pharmaceutical process validation
TRANSCRIPT
Definitions EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1Guideline on process validation for finished products - information and data to be provided in regulatory submissions
• Process validation can be defined as documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.
• Process validation should not be viewed as a one-off event. Process validation incorporates a lifecycle approach linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production.
General
• Process validation should cover all strengths and all manufacturing sites
• Bracketing approach possible for different strengths, batch sizes and pack sizes, but not for different manufacturing sites
• Prospective Process Validation• Prior to marketing
• Concurrent Process Validation• In exceptional circumstances; justification needed
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Process validation approaches (EU)• Traditional process validation
• Number of batches manufactured under routine conditions to confirm reproducibility
• Continuous process verification• In addition to, or instead of, the traditional approach• Science and risk-based real-time approach
• Hybrid approach• Combining traditional and continuous process verification
• Design space verification
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Process validation stages (FDA)
1. Process Design• The commercial manufacturing process is defined during this stage
based on knowledge gained through development and scale-up activities
2. Process Qualification• During this stage, the process design is evaluated to determine if the
process is capable of reproducible commercial manufacturing
3. Continued Process Verification• Ongoing assurance is gained during routine production that the
process remains in a state of control
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Regulation and guidance related to Process Validation
• EMA Guality guidelines
• EudraLex - Volume 4 GMP Guidelines
• FDA Current Good Manufacturing Practices (CGMPs)/Compliance
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• Do you need help in writing process validation protocols/schemes or process validation reports for pharmaceuticals?
• Do you need consultation related to process validation documentation to be provided with regulatory submissions?
• Are you familiar with the current requirements?• We participated in ECA course ”The new FDA/EU Approach to
Process Validation”• We have an expert team ready to help you!
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