WHO-GMP Document Check List for Visitors

Before beginning an on-site audit, the following Check List for Visitors points should be considered:

• Make a plan.
• Review previous audits and note any potential problem areas or items flagged for corrective action.
• Learn about the type of product produced here and how it is arranged by personnel and function if unfamiliar with the facility.

Using the WHO-GMP Document Checklist can help you understand the requirements during visits to the 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 Products.
• 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 Machines 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 an Annual product quality review (APQR) and 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 (GMP) audit checklist is one of the most effective methods available for importers to assess their supplier’s readiness for a WHO-GMP inspection. However, creating a WHO-GMP Document Checklist is not a simple task. It can take a long time to create, execute, and maintain a complete checklist.