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supplier audit checklist regarding gmp

General Information

Supplier Name

Supplier Address

Date of Audit

Auditor Name

Supplier Contact Person

Documentation and Recordkeeping

Are all required GMP documents available and up to date?

Are standard operating procedures (SOPs) in place for all critical processes?

Are records of raw material testing and analysis available?

Are batch records maintained and easily accessible?

Are there procedures in place for documenting and investigating deviations or non-conformances?

Are quality control procedures documented and followed?

Facilities and Equipment

Is the supplier's facility clean and well-maintained?

Is there a pest control program in place?

Are the equipment and machinery used suitable for the process?

Are equipment maintenance logs available and up to date?

Is there a calibration program for critical equipment?

Raw Materials and Components

Are raw materials received with proper documentation and labeling?

Are incoming raw materials tested for quality and compliance?

Is there a system for segregating and controlling rejected or expired materials?

Are there procedures for traceability and recall of raw materials?

Manufacturing Process

Are there procedures in place for process validation and change control?

Is the manufacturing process well-documented and followed consistently?

Is there a system for controlling and recording in-process quality checks?

Are there procedures for cleaning and disinfection of equipment and facilities?

Is there a system for investigation and control of product deviations or failures?

Packaging and Labeling

Are packaging materials properly stored and controlled?

Is the packaging process validated and documented?

Are all required labels and product information included accurately?

Quality Control and Testing

Is there a designated quality control laboratory with appropriate equipment?

Are there qualified personnel responsible for quality control testing?

Are testing procedures and specifications documented and followed?

Are there procedures for handling and reporting of out-of-specification results?

Training and Personnel

Are personnel trained in GMP requirements and procedures?

Is there a training program in place, and are training records maintained?

Are personnel involved in critical processes adequately qualified and trained?

Corrective and Preventive Actions (CAPA)

Is there a system for documenting and addressing non-conformances?

Are corrective and preventive actions taken to address identified issues?

Are CAPAs tracked to completion, and is there evidence of effectiveness?

Audit Conclusion

Overall assessment of the supplier's compliance with GMP requirements.

Identification of any major or critical non-conformances.

Recommendations for improvement or areas of concern.

Follow-up actions or additional audits required.

Note: This checklist is a general guideline and can be customized as per the specific requirements of the manufacturing organization and its products.

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