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Monday, April 25, 2011

Process Validation documentation

Documentation guidelines for process validation , pharmaceutical process validation documentation

One of the important aspect of process validation is documentation of information gathered and learned during a process and utilizing that for assuring the efficacy of process and thus the validating the process, US FDA has published guidelines for process validation with respect to current good manufacturing practices guidelines(c gmp guidelines) on Jan 2011, the guidelines about documentation for process validation is as follows.

Documentation at each stage of the process validation lifecycle is essential for effective communication in complex, lengthy, and multidisciplinary projects. Documentation is important so that knowledge gained about a product and process is accessible and comprehensible to others involved in each stage of the lifecycle. Information transparency and accessibility are fundamental tenets of the scientific method. They are also essential to enabling organizational units responsible and accountable for the process to make informed, science-based decisions that ultimately support the release of a product to commerce.
The degree and type of documentation required by CGMP vary during the validation lifecycle. Documentation requirements are greatest during Stage 2 , process qualification, and Stage 3, continued process verification. Studies during these stages must conform to CGMPs and must be approved by the quality unit in accordance with the regulations (see 21 CFR 211.22 and 211.100). Viral and impurity clearance studies, even when performed at small scale, also require quality unit oversight.
CGMP documents for commercial manufacturing (i.e., the initial commercial master batch production and control record (§ 211.186) and supporting procedures) are key outputs of Stage 1, process design. We recommend that firms diagram the process flow for the full-scale process. Process flow diagrams should describe each unit operation, its placement in the overall process, monitoring and control points, and the component, as well as other processing material inputs (e.g., processing aids) and expected outputs (i.e., in-process materials and finished product). It is also useful to generate and preserve process flow diagrams of the various scales as the process design progresses to facilitate comparison and decision making about their comparability.

With this article on process validation we are concluding the series of articles on pharma process validation guidelines, pharmaceutical validations documentation fda guidelines

Also see
Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures

What is pharmaceutical product information manual (Pharmaceutical product dossier) for registration of  pharmaceutical product to foreign countries
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Process Validation guidelines Series 

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Process Validation Stage 3 The Continued Process Verification.

Process Validation : Process Qualification and Process Performance Qualification (PPQ)

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Process validation and its regulatory, statutory requirements.

Process Validation and Drug Quality Approach to Process Validation.

General Considerations for Process Validation and Recommendations

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