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A Roadmap for the Implementation of Continued Process Verification.

Marcus Boyer1, Joerg Gampfer2, Abdel Zamamiri3

  • 1Associate Director and Senior Scientist, Process Validation, Bristol-Myers Squibb, East Syracuse, NY, USA;

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Summary
This summary is machine-generated.

This guide offers a step-by-step roadmap for implementing continued process verification (CPV) in biopharmaceutical manufacturing. It simplifies the BioPhorum Operations Group

Keywords:
BiopharmaceuticalCPVContinued process verificationRegulatory guidance

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Validation
  • Quality Control

Background:

  • The U.S. Food and Drug Administration (FDA) issued guidance in 2011 emphasizing continuous monitoring and improvement of drug manufacturing processes.
  • This guidance, known as continued process verification (CPV), aims to enhance product quality and control.
  • The BioPhorum Operations Group (BPOG) developed a comprehensive case study in 2014 detailing CPV implementation for a new molecular antibody product.

Purpose of the Study:

  • To provide an accessible, step-by-step guide for implementing continued process verification (CPV).
  • To serve as a roadmap based on the 2014 BPOG industry position paper and its example protocol.
  • To support CPV implementation across various scenarios, including single products, sites, and contract manufacturing organizations.

Main Methods:

  • Leveraging the 2014 BPOG "Continued Process Verification: An Industry Position Paper with Example Protocol" as a foundation.
  • Referencing a product lifecycle process map to illustrate CPV stages.
  • Adapting the methodologies for diverse implementation contexts such as single-product, single-site, multi-site data sharing, and customer-contractor agreements.

Main Results:

  • A simplified, actionable roadmap for CPV implementation derived from industry best practices.
  • A framework adaptable to different biopharmaceutical manufacturing scenarios.
  • Facilitation of data monitoring and agreement establishment between stakeholders.

Conclusions:

  • The provided guide simplifies the complex process of continued process verification implementation.
  • It offers a practical tool for biopharmaceutical companies to comply with FDA guidance and enhance process control.
  • The roadmap supports efficient and effective CPV strategies across various organizational structures and collaborations.