Audit Checklist for QA Department: here is the Audit Checklist for QA Department. You can find the best checking point for QA [Quality Assurance] Department in pharmaceutical Company-
- Annual product review/Product Quality Review reports
- Batch Document Archiving /Retrieval system/Disposal records
- CAPA [Corrective And Preventive Action]
- Calibration Records of balance, equipment’s, machine etc.
- Change Control
- Destruction of samples & Chemicals reports
- Deviation Management
- Drug Master file of existing & new products
- Failure Investigation
- Finished products Released records
Comprehensive QC Department Audit Checklist
- GMP/Self-Inspection audit reports
- Job Description
- Incineration by third party Records
- List of finished products, Raw materials & packing materials
- Logbook maintaining & Issuance Records
- Label Control Procedure
- Market Complaint Investigation Report
- Machine/Equipment Qualification status records with index
- Organogram (Factory)
- Previous Self Inspection/Internal Audit Report
- Process Validation Protocols & reports
- Quality Manual
- Risk Management
- Retention Sample Management
- Rework/Re-process records
- Reagent Management records with index
- Recall Procedure
- Retention samples records with index
- Records of market return Goods destruction
- Site Mater File (SMF)
- Source approval procedure and its records
- Standardization of volumetric solution records
- Stability studies report of both accelerated and long term
- Storage condition of RM, PM, intermediate, bulk & finished products
- Specimen signature list
- Technology transfer records
- Validation Master Plan (VMP)
- Vendor/ Supplier Audit reports
- Write off & Disposal records of Non-conforming/Rejected materials & products
- Yearly Training Calendar and its records for both on Job & GMP
- SOP Index
- SOP for
- CAPA
- Change Control
- Deviation Management
- Hold Time Study
- IPC[In-Process Control] Instruments
- Job Description
- Labelling & Label Control
- Market Complaint Handling
- Quality Manual
- Quality Risk Management[QRM]
- Recall Procedure
- Site Master File
- Training Manual
- Waste Disposal
This all about the Audit Checklist for QA Department but not limited to.