GMP Audit Checklist Pharma

Use the GMP Audit Checklist Pharma to uphold pharmaceutical industry standards, covering plant safety and security, audit programs, job training, and more.

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GMP Audit Checklist Pharma

4.1 Equipment Design And Placement

4.2 Equipment Identification

4.3 Equipment Maintenance & Cleaning

4.4 Measurement Equipment Calibration Program

4.5 Equipment Qualification Program

5.1 Material/Component Specification And Purchasing Control

5.2 Material/Component Receipt, Inspection, Sampling, And Laboratory Testing

11. Is at least one test conducted to confirm the identity of a raw material (bulk chemical or pharmaceutical) when a Certificate of Analysis is provided by the supplier and accepted by QA, as specified in §211.84(d)(1)(2), unless more specific procedures are followed?

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5.3 Material Component Storage And Handling

5.4 Inventory Control Program

5.5 Vendor (Supplier) Control Program

6.1 Material/Component/Label Verification, Storage, And Handling

6.2 Equipment/Line/Area Cleaning, Preparation, And Clearance

6.3 Operational Process Validation And Production Change Order Control

6.4 In-Process Inspection, Sampling, And Laboratory Control

6.5 Reprocessing/Disposition Of Materials

7.1 Finished Product Verification, Storage, And Handling

7.2 Finished Product Inspection, Sampling, Testing, And Release For Distribution

7.3 Distribution Controls

7.4 Marketing Controls

7.5 Complaint Handling And Customer Satisfaction Program

1.0 General Controls

1.1 Organizational & Management Responsibilities

1.2 Document Control Program

1.3 Employee Orientation, Quality Awareness, And Job Training

9. §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?

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1.4 Plant Safety And SecurityÂ

1.5 Internal Quality/GMP Audit Program

1.6 Quality Cost Program

2.0 Design Control

3.1 Facility Design And Layout

3.2 Environmental Control Program

3.3 Facility Maintenance And Good Housekeeping Program

3.4 Outside Contractor Control Program

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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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GMP Audit Checklist Pharma

Use the GMP Audit Checklist Pharma to uphold pharmaceutical industry standards, covering plant safety and security, audit programs, job training, and more.

1. §211.63 Is all equipment used to manufacture, process, or hold a drug product of appropriate design and size for its intended use?

2. Are the following pieces of equipment suitable for their purpose? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers

3. Are the following pieces of equipment suitable in their size/capacity? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers

4. Are the following pieces of equipment suitable in their design? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers

5. Are the locations in the facility of the following pieces of equipment acceptable? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers

6. Are the following pieces of equipment properly installed? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers

7. Is there adequate space for the following pieces of equipment? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers

8. §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?

9. §211.65(b) Are design and operating precautions taken to ensure that lubricants, coolants, or other operating substances do NOT come into contact with drug components or finished products?

10. §211.72 Are fiber-releasing filters NOT used in the production of injectable products?

11. § 211.72 Are asbestos filters NOT used in the production of products?

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

13. Is equipment cleaned promptly after use?

14. Is idle equipment stored in a designated area?

15. §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?

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

17. Does the cleaning procedure or startup procedure ensure that the equipment is systematically and thoroughly cleaned?

1. §211.105 Are all pieces of equipment clearly identified with easily visible markings?

2. §211.105(b) Are all pieces of equipment also marked with an identification number that corresponds with an entry in an equipment log?

3. Does each piece of equipment have written instructions for maintenance that include a schedule for maintenance?

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

1. §211.67(b) Are written procedures established for the cleaning and maintenance of equipment and utensils?

2. Are these procedures followed?

3. §211.67(b)(1) Does a written procedure assign responsibility for the cleaning and maintenance of equipment?

4. §211.67(b)(2) Has a written schedule been established and is it followed for the maintenance and cleaning of equipment?

5. Has the cleaning procedure been properly validated?

6. §211.67(b)(2) If appropriate, is the equipment sanitized using a procedure written for this task?

