What is the IQ OQ PQ validation protocol?

 

Process Validation IQ, OQ, and PQ is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical device.

IQ, OQ, and PQ process validation are sequential activities that manufacturers carry out to validate their manufacturing processes. IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely. It is also to demonstrate that the manufacturing process under normal operating conditions will consistently produce conforming products.


IZiel works with your team to assist you to complete all the following process validation activities

  • ·        Process Validation Master Plan (PVMP)
  • ·         Process Characterization
  • ·         Equipment Installation and Qualification (IQ)
  • ·         Operational Qualification (OQ) – 
  • ·         Performance Qualification (PQ)
  • ·         Test Method Development (TMD) & Validation (TMV)


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