According to the FDA’s new guidance on process validation which was published in 2011.

“Process validation is the collection and evaluation of data, from the process design stage throughout commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products”.

A fundamental principle of quality assurance is that quality cannot be adequately assured by only using in-process and finished product testing.

Quality, safety and efficacy must be designed and built into a product. Each step of a manufacturing process must be controlled to assure that the finished product meets all quality attributes including specifications.

The 3 Stages of Process Vaidation

In its guidance document on process validation, the FDA promotes a three stage validation process consisting of:

  • Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
  • Stage 2 – Process Validation: This is called Process Qualification in the current FDA Guidance. During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
  • Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

The European Medicines Agency, in its guidance “Guideline on process validation for finished products – information and data to be provided in regulatory submissions” published in February 2016 also advocates a similar approach.

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