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Documenting Process Validation
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Documenting Process Validation
€ 265.00
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€ 315.35
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US$
377.00
A Drugmaker‘s Guide
100 Pages
ISBN: 978-3-943267-65-5
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. The most common mistakes occur after the work of validation has taken place: when documenting the work to show that it’s been done.

FDA inspectors examiners are trained to be sticklers, and their mantra: "If it isn’t written down, it didn’t happen." Now, two experts with decades of production-line experience have teamed to produce the definitive guide to documenting process validation in pharmaceutical manufacturing.

Here’s a step-by-step manual based on real-world examination experience. You’ll discover how to document process validation in a way that’s sure to satisfy — and impress — regulators.

You’ll confront and solve the slipperiest problems, including creating, establishing and organizing:

- Validation master plans that express corporate commitment
- Validation matrices that list all processes to be tested and actions to be taken
- Protocols for every individual validation activity
- How to describe sampling methods for each protocol
- How to correctly interpret validation results
- Knowing what to include in validation reports
- And much more

BONUS feature:
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
- Test Plan:
gives detailed descriptions of tests to be carried out, including frequency, methods, sampling and acceptance limits

Reading Sample

Documenting Process Validation - Reading Sample

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Technical Requirements

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Dr. Christine Oechslein, GMP Instructor, Germany
Max Lazar, FDA Regulatory Compliance Consulting, USA
Recommendations
PDA Technical Report No. 60 Process Validation
GMP Compliant Documentation
GMP Audit Checklist (Download)