A brief understanding of the FDA General Principles on Process Validation

A brief understanding of the FDA General Principles on Process Validation

Key Takeaway:

The FDA has issued vastly improved and expanded general principles on process validation in January 2011. These build substantially on the previous issue of 1987.

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

Being a regulatory body, the FDA has assigned to itself the task of issuing guidelines to the industry on the principles of process validation (PV). FDA general principles on process validation, the latest of which were issued in 2011 replacing those of 1987, are aimed at facilitating:

  • Modern manufacturing principles
  • Sound science
  • Risk assessment and mitigation
  • Process improvement
  • Innovation

Basis to the FDA general principles

FDA general principles on process validation are founded on the understanding of the following conditions:

fdaGeneralPrinciplesOnProcessValidation

How should product quality be ensured according to the FDA general principles on process validation?

FDA general principles on process validation of 2011 lay clear emphasis on the requirement of Quality. Accordingly, a product should show quality performance consistently in every batch and every unit.

What about PV?

Likewise, the FDA general principles on process validation tie process validation to the product lifecycle approach. In a nutshell, the lifecycle approach to PV binds product and process development to the commercial manufacturing process, and requires the process to be maintained in a state of control during routine production. The FDA believes that:

  • Validation is a journey, not a destination
  • Commercial production throws up more and more knowledge of PV
  • In order to comprehend sources of variability and achieve an understanding of process; there is a need for comprehensive process design
  • Risk management has to be built into process validation

The Three Stages of PV

According to the FDA general principles on process validation, Process Validation consists of three stages:

fdaGeneralPrinciplesOnProcessValidation

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