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PDA Publishes PtC on Aging Facilities

Oct 03, 2017

This summer, PDA published its Points to Consider for Aging Facilities document as part of an ongoing focus on manufacturing improvements. In some cases, noncompliant, aging facilities are a reason companies cease manufacturing, which may exacerbate drug shortages.

Points to Consider for Aging Facilities reflects the general thoughts of the pharmaceutical manufacturing industry on how to identify and modernize aging facilities. It covers eight critical areas to help companies avoid the traps encountered by other companies: Recognizing an Aging Facility, Impediments to Modernization, Business Case for Modernization, Impact of Changing Standards, Slowing the Aging Process and Regulations.

A team of industry experts developed this document based on responses to a PDA workshop held in March 2015 and a survey of PDA members conducted later that year. This team consisted of:

  • Ghada Haddad, Merck & Co./Merck, Sharp & Dohme, Co-Chair
  • Maik Jornitz, G-CON Manufacturing, Inc., Co-Chair
  • Glenn Wright, Eli Lilly and Company, Inc., Co-Chair
  • James Butler, Cimetrics
  • Jette Christensen, PhD, Novo Nordisk A/S
  • Phil DeSantis, DeSantis Consulting Associates
  • Robert Dream, PhD, HDR Company, LLC
  • John Lewis, DPS Consulting
  • Anette Marcussen, Novo Nordisk A/S
  • Morten Munk, NNE
  • Shelley Preslar, Azzur Group, LLC
  • Susan Schniepp, Regulatory Compliance Associates Inc.
  • Chris Smalley, PhD, ValSource
  • Matthew Taylor, Eli Lilly and Company
  • George Wiker, AES Clean Technology

The document can be purchased at the PDA Bookstore.

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