FDA/GMP Audit-Checklist
Good Manufacturing Practices
Location of Facility
Inspected By
Date
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Month
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Day
Year
Date
Organizational & Management Responsibilities
Identifying the points to be checked regarding roles and responsibilities in FDA
Does this facility/business unit operate under a facility or corporate quality policy?
Yes
No
N/A
§211.22(a) Does a Quality Assurance Department exist as a separate organizational entity?
Yes
No
N/A
§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?
Yes
No
N/A
§211.22 Does the QA department or unit routinely review production records to ensure that procedures were followed and properly documented?
Yes
No
N/A
§211.22(b) Are adequate laboratory space, equipment, and qualified personnel available for required testing?
Yes
No
N/A
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?
Yes
No
N/A
§211.22(c) Are all QA procedures in writing?
Yes
No
N/A
§211.22(c) Are all QA responsibilities in writing?
Yes
No
N/A
§211.25 Are other QA personnel, e.g., chemists, analysts, laboratory technicians) qualified by way of training and experience?
Yes
No
N/A
§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?
Yes
No
N/A
§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?
Yes
No
N/A
§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??
Yes
No
N/A
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Employee Awareness/Training
Identifying the points to be checked regarding employees and training
Are GMP trainers qualified through experience and training?
Yes
No
N/A
§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?
Yes
No
N/A
§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?
Yes
No
N/A
§211.25(a) Does each employee receive retraining on an SOP (procedures) if critical changes have been made in the procedure?
Yes
No
N/A
§211.25(a) Are temporary employees given the same orientation as permanent employees?
Yes
No
N/A
§211.56(d) Are contractors and temporary employees required to perform their work under sanitary conditions?
Yes
No
N/A
§163 Are contractors qualified by experience or training to perform tasks that may influence the production, packaging, or holding of drug products?
Yes
No
N/A
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Sanitation and Hygiene
Identifying the points to be checked regarding the production of FDA products
Are protective measures taken to avoid direct contact of operators and materials(raw materials and drug products) and assuring protection of product from contamination as well as the safety of personnel?
Yes
No
N/A
§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?
Yes
No
N/A
§211.42(b) Is there sufficient space in the facility for the type of work and typical volume of production?
Yes
No
N/A
Is there any regulation for personnel entering the building and facility designated as limited access area?
Yes
No
N/A
Are smoking, eating, drinking, chewing or keeping plant, food, drink, smoking material and personal medicines restricted to specific areas and not permitted in production, laboratory, storage areas and other areas where they might adversely influence product quality?
Yes
No
N/A
Are employee's washing and toilet facilities adequate and in sufficient quantity?
Yes
No
N/A
Are there any procedure of qualification and validation of sanitation and hygiene available?
Yes
No
N/A
§211.56(a) Is this facility free from infestation by rodents, birds, insects and vermin?
Yes
No
N/A
§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?
Yes
No
N/A
Are cleaning agents changed from time to time?
Yes
No
N/A
§211.67(b)(5) Is clean equipment adequately protected against contamination prior to use?
Yes
No
N/A
Are cleaning methods monitored routinely by chemical and or microbiological method?
Yes
No
N/A
What are the cleaning methods/frequency for the water supply system, air handlingsystem and dust extraction system?
Yes
No
N/A
§211.67(b) Is equipment inspected immediately prior to use?
Yes
No
N/A
Additional comments
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Equipment
Identifying the points to checked for regarding equipment in production areas
§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?
Yes
No, it needs some work
N/A
Equipment indicates construction, validation and suitability of other materials (polypropylene, chrome plated brass, PVC, non-reactive plastic materials) provided?
Yes
No, it needs some work
N/A
§211.63 Is all equipment used to manufacture, process or hold a drug product of appropriate design and size for its intended use?
Yes
No
N/A
Are there procedures for cleaning and maintenance available? (Indicate responsibility, contractual details, maintenance routines which could affect product quality)
Yes
No
N/A
§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?
Yes
No
N/A
Has equipment used for cleaning maintained in a good fashion? (Indicate type,frequency, details of reports/modification, use of report)?
