Pharmaceutical GMP Audit Checklist

• Conducted on

  Date

• Prepared by

• Location
  Address

Organizational & Management Responsibilities

• Does this facility/business unit operate under a facility or corporate quality policy?

  Yes

  No

  N/A

• Does a Quality Assurance unit (department) exist as a separate organizational entity?

  Yes

  No

  N/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

• Does the QA department or unit routinely review production records to ensure that procedures were followed and properly documented?

  Yes

  No

  N/A

• 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

• Are all QA procedures in writing?

  Yes

  No

  N/A

• Are all QA responsibilities in writing?

  Yes

  No

  N/A

• Are all written QA procedures current and approved? (Review log of procedures)

  Yes

  No

  N/A

• Are the procedures followed? (Examine records to ensure consistent record- keeping that adequately documents testing.)

  Yes

  No

  N/A

• Are QA supervisory personnel qualified by way of training and experience?

  Yes

  No

  N/A

• "Are other QA personnel, e.g., chemists, analysts, laboratory technicians)

  Yes

  No

  N/A

• qualified by way of training and experience?"

  Yes

  No

  N/A

Document Control Program

• 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

• 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

• 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

Employee Orientation, Quality Awareness, and Job Training

• Circle the types of orientation provided to each new employee: (1) Company brochure (2) Literature describing GMP regulations and stressing importance of following instructions. (3) On-the-job training for each function to be performed (before the employee is allowed to perform such tasks). (4) Other: enter in notebook.

  Yes

  No

  N/A

• Does each employee receive retraining on an SOP (procedures) if critical changes have been made in the procedure?

  Yes

  No

  N/A

• Indicate how on-going, periodic GMP training is accomplished.

• 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

• 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

• Are GMP trainers qualified through experience and training?

  Yes

  No

  N/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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• Are temporary employees given the same orientation as permanent employees?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• Are written records maintained stating the name, address, qualifications, and date of service for any consultants and the type of service they provide?

  Yes

  No

  N/A

Plant Safety and Security

• Does this facility have a facility or corporate safety program?

  Yes

  No

  N/A

• Are safety procedures written?

  Yes

  No

  N/A

• Are safety procedures current?

  Yes

  No

  N/A

• Do employees receive safety orientation before working in the plant area?

  Yes

  No

  N/A

• Is safety training documented in a readily retrievable manner that states the name of the employee, the type of training, the date of the training, and the name of the trainer and the signature of the trainer and the participant?

  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

• Describe how entry is monitored/restricted:

  Yes

  No

  N/A

• Is a security person available 24 hours per day?

  Yes

  No

  N/A

Internal Quality/GMP Audit Program

• Does this business unit/facility have a written quality policy?

  Yes

  No

  N/A

• Is a copy of this quality policy furnished to all employees?

  Yes

  No

  N/A

• Is training provided in quality improvement?

  Yes

  No

  N/A

• Does a formal auditing function exist in the Quality Assurance department?

  Yes

  No

  N/A

• Does a written SOP specify who shall conduct audits and qualifications (education, training, and experience) for those who conduct audits?

  Yes

  No

  N/A

• Does a written SOP specify the scope and frequency of audits and how such audits are to be documented?

  Yes

  No

  N/A

• Does a written SOP specify the distribution of the audit report?

  Yes

  No

  N/A

Quality Cost Program

• Does this facility have a periodic and formal review of the cost of quality?

  Yes

  No

  N/A

• Does this facility have the ability, through personnel, software, and accounting records, to identify and capture quality costs?

  Yes

  No

  N/A

• Does this facility make a conscious effort to reduce quality costs?

  Yes

  No

  N/A

Facility Design and Layout

• 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

• Is there sufficient space in the facility for the type of work and typical volume of production?

  Yes

  No

  N/A

• Does the layout and organization of the facility prevent contamination?

  Yes

  No

  N/A

Environmental Control Program

• The facility is NOT situated in a location that potentially subjects workers or product to particulate matter, fumes, or infestations?

