Before beginning an on-site audit:
- Make a plan.
- Review previous audits and note any potential problem areas or items flagged for corrective action in a previous audit.
- Learn about the type of product produced here and how it is arranged by personnel and function if unfamiliar with the facility.
Following the WHO-GMP Document Check List helps you understand the requirement during visits to premises.
Document Check List for visitors
- Site Master File.
- Air Quality Manuals.
- Water Quality Manual.
- All process-related SOPs.
- Standard Testing Procedures (STPs) and Specifications for Raw Material, Packing Material, Intermediate, and Finished Product.
- Market Complaints Record.
- Calibration Record.
- Process Validations report for 3 Batches.
- Analytical Method Validations.
- Cleaning Method Validations.
- DQ/IQ/OQ/ PQ.
- Internal Quality Audit Reports.
- Medical Checkup Record of Employee.
- Master Formula Records.
- Batch Manufacturing Records.
- Batch Packing Records.
- List of Machine and Equipment for Production and QA/QC(QU- Quality Unit).
- List of Competent Technical Staff.
- Latest FDA Approved Plan.
- Short Term, Long Term and Photostability. (Zone wise.)
- Stability study evaluation (accelerated and real-time) for three batches, including batch size, batch number, product name, expiry dates, stability study condition (accelerated/real-time), drug name, and so on (as per Format-A) (At least a six-month timeframe for Accelerated Stability data and a year for other data.) At the time of initial submission, real-time stability data must be submitted.)
- Approved Vendor List and Vendor Evaluation Record.
- Employee Training Record.
- Pest Control, Premises Maintenance Record (Sanitation, Cleaning ).
- Cloth Washing and Laundering Record.
- Preventative and Break Down Maintenance Record.
- All other Records as per WHO GMP Guidelines.
- Must include Annual product quality review (APQR) Growth promotion test evaluation.
- Preservative efficacy testing.
- Risk analysis and critical control point documentation
- Rule 158B of the Drugs and Cosmetic Rules, 1945, requires proof of safety and effectiveness.
- last inspection Date
Format-B: Product summary sheet
Conclusion:
A Good Manufacturing Practice audit checklist is one of the best effective methods available for importers to determine their supplier’s WHO-GMP inspection readiness. However, creating a WHO-GMP Document Check List is not a simple operation. It can take a long time to create, execute, and maintain a complete checklist.