Commissioning And Qualification

Facility, Processing Equipments, Utility Equipment, QC instruments and Documentation and Qualification Pharmaceutical Industry Type:- Tablets, Capsules, Oral Liquids, Ointments, Vaccines, Insulin, Liquid Injection, Prefilled Syringes, Ampoule, Vial, LDPE Bottle (0.5 ml – 1000 ml), Eye Drops, Powder Injections, Betalactam, Non Betalactam, Anticancer, Hormonal

• Validation Master Plan (VMP)
• Site Master File (SMF)
• User Requirement Specifications
• System Impact Assessments
• Critical Component Assessments
• Design Qualification
• Factory Acceptance Test
• Site Acceptance Test
• Installation Qualification
  • Protocol and Report
• Operational Qualification
• Protocol and Report
• Performance Qualification Requalification
  • Protocol and Report
• Requalification
  • Protocol and Report