Managing Process Validation - A Drugmaker's Guide
A step-by-step guide based on real-world examination experience. Discover how to document process validation in a way that is sure to satisfy – and impress – regulators!
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Excerpt from the GMP Compliance Adviser
Few things in drugmaking are as challenging as process validation — nor as likely to trip you up with FDA inspectors. Hundreds of individual manufacturing processes to validate. And the most common mistakes occur after the work of validation has taken place: when documenting the work to show that it’s been done.
What validation method should you use? Who should be involved in validation? When should you conduct the validation?
You are beyond the introduction to process validation and ready to get straight to the heart of the matter.
Managing Process Validation: A Drugmaker’s Guide — written by pharma industry veteran and GMP specialist, Dr. Christine Oechslein — gives you the information you need to craft a solid validation program, including:
- How to choose the appropriate validation method (prospective, retrospective or concurrent)
- How to build a validation team and assign tasks and responsibilities
- Factors to consider when outsourcing validation
- Setting critical process parameters and operational ranges
- Dealing with equipment calibration and qualification
- Validating computer systems
- How to develop a validation matrix
- What information to include in a validation protocol
- How to document the validation
Order Managing Process Validation: A Drugmaker’s Guide and gain the confidence to conduct process validations that reduce risk and satisfy regulators.
Detailed sample documents to adapt to your specific manufacturing situations:
- Sample Validation Master Plan:
includes scope of plan, key terms, validation policy, organization responsibilities, and more
- Validation Matrix:
featuring table listing key details of each validation project in the master plan
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