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WHO-GMP Document Check List for Visitors

Before beginning an on-site audit:

  1. Make a plan.
  2. Review previous audits and note any potential problem areas or items flagged for corrective action in a previous audit.
  3. 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
Document Check List For stability testing

Format-B: Product summary sheet

 Product summary sheet for stability checklist


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.

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