pharmaceutical internal udit checklist for all department in detail

Quality Control Department

Review of standard operating procedures (SOPs) for accuracy and compliance with regulations

Validation of testing equipment and methods

Verification of raw material and finished product testing

Review of batch records for completeness and accuracy

Investigation of deviations and non-conformances

Quality Assurance Department

Review of batch release process

Evaluation of change control procedures

Assessment of training records for staff

Review of complaints and recalls

Audit of vendor qualification process

Verification of compliance with current Good Manufacturing Practices (cGMP)

Review of internal audit findings and corrective actions

Assessment of product stability testing procedures

Evaluation of validation protocols and reports

Monitoring of deviations and investigations process

Examination of quality agreements with third-party manufacturers or suppliers

Production Department

Verification of production batch records

Inspection of manufacturing equipment for cleanliness and maintenance

Review of cleaning procedures for equipment and facilities

Assessment of in-process controls

Evaluation of batch reconciliation process

Research and Development Department

Review of research protocols and documentation

Assessment of data integrity and accuracy

Verification of sample storage and handling procedures

Evaluation of stability testing protocols

Audit of technology transfer processes

Regulatory Affairs Department

Review of product registration and submission files

Assessment of regulatory compliance and updates

Evaluation of labeling and packaging changes

Audit of regulatory agency communications

Verification of pharmacovigilance processes

Supply Chain Department

Inspection of storage conditions for raw materials and finished products

Assessment of transportation and distribution processes

Review of inventory management procedures

Audit of supplier and contract manufacturer agreements

Evaluation of cold chain management processes

Documentation Department

Review of document control procedures

Assessment of document retention and archiving processes

Verification of document version control

Audit of electronic document management systems

Evaluation of document review and approval processes

Overall

Review of overall compliance with Good Manufacturing Practices (GMP)

Assessment of risk management processes

Audit of internal audit program

Evaluation of corrective and preventive action processes

Verification of management review processes.