7. §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?

8. §211.67(b)(3) Does the procedure specify the removal or obliteration of production batch information from each piece of equipment during its cleaning?

9. Is equipment cleaned promptly after use?

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

11. §211.67(b)(5) Is clean equipment adequately protected against contamination prior to use?

12. §211.67(b) Is equipment inspected immediately prior to use?

13. §211.67(c) Are written records maintained on equipment cleaning, sanitizing, and maintenance on or near each piece of equipment?

1. §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 a notebook with cross reference.)

2. §211.68(a Are records of calibration checks and inspections maintained in a readily retrievable manner?

1. §211.63 Are all pieces of equipment used in production, packaging, and quality assurance capable of producing valid results?

2. §211.68(a) When computers are used to automate production or quality testing, have the computer and software been validated?

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

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

5. §211.63 Is each piece of equipment identified to its minimum and maximum capacities and minimum and maximum operating speeds for valid results?

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

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

1. 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 a notebook.)

1. §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.)

2. §211.80(d) Is each lot within each shipment of material or components assigned a distinctive code so material or components can be traced through manufacturing and distribution?

3. §211.82(a) Does inspection start with a visual examination of each shipping container for appropriate labeling, signs of damage, or contamination?

4. §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?

5. §211.160(b) Is the sampling technique written and followed for each type of sample collected?

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

7. Are containers cleaned before samples are removed, as specified in §211.84(c)(2), unless more specific procedures are followed?

8. Are stratified samples not composited for analysis, as specified in §211.84(c)(4), unless more specific procedures are followed?

9. Are containers from which samples have been taken marked with the date and the approximate amount taken, as specified in §211.84(c)(5), unless more specific procedures are followed?

10. Is each sample container clearly identified by material or component name, lot number, date of sample taken, name of the person taking the sample, and original container identification, unless more specific procedures are followed?

11. Is at least one test conducted to confirm the identity of a raw material (bulk chemical or pharmaceutical) when a Certificate of Analysis is provided by the supplier and accepted by QA, as specified in §211.84(d)(1)(2), unless more specific procedures are followed?

12. If a Certificate of Analysis is not accepted for a lot of material, is additional testing conducted by a written protocol to determine suitability for the purpose, unless more specific procedures are followed?

13. Is microbiological testing conducted where appropriate, as specified in §211.84(d)(6), unless more specific procedures are followed?

1. Are incoming materials and components quarantined until approved for use, as required by §211.42(b), to prevent contamination, mixups, and errors, unless more specific procedures are followed?

2. Are all materials handled in a way that prevents contamination, as required to prevent mixups and errors?

3. Are all materials stored off the floor to prevent contamination, mixups, and errors, as required?

4. Are materials spaced to allow for cleaning and inspection, ensuring prevention of contamination, mixups, and errors?

5. Are labels for different products, strengths, dosage forms, etc., stored separately with suitable identification, as required by §211.122(d), to prevent contamination, mixups, and errors?

6. Is access to the label storage area restricted to authorized personnel to prevent contamination, mixups, and errors?

7. Are rejected components, materials, and containers quarantined and clearly marked to prevent their use, as required by §211.89, to prevent contamination, mixups, and errors?

1. §211.142 Are inventory control procedures written?

2. Does the program identify destruction dates for obsolete or outdated materials, components, and packaging materials?

3. §211.150(a) Is stock rotated to ensure that the oldest approved product or material is used first?

4. §211.184(e) Is the destruction of materials documented in a way that clearly identifies the material destroyed and the date on which the destruction took place?

1. Are vendors periodically inspected according to a written procedure?

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

1. §211.87 Do written procedures identify storage time beyond which components, containers, and closures must be reexamined before use?

2. §211.87 Is the release of retested material clearly identified for use?

3. Are retesting information supplements originally obtained?

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

5. Are release procedures conducted by QC included in these procedures?

6. Do these procedures include documentation of correct weight or measure?

7. Do these procedures include proper identification of containers?

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