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.