IPAC-RS Webconference for Suppliers and OINDP Manufacturers
The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) Supplier Quality Working Group is hosting a 1.5 hour web-conference for suppliers of container closure system and/or device materials and components for orally inhaled and nasal drug products (OINDP), as well as OINDP manufacturers/developers.
This web-conference will offer a unique opportunity for suppliers to hear from manufacturers about expectations on component quality, and to express views on key supplier quality issues. The web-conference will include presentations by representatives from leading OINDP manufacturers and suppliers on:
- The Regulatory and Scientific Context for Enhancing Quality of OINDP Materials and Components
- Information on IPAC-RS and its Supply Chain Activities
- Current and Planned Initiatives to Enhance Quality of OINDP Materials and Components
- How to Get Involved
- Open Discussion and Q/A
The material presented will be important for pharmaceutical companies, suppliers of finished OINDP components, and upstream suppliers such as resin manufacturers and rubber compounders.
US/Europe Web-conference
Thursday, 1 July 2010
10:00 - 11:30 AM ET/15.00 - 16.30 UK/16.00 - 17.30 CET
Asia Web-Conference
Thursday, 15 July 2010
9:30 – 11:00 AM (India)/12:00 – 1:30 PM (Beijing)/1:00 – 2:30 PM (Tokyo)
To register for the web-conference, please go to: www.signmeup.com/70613
Flyers
1 July 2010 US/Europe Webconference Flyer
15 July 2010 Asia Webconference Flyer
15 July 2010 Asia Webconference Flyer (Chinese version)
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.
Toolkits
The IPAC-RS Supplier Quality Working Group has developed three toolkits for suppliers and orally inhaled nasal drug products (OINDP) manufacturers:
Quality Agreement Template. The template provides guidance on elements of a quality agreement between OINDP manufacturers and their component/ packaging suppliers (N-1 suppliers), and N-1 suppliers and their suppliers. The template links specific elements of the quality agreement with GMP recommendations made in the Working Group's GMP Guideline for Suppliers of Components for OINDP.
Regulatory Requirements Toolkit. This toolkit describes regulatory expectations associated with OINDP, and provides references to key regulatory documents important for suppliers and OINDP manufacturers.
Performance Requirements Toolkit. This toolkit describes basic expectations for performance of OINDP, and relates these to GMP and quality.
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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