Pharma checklist for audit

Pre-Audit Preparation

Review all relevant regulatory guidelines and requirements

Ensure all necessary documentation is up to date and organized

Schedule meetings with key stakeholders to discuss audit process

Facility Inspection

Check cleanliness and organization of all areas, including production, storage, and laboratory spaces

Review equipment maintenance and calibration records

Confirm proper storage and handling of raw materials and finished products

Quality Control

Verify testing procedures and documentation are in compliance with regulations

Review batch records for accuracy and completeness

Check for any deviations or non-conformities and ensure proper corrective actions have been taken

Conduct a review of stability testing data to ensure product quality over time

Verify that all equipment used in the quality control process is calibrated and maintained according to manufacturer guidelines

Perform a review of the training records for quality control personnel to ensure they are adequately trained and qualified for their roles

Evaluate the effectiveness of the quality control system by reviewing trends in quality metrics and performance indicators

Verify that all raw materials and components used in production have undergone appropriate testing and inspection before use

Conduct a review of the validation and qualification processes for analytical methods used in quality control to ensure accuracy and reliability of results

Documentation

Ensure all SOPs are current and followed by staff

Review training records for all personnel involved in manufacturing and testing

Check for proper labeling and documentation of all products

Supplier Audit

Verify that all suppliers meet necessary quality standards

Review supplier qualification and monitoring processes

Check for any recent supplier audits and follow-up on any issues found

Post-Audit Follow-Up

Compile audit findings and recommendations

Schedule follow-up meetings with key stakeholders to discuss findings

Develop and implement action plan to address any non-conformities or areas for improvement.