Materials for OINDP

Baseline Requirements Document

The IPAC-RS OINDP Materials Working Group has worked with suppliers to develop baseline requirements for materials used to manufacture components for OINDP. The impetus for this document was based on requests for a uniform set of requirements arising from several discussions between pharmaceutical manufacturers, regulators and multiple suppliers in meetings sponsored by IPAC-RS. As there is no single guidance for these types of materials, these requirements were compiled from a variety of international regulatory and compendial guidelines and standards. A copy of the Baseline Requirements for Materials used in Orally Inhaled and Nasal Drug Products (OINDP) is available here: Baseline Requirements.

13-14 September 2009 Materials Forum

The IPAC-RS OINDP Materials Working Group hosted a 1.5 day Materials Forum held in Philadelphia, PA on Sunday-Monday, 13-14 September 2009. The Forum brought together pharma, suppliers, and regulators to address challenges and develop solutions in materials supply and testing for OINDP. The Forum advanced discussion on key issues noted during the Barcelona Materials Forum that was held on 12 May. Click here for the final program: Final Program.

Click on the following links to access the slides from the September 2009 Forum.

• Background on IPAC-RS: Barbara Falco, Abbott
• Materials Variability: How Much?
  • OINDP Sponsor: Bobbijo Redler, Schering-Plough
  • Converter: Keith Wilbourn, Rio Tinto Alcan
  • Raw Materials Supplier: Michael Luetke, LyondellBasell
• Focused Testing: Is it Possible? Jamie Mullis, Boehringer Ingelheim
• Current Initiatives
  • ELSIE: Art Shaw, Pfizer
  • Polymer Forum: Cheryl Stults, Novartis
    
    

12 May 2009 Materials Forum

The IPAC-RS OINDP Materials Working Group hosted a Materials Forum in Barcelona, Spain on Tuesday, 12 May 2009. The Forum brought together pharma, suppliers, and regulators to address challenges and develop solutions in materials supply and testing for OINDP.

The Final Program is available here: Final Program.

Click on the following links to access the slides from the May 2009 Forum.

Material Variability: How Much?