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audit checklist for pharmaceutical industry

1. Documentation Review

Verify the existence of a quality manual.

Evaluate standard operating procedures (SOPs) for compliance.

Check for up-to-date records of training and qualifications.

Review batch records for completeness and accuracy.

Ensure availability of manufacturing and testing protocols.

Here are some additional steps that can be included in the "Documentation Review" section of the audit checklist for the pharmaceutical industry

Verify the existence and accessibility of a document control system

Review change control documents for proper approval and implementation

Check for the availability of validation and qualification documents for equipment and processes

Assess the completeness of stability study records and reports

Evaluate deviation reports for proper investigation and resolution documentation

Ensure that all relevant regulatory submissions and approvals are on file

Review internal audit reports for findings and corrective actions taken

Verify the existence of risk management documentation and assessments

Assess quality agreements with third-party vendors for compliance

Check for the documentation of corrective and preventive actions (CAPA)

Review product specifications and ensure they are current and approved

Ensure that all relevant environmental monitoring records are available and up to date

2. Facility and Equipment Inspection

Inspect the cleanliness and organization of the manufacturing area.

Verify calibration records for critical equipment.

Check for proper maintenance logs of machinery.

Assess compliance with environmental controls (temperature, humidity).

Evaluate the sanitation and validation of cleaning processes.

3. Personnel Compliance

Review employee training records for GMP compliance.

Ensure personnel are wearing appropriate protective equipment.

Check for competency assessments of key staff.

Verify the existence of a hygiene program for employees.

4. Quality Control Processes

Evaluate the laboratory testing methods and validation.

Check the handling of raw materials and intermediates.

Verify stability and expiration date testing protocols.

Assess the procedures for handling non-conformance and deviations.

Review documentation for product release and disposition.

5. Safety and Risk Management

Inspect the implementation of a safety management system.

Check for risk assessments related to manufacturing processes.

Review incident reports and corrective actions taken.

Evaluate training on safety and emergency procedures.

Ensure compliance with hazardous material handling regulations.

6. Regulatory Compliance

Verify compliance with local and international regulations (FDA, EMA).

Review the status of any pending inspections or audits.

Ensure that any regulatory findings from previous audits have been addressed.

Check for the existence of a regulatory compliance program.

7. Continuous Improvement

Evaluate processes for capturing and analyzing quality metrics.

Review the implementation of CAPA (Corrective and Preventive Actions).

Check for employee feedback mechanisms and suggestion programs.

Assess the effectiveness of internal audits and management reviews.

8. Supply Chain Management

Verify supplier qualification and audit processes.

Evaluate the procedures for raw material sourcing and testing.

Check for documentation related to material traceability.

Review the logistics and distribution practices in compliance with regulations.

9. Product Recall Procedures

Review the recall plan and its effectiveness.

Check for traceability of products in the event of a recall.

Evaluate communication strategies for informing stakeholders.

Verify the training and readiness of staff for recall situations.

10. Final Review and Reporting

Summarize findings and observations from the audit.

Prepare a report detailing areas of non-compliance and strengths.

Discuss findings with key stakeholders and management.

Outline action items and timelines for addressing issues.

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