Bethesda, Md., August 31, 2017 – The Parenteral Drug Association (PDA) published Points to Consider for Aging Facilitiesas part of an ongoing focus on manufacturing improvements. In some cases, noncompliant, aging facilities are a reason forcing companies to cease manufacturing, which may exacerbate drug shortages.
Points to Consider for Aging Facilities reflects the general thoughts and suggestions 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 in late 2015:
- Ghada Haddad, MBA, Merck & Co./Merck, Sharp & Dohme, Co-Chair
- Maik Jornitz, MS, G-CON Manufacturing Inc., Co-Chair
- Glenn Wright, MS, Eli Lilly and Company, Co-Chair
- James Butler, MS, Cimetrics
- Jette Christensen, PhD, Novo Nordisk
- Phil Desantis, MS, DeSantis Consulting Associates
- Robert Dream, MS, PhD, HDR CO., LLC
- John Lewis, MBA, DPS Consulting, Inc.
- Anette Marcussen, MS, Novo Nordisk
- Morten Munk, NNE Pharmaplan
- Shelley Preslar, MBA, Azzur Group
- Susan Schniepp, Regulatory Compliance Associates Inc.
- Chris Smalley, PhD, ValSource
- Matthew Taylor, Eli Lilly and Company
- George Wiker, AES Clean Technology
Points to Consider for Aging Facilities is a work product of PDA’s Manufacturing Science and Operations Program (MSOPSM), and is just the latest in a series of manufacturing science technical documents published by PDA. Other, recent manufacturing-related publications include Technical Report No. 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging, Technical Report No. 70: Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities, and Technical Report No. 69: Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations.