WHO GMP AUDIT DOCUMENT CHECK LISTS

by

W.H.O. — cGMP MINIMUM DOCUMENT CHECK LIST —

  1. SITE MASTER FILE
  2. AIR QUALITY MANNUALS.
  3. WATER QUALITY MANNUALS
  4. ALL PROCESS RELATED SOP
  5. MARKET COMPLAIN RECORDS
  6. CALIBERATION RECORDS.
  7. PROCESS VALIDATION
  8. ANALYTICAL METHOD VALIDATION
  9. CLEANING METHOD VALIDATION
  10. EQUIPMENT QUALIFICATIONS –DQ, IQ, OQ & PQ
  11. INTERNAL QUALITY AUDITS REPORTS
  12. MEDICAL CHECK-UP RECORDS OF EMPLOYES
  13. MASTER FORMULA RECORDS
  14. BATCH MANUFACTURING RECORDS
  15. BATCH PACKING RECORDS
  16. LIST OF COMPETENT TECHNICAL STAFF
  17. LATEST FDA APPROVED PLAN
  18. SHORT TERM LONG TERM & PHOTOSTABILITY (ZONE WISE )
  19. APPROVED VENDOR LISTS
  20. VENDORS EVALUATION RECORDS
  21. EMPLOYEE TRAINING RECORDS
  22. PEST CONTROL, PREMISES MAINTENANCE RECORD (SANITATION, CLEANING)
  23. CLOTH WASHING & LAUNDERING RECORDS
  24. PREVENTIVE & BREAKDOWN MAINTENANCE RECORDS.
  25. ANNUAL PRODUCT QUALTIY REVIEW OR APQR
  26. GROWTH PROMOTION TEST EVALUATION.
  27. PRESERVATIVE EFFICACY TESTING.
  28. RISK ANALYSIS & CRITICAL CONTROL POINT DOCUMENTATION.
  29. STANDARD TESTING PROCEDURE & SPECIFICATIONS FOR RAW MATERIALS, PACKING MATERIALS , INTERMEDIATES , & FINISHED PRODUCT.

CERTIFICATION FOR PHARMACEUTICALS INDUSTRIES —

  1. INDIAN GMP (Schedule M) STATUTORY FROM JUNE 1988 IN INDIA.
  2. INTERNATIONAL ORGANIZATION FOR STANDARDS (ISO 9001 & 14001)
  3. WORLD HEALTH ORGANIZATION (ITS GMP)
  4. THERAPEUTIC GOODS ADMINISTERATION (TGA), AUSTRALIA
  5. MEDICINES AND HEALTH CARE PRODUCTS REGURATORY AGENCY (MHRA), UNITED KINGDOM
  6. MEDICINE CONTROL COUNCIL (MCC), SOUTH AFRICA
  7. cGMP CERTIFICATION FROM US FOOD AND DRUG ADMINISTRATION (USFDA)
  8. INTERNATIONAL CONFERENCE ON HARMINIZATION (ICH), USA, EUROPE, & JAPAN.
  9. CERTIFICATES OF SUITABILITY (COS), EUROPE.