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Documenting Process Validation: A Drugmaker’s Guide

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September 2012
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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.

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

Co-authors Christine Oechslein and Max Lazar are ideal guides to this complex manufacturing and regulatory challenge:

  • Christine Oechslein spent 23 years in drug manufacturing and development, mostly with Sandoz and Novartis. She developed oral drug delivery systems, headed a lab for development of nasal and pulmonary dosage forms, and helped create a quality manual for Rx development.
  • Max Lazar spent 35 years at Hoffmann-La Roche, where he was in charge of compliance oversight for all Roche USA businesses. For the past 13 years, he has consulted to drugmaking clients on API GMP issues and ICH Q7A Guidance training, for which he won an FDA Commissioner’s Special Citation.

Looking for a plain-English guide to complex technical matters? Need methods to apply consistent standards across multiple manufacturing operations? Want to gain the confidence of inspectors that your operation is qualified to meet high manufacturing standards? Look no further. Documenting Process Validation: A Drugmaker’s Guide is that document.

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