Ordering IPAC-RS GMP Guideline
To order a copy of the GMP Guideline for Suppliers of OINDP Device Components, please go to http://www.signmeup.com/56506.
Past Supplier Quality Control Workshops
May 28, 2008
The IPAC-RS Supplier Quality Control Working Group hosted a one-day European training course on the IPAC-RS GMP Guidelines for Suppliers of components used in orally inhaled and nasal drug products (OINDP).
The course addressed key aspects of the Guideline in detail and allowed for open discussion and sharing of experiences. Topics covered included:
- Developing a “Roll Out Plan”
- Developing Quality Systems to Supply to OINDP: Practical Applications of the Guideline
- Change Control
- Extractables
- Process Controls
The Final Program is available here: Final Program
Click on the following links to access the slides from the May 2008 Training Course.
September 24-25, 2007
IPAC-RS hosted a one and a half day workshop Workshop on Extractables and GMP for Components of Inhalation & Nasal Drug Products on 24-25 September 2007 in Basel, Switzerland. The workshop addressed the expectations for quality (including GMPs) and extractables evaluation of components and materials intended for use in OINDP, and provided opportunities for interaction and dialogue between all links in the OINDP supply chain, from base material suppliers to pharma companies. Topics covered included analytical and toxicological evaluation of extractables in development and routine control; regulatory expectations; managing change; the IPAC-RS GMP Guideline for Suppliers; and communication between OINDP manufacturers and suppliers.
The final program is available here: Final Program.
For a summary of the Workshop, click here: Summary Report
Click on the following links to access the slides from the September 2007 Workshop.
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