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Process Validation

Process Validation

We have extensive experience in implementing a robust 3 stage Process Validation life cycle based on the 2011 FDA guidance document on Process Validation. This includes development of policies and procedures as well as execution of process design, process qualification and continued process.

Verification programs for various companies. We have several accomplishments in the area of helping companies move through the various phases of commercialization of products.

Process validation involves appropriate documentation throughout all phases of the validation process. The FDA expects a three-stage approach with commercial distribution occurring between the second and third stages.

  • 1. Process includes creation, development and execution of process qualification and validation document.
  • 2. Development reports.
  • 3. Development of scientifically justified validation and sampling plans.
  • 4. Continued process verification. Development of statistically justified in-process and finished product sampling strategies.
Process Validation