Yes
No
N/A
Is all equipment properly grounded where required?
Yes
No
N/A
§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?
Yes
No
N/A
Are the equipment surfaces encountering any raw material, intermediate bulk or finished product made of inert materials (e.g., stainless steel)
Yes
No
N/A
Are all open mechanical belts, pulley, etc. equipped with safety guards?
Yes
No
N/A
§211.105 Are all pieces of equipment clearly identified with easily visible markings?
Yes
No
N/A
§211.105(b) Are all pieces of equipment also marked with an identification number that corresponds with an entry in an equipment log?
Yes
No
N/A
Is there any program for calibration of measuring equipment?
Yes
No
N/A
§211.67(c) Are written records maintained on equipment cleaning, sanitizing and maintenance on or near each piece of equipment?
Yes
No
N/A
§211.67(b)(1) Does a written procedure assign responsibility for the cleaning and maintenance of equipment?
Yes
No
N/A
§211.63 Is each piece of equipment identified to its minimum and maximum capacities and minimum and maximum operating speeds for valid results?
Yes
No
N/A
Additional comments
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Receipt of Materials/Lab Testing
Identifying the points via receipt of materials/ lab testing
§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.)
Yes
No
N/A
§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?
Yes
No
N/A
§211.82(a) Does inspection start with visual examination of each shipping container for appropriate labeling, signs of damage, or contamination?
Yes
No
N/A
§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?
Yes
No
N/A
§211.160(b) Is the sampling technique written and followed for each type of sample collected?
Yes
No
N/A
§211.84(c)(2) Containers are cleaned before samples are removed.
Yes
No
N/A
§211.84(c)(5) Containers from which samples have been taken are so marked indicating date and approximate amount taken.
Yes
No
N/A
§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.
Yes
No
N/A
§211.84(d)(6) Microbiological testing is conducted where appropriate.
Yes
No
N/A
§211.42(b) Are incoming material and components quarantined until approved for use?
Yes
No
N/A
§211.122(d) Are labels for different products, strengths, dosage forms, etc., stored separately with suitable identification?
Yes
No
N/A
Is label storage area limited to authorized personnel?
Yes
No
N/A
§211.89 Are rejected components, material, and containers quarantined and clearly marked to prevent their use?
Yes
No
N/A
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Inventory Control Measures
Identifying the points regarding inventory control measures
§211.142 Are inventory control procedures written?
Yes
No
N/A
§211.150(a) Is stock rotated to ensure that the oldest approved product or material is used first?
Yes
No
N/A
§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?
Yes
No
N/A
§211.87 Do written procedures identify storage time beyond which components, containers, and closures must be reexamined before use?
Yes
No
N/A
§211.87 Is release of retested material clearly identified for use?
Yes
No
N/A
§211.101(c) Is the addition of each component documented by the person adding the material during manufacturing?
Yes
No
N/A
§211.101(d) Does a second person observe each addition of material and document verification with a second signature?
Yes
No
N/A
§211.125(a) Does a written procedure specify who is authorized to issue labels?
Yes
No
N/A
§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?
Yes
No
N/A
§211.125(d) Do written procedures call for destruction of excess labeling on which lot or control numbers have been stamped or imprinted?
Yes
No
N/A
§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?
Yes
No
N/A
§211.67(b)(3) Do written procedures detail any disconnection and reassembly required to verify readiness for use?
Yes
No
N/A
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Process Control and Operational Validation
Identifying the points to be checked via process control and operational validation
§211.100(a) Does the process control address all issues to ensure identity, strength, quality and purity of product?
Yes
No
N/A
§211.101(a) Does the procedure include formulation that is written to yield not less than 100% of established amount of active ingredients?
Yes
No
N/A
§211.101(c) Are all weighing and measuring preformed by one qualified person and observed by a second person?
Yes
No
N/A
§211.101(d) Have records indicated preceding policy been followed by presence of two signatures?
Yes
No
N/A
§211.103 Are actual yields calculated at the conclusion of appropriate phases of the operation and at the end of the process?
Yes
No
N/A
§211.103 Are calculations performed by one person? Is there independent verification by a second person?
