Process validation

Process validation

When it comes to process validation, inspectors have the authority and responsibility to inspect and evaluate your process validation approach. To ensure that your process validation is effective the following conditions need to be in place:

  • Quality, safety, and efficacy are designed or built into the product
  • Quality cannot be adequately assured merely by in-process and finished-product inspection or testing
  • Each step of a manufacturing process is controlled to assure that the finished product meets all quality attributes including specifications

Process validation involves a series of activities taking place over the lifecycle of the product and process:

  • Phase 1 – Process Design: the commercial manufacturing process is defined during the phase based on knowledge gained through development and scale-up activities
  • Phase 2 – Process Qualification: during this phase, the process design is evaluated to determine if the process is capable of reproducible commercial production
  • Phase 3 – Continued Process Verification: ongoing assurance is gained during routine production that the process remains in a state of control

It can be stated that a successful Validation program depends upon information and knowledge from the product and process development. Manufacturers should:

  • Understand the sources of variation
  • Detect the presence and degree of variation
  • Understand the impact of variation on the process and ultimately on product attributes
  • Control the variation in a manner commensurate with risk it represents to the process and product

Rescop can provide Process Validation experts, who understand the demands and regulations which are required. Next to Process validation, our GxP consultants are able to provide guidance and expertise for your method validation and cleaning validation. Please contact use to discuss your needs and develop a clear path forward.


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