W.H.O. — cGMP MINIMUM DOCUMENT CHECK LIST —
- SITE MASTER FILE
- AIR QUALITY MANNUALS.
- WATER QUALITY MANNUALS
- ALL PROCESS RELATED SOP
- MARKET COMPLAIN RECORDS
- CALIBERATION RECORDS.
- PROCESS VALIDATION
- ANALYTICAL METHOD VALIDATION
- CLEANING METHOD VALIDATION
- EQUIPMENT QUALIFICATIONS –DQ, IQ, OQ & PQ
- INTERNAL QUALITY AUDITS REPORTS
- MEDICAL CHECK-UP RECORDS OF EMPLOYES
- MASTER FORMULA RECORDS
- BATCH MANUFACTURING RECORDS
- BATCH PACKING RECORDS
- LIST OF COMPETENT TECHNICAL STAFF
- LATEST FDA APPROVED PLAN
- SHORT TERM LONG TERM & PHOTOSTABILITY (ZONE WISE )
- APPROVED VENDOR LISTS
- VENDORS EVALUATION RECORDS
- EMPLOYEE TRAINING RECORDS
- PEST CONTROL, PREMISES MAINTENANCE RECORD (SANITATION, CLEANING)
- CLOTH WASHING & LAUNDERING RECORDS
- PREVENTIVE & BREAKDOWN MAINTENANCE RECORDS.
- ANNUAL PRODUCT QUALTIY REVIEW OR APQR
- GROWTH PROMOTION TEST EVALUATION.
- PRESERVATIVE EFFICACY TESTING.
- RISK ANALYSIS & CRITICAL CONTROL POINT DOCUMENTATION.
- STANDARD TESTING PROCEDURE & SPECIFICATIONS FOR RAW MATERIALS, PACKING MATERIALS , INTERMEDIATES , & FINISHED PRODUCT.
CERTIFICATION FOR PHARMACEUTICALS INDUSTRIES —
- INDIAN GMP (Schedule M) STATUTORY FROM JUNE 1988 IN INDIA.
- INTERNATIONAL ORGANIZATION FOR STANDARDS (ISO 9001 & 14001)
- WORLD HEALTH ORGANIZATION (ITS GMP)
- THERAPEUTIC GOODS ADMINISTERATION (TGA), AUSTRALIA
- MEDICINES AND HEALTH CARE PRODUCTS REGURATORY AGENCY (MHRA), UNITED KINGDOM
- MEDICINE CONTROL COUNCIL (MCC), SOUTH AFRICA
- cGMP CERTIFICATION FROM US FOOD AND DRUG ADMINISTRATION (USFDA)
- INTERNATIONAL CONFERENCE ON HARMINIZATION (ICH), USA, EUROPE, & JAPAN.
- CERTIFICATES OF SUITABILITY (COS), EUROPE.