  Yes

  No

  N/A

• Are grounds free of standing water?

  Yes

  No

  N/A

• Is lighting adequate in all areas?

  Yes

  No

  N/A

• Is adequate ventilation provided?

  Yes

  No

  N/A

• Is control of air pressure, dust, humidity and temperature adequate for the manufacture, processing, storage or testing of drug products?

  Yes

  No

  N/A

• If air filters are used, is there a written procedure specifying the frequency of inspection and replacement?

  Yes

  No

  N/A

• Are drains and routine cleaning procedures sufficient to prevent standing water inside the facility?

  Yes

  No

  N/A

• Does the facility have separate air handling systems, if required, to prevent contamination? (MANDATORY IF PENICILLIN IS PRESENT!)

  Yes

  No

  N/A

Facility Maintenance and Good Housekeeping Program

• Is this facility free from infestation by rodents, birds, insects and vermin?

  Yes

  No

  N/A

• 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

• Is this facility maintained in a clean and sanitary condition?

  Yes

  No

  N/A

• Does this facility have written procedures that describe in sufficient detail the cleaning schedule, methods, equipment, and material?

  Yes

  No

  N/A

• Does this facility have written procedures for the safe and correct use of cleaning and sanitizing agents?

  Yes

  No

  N/A

• Are all parts of the facility maintained in a good state of repair?

  Yes

  No

  N/A

• Is sewage, trash and other refuse disposed of in a safe and sanitary manner (and with sufficient frequency?)

  Yes

  No

  N/A

Outside Contractor Control Program

• Are contractors and temporary employees required to perform their work under sanitary conditions?

  Yes

  No

  N/A

• 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

Design and Placement

• 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 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

• 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?

  Yes

  No

  N/A

• Fiber-releasing filters are NOT used in the production of injectable products?

  Yes

  No

  N/A

• Asbestos filters are NOT used in the production of products?

  Yes

  No

  N/A

• Is each idle piece of equipment clearly marked ""needs cleaning"" or ""cleaned; ready for service""?"

  Yes

  No

  N/A

• Is equipment cleaned promptly after use?

  Yes

  No

  N/A

• Is idle equipment stored in a designated area?

  Yes

  No

  N/A

• 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

  N/A

• Do cleaning instructions include disassembly and drainage procedure, if required, to ensure that no cleaning solution or rinse remains in the equipment?

  Yes

  No

  N/A

Equipment Identification

• Are all pieces of equipment clearly identified with easily visible markings?

  Yes

  No

  N/A

• Are all pieces of equipment also marked with an identification number that corresponds with an entry in an equipment log?

  Yes

  No

  N/A

• Does each piece of equipment have written instructions for maintenance that includes a schedule for maintenance?

  Yes

  No

  N/A

• Is the maintenance log for each piece of equipment kept on or near the equipment?

  Yes

  No

  N/A

Equipment Maintenance & Cleaning

• Are written procedures established for the cleaning and maintenance of equipment and utensils?

  Yes

  No

  N/A

• Are these procedures followed?

  Yes

  No

  N/A

• Does a written procedure assign responsibility for the cleaning and maintenance of equipment?

  Yes

  No

  N/A

• Has a written schedule been established and is it followed for the maintenance and cleaning of equipment?

  Yes

  No

  N/A

• Has the cleaning procedure been properly validated?

  Yes

  No

  N/A

• If appropriate, is the equipment sanitized using a procedure written for this task?

  Yes

  No

  N/A

• 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

• Does the procedure specify the removal or obliteration of production batch information from each piece of equipment during its cleaning?

  Yes

  No

  N/A

• Is equipment cleaned promptly after use?

  Yes

  No

  N/A

• Is clean equipment clearly identified as "clean" with a cleaning date shown on the equipment?

  Yes

  No

  N/A

• Is clean equipment adequately protected against contamination prior to use?

  Yes

  No

  N/A

• Is equipment inspected immediately prior to use?

  Yes

  No

  N/A

• Are written records maintained on equipment cleaning, sanitizing, and maintenance on or near each piece of equipment?