Yes
No
N/A
§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?
Yes
No
N/A
§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?
Yes
No
N/A
§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?
Yes
No
N/A
§211.115(a) Do written procedures identify steps for reprocessing batches?
Yes
No
N/A
§211.115(b) Are quality control review and approval required for any and all reprocessing of material?
Yes
No
N/A
Does a written procedure outline steps required to reprocess returned drug products (if it can be determined that such products have not been subjected to improper storage conditions?)
Yes
No
N/A
Does Quality Control review such reprocessed returned goods and test such material for conformance to specifications before releasing such material for resale?
Yes
No
N/A
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Finished Product Verification, Storage, and Handling
Identifying the points to be checked regarding finished product
§211.30 Do written procedures indicate how and who verifies that correct containers and packages are used for finished product during the finishing operation?
Yes
No
N/A
§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?
Yes
No
N/A
§211.137(a) Are expiration dates stamped or imprinted on labels?
Yes
No
N/A
§211.137(b) Are expiration dates related to any storage conditions stated on the label?
Yes
No
N/A
§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?
Yes
No
N/A
§211.142(o) Is finished product stored under appropriate conditions of temperature, humidity, light, etc.
Yes
No
N/A
§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.)
Yes
No
N/A
§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?
Yes
No
N/A
§211.167(c) Do controlled release or sustained release products include tests to determine conformance to release time specification?
Yes
No
N/A
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Product Distribution Controls
Identifying the points to be checked regarding distrubution
§211.150(a) Does a written procedure manage stocks to ensure that oldest approved product is sold first?
Yes
No
N/A
§211.150(a) Are deviations to the policy above documented?
Yes
No
N/A
§211.150(a) Does a written procedure identify the steps required if a product recall is necessary?
Yes
No
N/A
Is the recall policy current and adequate?
Yes
No
N/A
§211.198(a) Are complaints, whether received in oral or written form, documented in writing and retained in a designated file?
Yes
No
N/A
§211.198(a) Are complaints reviewed on a timely basis by the Quality Control Unit?
Yes
No
N/A
§211.198(b)(1) Is the action taken in response to each complaint documented?
Yes
No
N/A
§211.198(b)(3) Are decisions not to investigate a complaint also documented and the name of the responsible person documented?
Yes
No
N/A
§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?
Yes
No
N/A
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Security
Identifying the points to be checked regarding security measures
Is up-dated organization chart showing an arrangement for quality assurance including production and quality control available?
Yes
No
N/A
Does this facility have a formal, written security policy?
Yes
No
N/A
Is access to the facility restricted?
Yes
No
N/A
Are production and Quality Assurance/ Quality control functions independent of each other?
Yes
No
N/A
Are all unit areas adequately staffed?
Yes
No
N/A
Is there proper supervision in every unit?
Yes
No
N/A
Is hiring of an employee proceeded by a medical examination test for possible adverse allergic reaction to chemicals?
Yes
No
N/A
Is medical assistance available during the normal working hours (ex: CertifiedFirst Aid/CPR responders ?
Yes
No
N/A
Have all personnel received initial GMP training?
Yes
No
N/A
Have all personnel received the most recent standards regarding GMP?
Yes
No
N/A
§211.44 Is lighting adequate in all areas?
Yes
No
N/A
§211.46 Is adequate ventilation provided?
Yes
No
N/A
§211.46 Is control of air pressure, dust, humidity and temperature adequate for the manufacture, processing, storage or testing of drug products?
Yes
No
N/A
Are there any sources of pollution (industrial or other) in the neighborhood of the building?
Yes
No
N/A
Is the facility constructed to protect against weather damage, flood, ground seepage?
Yes
No
N/A
Are floors, walls and ceilings constructed of materials which will facilitate easy cleaning and of necessary disinfections?
Yes
No
N/A
Is there an adequate working space for orderly and logical placement of equipment and materials, the efficient flow of work, effective communication?
Yes
No
N/A
Are buildings and facilities properly constructed to facilitate smooth operation and adequate cleaning?
Yes
No
N/A
Are there preventative maintenance and servicing programs available?
Yes
No
N/A
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