Auditing of vendors and production department

Auditing of vendors and production department

• 1.
  AUDITING OF VENDORSAND PRODUCTION DEPARTMENT PRESENTED BY SHREYASH P. CHAUDHARI M.PHARM QUALITY ASSURANCE, 2ND SEM SUBJECT AUDITS AND REGULATORY COMPLIANCE DR. RAJENDRA GODE COLLEGE OF PHARMACY, MALKAPUR
• 2.
  C O NT E N T S • BULK PHARMACEUTICAL CHEMICALS AND PACKAGING MATERIAL VENDOR AUDIT • WAREHOUSE AND WEIGHING • DRY PRODUCTION :  GRANULATION  TABLETING  COATING  CAPSULES  STERILE PRODUCTION AND PACKAGING
• 3.
  DEFINATION • VENDOR AUDIT AVENDOR AUDIT IS A VEHICLE USED BY PHARMACEUTICAL COMPANIES, AND OTHER LARGE COMPANIES AS WELL, TO INSPECT AND EVALUATE A VENDOR'S QUALITY MANAGEMENT SYSTEM, AS WELLAS ITS PRACTICES, PRODUCTS, AND DOCUMENTATION TO REDUCE COST AND IMPROVE QUALITY.
• 4.
  BULK PHARMACEUTICAL VENDORAUDIT Manufacture of medicinal products and the active pharmaceutical ingredients (apis), bulk pharmaceutical ingredients (bpis) used as starting materials in the production of these products is subject to strict good manufacturing practice regulations that are designed to ensure their quality, safety and efficacy. This ensures that patients worldwide and at any time can have confidence in the quality, safety and efficacy of medicines.
• 5.
  PACKAGING MATERIAL VENDORAUDIT Packaging materials: any material employed in the packaging of a medicinal product, excluding any other packaging used for transportation or shipment.
• 6.
  WAREHOUSE AND WEIGHING •WHAT IS A WAREHOUSE? PLACE WHERE GOODS ARE KEPT IS CALLED –WAREHOUSE Warehousing is a set of activities that are involved in receiving and storing of goods and preparing them for reshipment.
• 7.
  WAREHOUSE CHECKLIST FOR AUDIT •RECEIVING • PRODUCT/INVENTORY ORDER • SHIPPING • STORAGING • MATERIAL HANDLING EQUIPMENT • WAREHOUSE LAYOUT • HOUSEKEEPING • ACCIDENT PREVENTION • SAFETY • PERSONNELS
• 8.
  WEIGHING WEIGHING MEANS – TOFIND OUT HOW HEAVY THE MATERIAL (TO BE WEIGHED IS) BY TYPICALLY USING SCALES.
• 9.
  AUDIT FOR DRYPRODUCTS  Premises:- • Design & layout of facilities • Plant safety & security • Sanitation  Personnel:- • Hygiene • Staff qualification • Staff training  Validation:- • Validation of new master formula • Validation of equipment and instrument  Documentation/records:- • Labels • Process documents • Sop’s  Samples  Stability study  Drug recall  Annual product report
• 10.
  FOR STERILE PRODUCTS:- Manufacturing area i. Equipment ii. Instrument calibration iii. Raw materials  Purified and water for injection  Sterilizer/oven loading room  Environmental monitoring  Aseptic batching area  Filling room i. Sanitization of sterile area ii. Inspection iii. Terminal sterilization iv. Packaging
• 11.
  FOR CAPSULE • Manufacturing •Equipment • Instrument calibration • Packaging • Packaging materials • Packaging operations • Labels and labelling operation • Reprocessing • Finished product control • Warehousing/distribution • Environment, health and safety
• 12.
  AUDITING OF GRANULATION