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As a part of validation activities, qualification is an essential requirement for cGMP plants to manufacture pharmaceuticals or medical devices when the plants or their systems are newly built or renovated. It consists of DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). When a validation project is planned, it is much easier for validation engineers to prepare the work.

  • Preparation & Submission of Master Validation Plan
  • Validation Protocols: DQ, IQ, OQ, PQ
  • cGMP Validation Protocols as per U.S. FDA and U.K.MHRA
  • Documentation as per required approvals