  Yes

  No

  N/A

Measurement Equipment Calibration Program

• 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.)

  Yes

  No

  N/A

• Are records of calibration checks and inspections maintained in a readily retrievable manner?

  Yes

  No

  N/A

Equipment Qualification Program

• Verify that all pieces of equipment used in production, packaging, and quality assurance are capable of producing valid results.

  Yes

  No

  N/A

• When computers are used to automate production or quality testing, have the computer and software been validated?

  Yes

  No

  N/A

• Have on-site tests of successive production runs or tests been used to qualify equipment?

  Yes

  No

  N/A

• Were tests repeated a sufficient number of times to ensure reliable results?

  Yes

  No

  N/A

• 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

• Have performance characteristics been identified for each piece of equipment? (May be provided by the manufacturer, but must be verified under typical operations conditions.)

  Yes

  No

  N/A

• Have operating limits and tolerances for performance been established from performance characteristics?

  Yes

  No

  N/A

Material/Component Specification and Purchasing Control

• Although purchasing is not specifically addressed in the current GMP regulation, incumbent upon user of components and materials to ensure quality of product, material or component.

  Yes

  No

  N/A

• Has each supplier/vendor of material or component been inspected/audited for proper manufacturing controls? (Review suppliers and audits and enter names, material supplied, and date last audited in notebook.)

  Yes

  No

  N/A

Material/Component Receipt, Inspection, Sampling, and Laboratory Testing

• Does the facility have current written procedures for acceptance/rejections of drug products, containers, closures, labeling and packaging materials?

  Yes

  No

  N/A

• 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

• Does inspection start with visual examination of each shipping container for appropriate labeling, signs of damage, or contamination?

  Yes

  No

  N/A

• 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

• Is the sampling technique written and followed for each type of sample collected?

  Yes

  No

  N/A

• Is the quantity of sample collected sufficient for analysis and reserve in case retesting or verification is required?

  Yes

  No

  N/A

• Verify that the following steps are included in written procedures unless more specific procedures are followed:

  Yes

  No

  N/A

• Containers are cleaned before samples are removed.

  Yes

  No

  N/A

• Stratified samples are not composited for analysis.

  Yes

  No

  N/A

• Containers from which samples have been taken are so marked indicating date and approximate amount taken.

  Yes

  No

  N/A

• Each sample container is clearly identified by material or component name, lot number, date sample taken, name of person taking sample, and original container identification.

  Yes

  No

  N/A

• 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

• If a Certificate of Analysis is not accepted for a lot of material, then additional testing is conducted by a written protocol to determine suitability for purpose.

  Yes

  No

  N/A

• Microbiological testing is conducted where appropriate.

  Yes

  No

  N/A

Material Component Storage and Handling

• Verify that materials and components are stored and handled in a way that prevents contamination, mix-ups, and errors.

  Yes

  No

  N/A

• Are incoming material and components quarantined until approved for use?

  Yes

  No

  N/A

• Are all materials handled in such a way to prevent contamination?

  Yes

  No

  N/A

• Are all materials stored off the floor?

  Yes

  No

  N/A

• Are materials spaced to allow for cleaning and inspection?

  Yes

  No

  N/A

• 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

• Are rejected components, material, and containers quarantined and clearly marked to prevent their use?

  Yes

  No

  N/A

Inventory Control Program

• Are inventory control procedures written?

  Yes

  No

  N/A

• Does the program identify destruction dates for obsolete or out-dated materials, components, and packaging materials?

  Yes

  No

  N/A

• Is stock rotated to ensure that the oldest approved product or material is used first?

  Yes

  No

  N/A

• 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

Vendor (Supplier) Control Program

• Are vendors periodically inspected according to a written procedure?

  Yes

  No

  N/A

• Is the procedure for confirming vendor test results written and followed?

  Yes

  No

  N/A

Material/Component/Label Verification, Storage, and Handling

• Do written procedures identify storage time beyond which components, containers, and closures must be reexamined before use?

