title: A Roadmap for the Implementation of Continued Process Verification.
abstract: In 2014, the members of the BioPhorum Operations Group (BPOG) produced a 100-page continued process verification case study, entitled "Continued Process Verification: An Industry Position Paper with Example Protocol". This case study captures the thought processes involved in creating a continued process verification plan for a new product in response to the U.S. Food and Drug Administration's guidance on the subject introduced in 2011. In so doing, it provided the specific example of a plan developed for a new molecular antibody product based on the "A MAb Case Study" that preceded it in 2009.This document provides a roadmap that draws on the content of the continued process verification case study to provide a step-by-step guide in a more accessible form, with reference to a process map of the product life cycle. It could be used as a basis for continued process verification implementation in a number of different scenarios: For a single product and process;For a single site;To assist in the sharing of data monitoring responsibilities among sites;To assist in establishing data monitoring agreements between a customer company and a contract manufacturing organization.
  The U.S. Food and Drug Administration issued guidance on the management of manufacturing processes designed to improve quality and control of drug products. This involved increased focus on regular monitoring of manufacturing processes, reporting of the results, and the taking of opportunities to improve. The guidance and practice associated with it is known as continued process verification This paper summarizes good practice in responding to continued process verification guidance, gathered from subject matter experts in the biopharmaceutical industry.
authors.affiliation: Associate Director and Senior Scientist, Process Validation, Bristol-Myers Squibb, East Syracuse, NY, USA;
authors.forename: Marcus
authors.initials: M
authors.lastname: Boyer
authors.affiliation: Head of Commercial Manufacturability and Platforms, Baxalta, Vienna, Austria;
authors.forename: Joerg
authors.initials: J
authors.lastname: Gampfer
authors.affiliation: Abdelqader Zamamiri, Ph.D., Associate Director, Process Data Management, Regeneron, Rensselaer, NY, USA.
authors.forename: Abdel
authors.initials: A
authors.lastname: Zamamiri
authors.affiliation: Abdelqader Zamamiri, Ph.D., Associate Director, Process Data Management, Regeneron, Rensselaer, NY, USA robin@biophorum.com.
authors.forename: Robin
authors.initials: R
authors.lastname: Payne
mesh_terms: D001702:Biopharmaceutics / Q000331:legislation & jurisprudence / Q000592:standards*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations
keywords: Biopharmaceutical; CPV; Continued process verification; Regulatory guidance