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Validation Master Plans: Progress of Implementation in the Pharmaceutical Industry.

Clare Elser1, Frances J Richmond1

  • 11 Department of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California, Los Angeles, CA, USA.

Therapeutic Innovation & Regulatory Science
|July 5, 2018
PubMed
Summary

Validation Master Plans (VMPs) are increasingly adopted by US pharmaceutical companies, becoming an industry standard even without explicit US regulatory mandates. Implementation varies by company size, with most using paper-based systems.

Keywords:
ISPE Baseline GuidePI-006-03quality systemsvalidation

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Area of Science:

  • Pharmaceutical Quality Systems
  • Regulatory Compliance
  • Drug Manufacturing

Background:

  • International regulatory agencies often mandate Validation Master Plans (VMPs).
  • VMPs are not explicitly required by US regulations.
  • This study assesses VMP implementation in US pharmaceutical companies under FDA Good Manufacturing Practice.

Purpose of the Study:

  • To examine the adoption and implementation of Validation Master Plans (VMPs) in US pharmaceutical companies.
  • To understand how VMPs are integrated into quality systems for drug product manufacturing.
  • To identify differences in VMP implementation strategies across companies.

Main Methods:

  • A survey instrument was developed based on a behavior and capability framework.
  • The survey was electronically distributed to US-based mid- and senior-level regulatory and quality professionals.
  • Responses were collected from 42 senior regulatory professionals.

Main Results:

  • VMPs are integrated into the quality systems of most surveyed companies.
  • Implementation approaches vary, with small companies favoring centralized VMPs and larger companies often decentralizing.
  • Most companies, regardless of size, use paper-based tools for managing validations, including equipment validation.

Conclusions:

  • The widespread use of VMPs, despite lacking explicit US mandates, indicates they are becoming an industry standard.
  • Global standards appear to significantly influence the quality management approaches of US pharmaceutical companies.
  • VMPs are evolving as a key component of pharmaceutical quality assurance in the US.