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What Are the Differences in the New Process Validation Guidances?

  
  
  
  Enterey Process Validation Differences

 
What should you be doing differently?
  

There has been an FDA industry paradigm shift, with which you will need to align. Provided below is an easy reference table pointing out key elements of FDA’s Guidance for Industry Process Validation: General Principles and Practices (January 2011), some of the differences in the new guidance, and the areas of focus for FDA during their next inspection of your facility as it pertains to process validation.

Take a look at how these modifications could influence today’s current practices.

FDA Guidance for Industry
Process Validation: General Principles and Practices (2011)

Scope includes entire Product and Process Lifecycle

Decisions are based on Sound Science and Risk Management

3-Staged Approach to Process Validation:

1)       Process Design

2)       Process Qualification (PQ)

3)       Continued Process Verification

Emphasis on Process Design – Process design is dependent on process knowledge and understanding obtained; testing to failure is not required or expected; studies are conducted with sound scientific methods and principles, including good documentation practices

Process Qualification (PQ) differs from 1987 guidance - Process Performance Qualification (PPQ) is milestone in product lifecycle prior to commercial distribution; PPQ  is based on sound science, product and process understanding, and demonstrable control

Emphasis on Continued Process Verification and Process Control – Process knowledge and understanding is basis for approach to process control; ongoing program must be established to collect and analyze product and process data, trends, quality of incoming materials, in-process material, and finished products

Statistics – Statistician or person with adequate training in statistical process control to develop data collection plan for Continued Process Verification, statistical methods and procedures to measure and evaluate process capability, intra-batch and inter-batch variation is recommended

Revalidation and Retrospective Process Validation has been eliminated with Continued Process Verification

There is no magic number of required lots or runs in PPQ;  a documented justification and rationale that assurance is achieved and the process is in a state of control is stated in the PPQ Protocol Execution and Report

Level of PQ effort, documentation, testing, degree of control over attributes or parameters during Continued Process Verification, etc. are all commensurate to the level of risk to the process or product

Publishe by: Jim Anthony, Enterey | Director

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