The final section of the IPEC Quality Agreement Template includes the names and contact information for the quality contacts
of both parties. The identified individuals should be the persons responsible for compliance with the quality agreement as
well as the ongoing maintenance of the agreement. Signatories to the agreement, appendices, and references are also included.
Having appropriate quality agreements in place can significantly improve communication, limit product quality issues that
result from misunderstandings, and improve supply-chain relationships. The IPEC Quality Agreement Template can help users
and suppliers of excipients reduce the time and effort needed to complete successful quality agreements and ensure that agreement
on important points is achieved.
1. FDA, Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations (Rockville, MD, 2006).
2. B. Hasselbalch, "Public Health challenges for the Quality of Human Drugs," presented at the 2010 FDA/Xavier University
Global Outsourcing Conference, Cincinati, OH, June 2010,
3. IPEC, Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients (2006)
View the IPEC and SOCMA Quality Agreement Templates at www.PharmTech.com/QualityAgreements
Plus: Read more about the US Food and Drug Administration's expectations for Quality Agreements in the August 2010 issue of
Pharmaceutical Technology, Insider Solutions column.
Alexa Smith is the Global Regulatory Services Manager for Colorcon (Harleysville, PA) and chair of the Quality Agreement Template Subcommittee
of the International Pharmaceutical Excipient Council (IPEC), ASmith@colorcon.com