The multi-faceted effort by the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) to instill the quality management concepts detailed in its component GMP guidelines into the complex supply chain for orally inhaled and nasal drug products (OINDPs) is continuing to bear fruit.
The consortium’s initiatives to drive forward the implementation of its guideline include: ● a collaborative effort with UK’s Pharmaceutical Quality Group (PQG) to incorporate the IPAC -RS guideline into PQG’s umbrella GMP standard for pharmaceutical packaging suppliers, PS 9000 ● outreach and training sessions with the component supplier community and regulatory agencies, and ● the development of “toolkits” to help industry address issues such as change and risk management and quality agreements.
Industry consultant and member of the consortium’s supplier quality working group (SQWG) Barbara Falco addressed the initiatives and the importance of what they are trying to accomplish at a session of the IPAC-RS 2011 conference in late March in Rockville, Maryland. [Editor’s note: Falco’s complete remarks are included at the end of the story.]
“The goal is to bring more and more suppliers deeper in the supply chain into the fold,” Falco emphasized, because “the OINDP component supply chain has a very big impact on quality, safety, and efficacy of the products for our patients.”
[Falco’s analysis of the OINDP component supply chain and the IPAC-RS initiatives is provided is provided for subscribers here. The full story can be purchased for $195 by contacting Peter Blachly (Peter@ipq.org). For subscription information click here.]