  Yes

  No

  N/A

• Is release of retested material clearly identified for use?

  Yes

  No

  N/A

• Are retesting information supplements originally obtained?

  Yes

  No

  N/A

• Do written procedures identify steps in the dispensing of material for production?

  Yes

  No

  N/A

• Do these procedures include (1) release by QC, (2) Documentation of correct weight or measure, and (3) Proper identification of containers?

  Yes

  No

  N/A

• Does a second person observe weighing/measuring/dispensing and verify accuracy with a second signature?

  Yes

  No

  N/A

• Is the addition of each component documented by the person adding the material during manufacturing?

  Yes

  No

  N/A

• Does a second person observe each addition of material and document verification with a second signature?

  Yes

  No

  N/A

• Does a written procedure specify who is authorized to issue labels?

  Yes

  No

  N/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

• Do written procedures call for destruction of excess labeling on which lot or control numbers have been stamped or imprinted?

  Yes

  No

  N/A

Equipment/Line/Area Cleaning, Preparation, and Clearance

• 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

• Do written procedures detail any disconnection and reassembly required to verify readiness for use?

  Yes

  No

  N/A

Operational Process Validation and Production Change Order Control

• Have production procedures been validated? (Review selected procedures for validation documentation. Adequate?)

  Yes

  No

  N/A

• Does the process control address all issues to ensure identity, strength, quality, and purity of product?

  Yes

  No

  N/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

• Are all weighing and measuring preformed by one qualified person and observed by a second person?

  Yes

  No

  N/A

• Have records indicated preceding policy been followed by presence of two signatures?

  Yes

  No

  N/A

• Are actual yields calculated at the conclusion of appropriate phases of the operation and at the end of the process?

  Yes

  No

  N/A

• Are calculations performed by one person? Is there independent verification by a second person?

  Yes

  No

  N/A

In-Process Inspection, Sampling, and Laboratory Control

• 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

• 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

• 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

Reprocessing/Disposition of Materials

• Do written procedures identify steps for reprocessing batches?

  Yes

  No

  N/A

• Are quality control review and approval required for any and all reprocessing of material?

  Yes

  No

  N/A

• Does testing confirm that reprocessed batches conform to established specification?

  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

Finished Product Verification, Storage, and Handling

• Do write procedures indicate how and who verifies that correct containers and packages are used for finished product during the finishing operation?

  Yes

  No

  N/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

• Are expiration dates stamped or imprinted on labels?

  Yes

  No

  N/A

• Are expiration dates related to any storage conditions stated on the label?

  Yes

  No

  N/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

• Is finished product stored under appropriate conditions of temperature, humidity, light, etc.

  Yes

  No

  N/A

Finished Product Inspection, Sampling, Testing, and Release for Distribution

• 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

• Are written sampling and testing procedures and acceptance criteria available for each product to ensure conformance to finished product specifications?

  Yes

  No

  N/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

• Are sterility and pyrogen testing performed as required?

  Yes

  No

  N/A

• Are specific tests for foreign particles or abrasives included for any ophthalmic ointments?

  Yes

  No

  N/A

• Do controlled release or sustained release products include tests to determine conformance to release time specification?

  Yes

  No

  N/A

Distribution Controls

• Does a written procedure manage stocks to ensure that oldest approved product is sold first?

  Yes

  No

  N/A

• Are deviations to the policy above documented?

  Yes

  No

  N/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

Marketing Controls

• The current regulation does not address marketing controls per se except that all finished products must meet their specifications.

  Yes

  No

  N/A

Complaint Handling and Customer Satisfaction Program

• Are complaints, whether received in oral or written form, documented in writing and retained in a designated file?

  Yes

  No

  N/A

• Are complaints reviewed on a timely basis by the Quality Control Unit?

  Yes

  No

  N/A

• Is the action taken in response to each complaint documented?

  Yes

  No

  N/A

• Are decisions not to investigate a complaint also documented and the name of the responsible person documented?

  Yes

  No

  N/A

• 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

• Final Notes

• Sign off

  Sign