Process Performance Qualification

 Process Performance Qualification (PPQ) is a stage of process validation in which the process design is evaluated to determine if it is capable of reproducing commercial manufacturing. During this phase, the facility and equipments are evaluated to confirm whether they are capable of providing desired output or not. ADB Consulting validates and verifies all utility systems and equipment to be built and installed properly and ensures that they operate within the intended and expected operating ranges.

PPQ is considered a significant milestone in the product lifecycle because the decision to deliver product to the market depends largely upon the successful completion of this stage. It focuses on three qualifications which include:

·         Installation qualification (IQ) verifies that your equipment or product has been delivered, installed and configured in accordance with the pre-determined specifications, statutory safety regulations, and industry standards.

 

·         Operational qualification (OQ) aims at testing the process parameters, and this validation stage ensures that the process is performing within the operating ranges under the appropriate operating principles.

 

·         Performance qualification (PQ) verifies whether the device or equipment function correctly and consistently for the intended application or not. The PQ also establishes evidence that the process will invariably produce acceptable products.


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