sanitizing and maintenance on or near each piece of equipment?
�211.68(a) Does the facility have approved written procedures for checking and calibration of each piece of measurement equipment? (Verify procedure and log for each piece of equipment and note exceptions in notebook with cross reference.)
�211.68(a) Are records of calibration checks and inspections maintained in a readily retrievable manner?
�211.63 Verify that all pieces of equipment used in production, packaging, and quality assurance are capable of producing valid results.
�211.68(a) When computers are used to automate production or quality testing, have the computer and software been validated?
�211.63 Is each piece of equipment identified to its minimum and maximum capacities and minimum and maximum operating speeds for valid results?
�211.80(a) Does the facility have current written procedures for acceptance/rejections of drug products, containers, closures, labeling and packaging materials? (List selected materials and components in notebook and verify procedures.)
�211.80(d) Is each lot within each shipment of material or components assigned a distinctive code so material or component can be traced through manufacturing and distribution?
�211.82(a) Does inspection start with visual examination of each shipping container for appropriate labeling, signs of damage, or contamination?
�211.82(b) Is the number of representative samples taken from a container or lot based on statistical criteria and experience with each type of material or component?
�211.160(b) Is the sampling technique written and followed for each type of sample collected?
�211.84(c)(2) Containers are cleaned before samples are removed.
�211.84(c)(4) Stratified samples are not composited for analysis.
�211.84(c)(5) Containers from which samples have been taken are so marked indicating date and approximate amount taken.
�211.84(d)(1)(2) At least one test is conducted to confirm the identity of a raw material (bulk chemical or pharmaceutical) when a Certificate of Analysis is provided by supplier and accepted by QA.
�211.84(d)(6) Microbiological testing is conducted where appropriate.
�211.42(b) Are incoming material and components quarantined until approved for use?
�211.122(d) Are labels for different products, strengths, dosage forms, etc., stored separately with suitable identification?
�211.89 Are rejected components, material, and containers quarantined and clearly marked to prevent their use?
�211.142 Are inventory control procedures written?
�211.150(a) Is stock rotated to ensure that the oldest approved product or material is used first?
�211.184(e) Is destruction of materials documented in a way that clearly identifies the material destroyed and the date on which destruction took place?
�211.87 Do written procedures identify storage time beyond which components, containers, and closures must be reexamined before use?
�211.87 Is release of retested material clearly identified for use?
Do these procedures include (1) release by QC, (2)Documentation of correct weight or measure, and (3) Proper identification of containers?
�211.101(c) Is the addition of each component documented by the person adding the material during manufacturing?
�211.101(d) Does a second person observe each addition of material and document verification with a second signature?
�211.125(a) Does a written procedure specify who is authorized to issue labels?
�211.125(a) Does a written procedure specify how labels are issued, used, reconciled with production, returned when unused, and the specific steps for evaluation of any discrepancies?
�211.125(d) Do written procedures call for destruction of excess labeling on which lot or control numbers have been stamped or imprinted?
�211.67(b)(5) Do written procedures detail how equipment is to be checked immediately prior to use for cleanliness, removal of any labels and labeling from prior print operations?
�211.67(b)(3) Do written procedures detail any disconnection and reassembly required to verify readiness for use?
�211.100(a) Does the process control address all issues to ensure identity, strength, quality and purity of product?
��211.101(a) Does the procedure include formulation that is written to yield not less than 100% of established amount of active ingredients?
�211.101(c) Are all weighing and measuring preformed by one qualified person and observed by a second person?
�211.101(d) Have records indicated preceding policy been followed by presence of two signatures?
�211.103 Are actual yields calculated at the conclusion of appropriate phases of the operation and at the end of the process?
�211.103 Are calculations performed by one person? Is there independent verification by a second person?
�211.110(a) Are written procedures established to monitor output and validate the performance of manufacturing procedures that may cause variability in characteristics of in-process materials and finished drug products?
�211.110(c) Are in-process materials tested at appropriate phases for identity, strength, quality, purity and are they approved or rejected by Quality Control?
�211.160(b) Are there laboratory controls including sampling and testing procedures to assure conformance of components, containers, closures, in-process materials, and finished product specifications?
�211.115(a) Do written procedures identify steps for reprocessing batches?
�211.115(b) Are quality control review and approval required for any and all reprocessing of material?
�211.30 Do written procedures indicate how and who verifies that correct containers and packages are used for finished product during the finishing operation?
�211.134(a) In addition, do written procedures require that representative sample of units be visually examined upon completion of packaging to verify correct labeling?
�211.137(a) Are expiration dates stamped or imprinted on labels?
�211.137(b) Are expiration dates related to any storage conditions stated on the label?
�211.142(a) Are all finished products held in quarantine until QC has completed its testing and releases product on a batch to batch basis for sale?
�211.142(o) Is finished product stored under appropriate conditions of temperature, humidity, light, etc.
�211.166 Has the formulation for each product been tested for stability based on a written protocol? (Containers must duplicate those used in final product packaging.)
�211.166 Are written sampling and testing procedures and acceptance criteria available for each product to ensure conformance to finished product specifications?
�211.170(a) Is a quantity of samples equal to at least twice the quantity needed for finished product release testing maintained as a reserve sample?
�211.167(a) Are sterility and pyrogen testing performed as required?
�211.167(b) Are specific tests for foreign particles or abrasives included for any ophthalmic ointments?
�211.167(c) Do controlled release or sustained release products include tests to determine conformance to release time specification?
�211.150(a) Does a written procedure manage stocks to ensure that oldest approved product is sold first?
�211.150(a) Are deviations to the policy above documented?
�211.150(a) Does a written procedure identify the steps required if a product recall is necessary?
�211.198(a) Are complaints, whether received in oral or written form, documented in writing and retained in a designated file?
�211.198(a) Are complaints reviewed on a timely basis by the Quality Control Unit?
�211.198(b)(1) Is the action taken in response to each complaint documented? 7.504
�211.198(b)(3) Are decisions not to investigate a complaint also documented and the name of the responsible person documented?
�211.198(b)(2) Are complaint investigations documented and do they include investigation steps, findings, and follow-up steps, if required? Are dates included for each entry?