Pharmaceutical manufacturing audit checklist as per revised schedule M
Facility and Equipment
Quality Control
- Record all manufacturing processes accurately
- Include details such as equipment used, personnel involved, and critical control points
- Establish a schedule for testing raw materials and finished products
- Ensure tests are conducted according to approved methods
- Validate analytical methods for accuracy and reliability
- Document validation results and update as needed
- Ensure personnel have necessary qualifications and training
- Provide ongoing training to keep skills up to date
- Store reference standards in appropriate conditions
- Handle reference standards according to specified procedures
- Establish procedures for identifying and disposing of expired or damaged materials
- Document disposal activities for audit trail
- Establish a schedule for calibration and maintenance
- Ensure equipment is calibrated and maintained by qualified personnel
- Participate in external proficiency testing programs
- Analyze results and implement improvements as needed
- Analyze quality control data for trends over time
- Use trends to identify areas for improvement
- Investigate any deviations or non-conformances in quality control
- Implement corrective actions to prevent reoccurrence
- Implement corrective actions for immediate issues
- Implement preventive actions to avoid future problems
- Document quality control activities in batch records
- Include details such as test results, personnel involved, and any deviations
- Require approval of quality control test results by authorized personnel
- Document approvals for traceability
- Regularly review quality control procedures and specifications
- Update as needed based on new information or requirements
- Retain samples according to specified retention periods
- Store samples in appropriate conditions for future reference or testing
Documentation and Records
- Ensure all batch records are current and accurate with all necessary information recorded
- Verify that batch records are properly filled out and signed by authorized personnel
- Check that all finished products are correctly labeled with required information
- Ensure finished products are packaged appropriately to maintain product integrity
- Document any deviations from standard procedures and the corresponding corrective actions taken
- Ensure deviations are investigated, documented, and resolved in a timely manner
- Document any changes made to manufacturing processes and procedures
- Ensure changes are properly reviewed, approved, and documented before implementation
- Maintain records of training provided to personnel
- Document qualifications and competencies of personnel involved in manufacturing processes
- Record all complaints received and actions taken to address them
- Document any product recalls and the associated investigations and resolutions
- Keep records of equipment maintenance schedules and activities
- Document equipment calibration procedures and results
- Maintain records of cleaning and sanitation schedules
- Document cleaning procedures and verification activities
- Keep detailed specifications for all raw materials and finished products
- Ensure specifications are up-to-date and accessible to relevant personnel
- Record stability testing procedures and results for all products
- Document any deviations from expected stability results and the actions taken
- Document environmental monitoring procedures and results
- Ensure compliance with environmental monitoring requirements
- Maintain records of validation and qualification studies for processes and equipment
- Document validation protocols, results, and conclusions
- Record details of batch release and disposition processes
- Ensure all necessary approvals are obtained before releasing batches
- Document data integrity controls in place to ensure data accuracy and reliability
- Regularly review and update data integrity controls as needed
- Maintain records of vendor qualifications and audits
- Document any vendor audits conducted and the results
- Document change control procedures for implementing changes in processes or systems
- Ensure all changes are properly evaluated, approved, and documented
Use in Manifestly