Standardized Quality Agreements - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Standardized Quality Agreements
Representatives of SOCMA and IPEC explain new quality agreement templates and their use for meeting regulatory expectations and securing the pharmaceutical supply chain.

Pharmaceutical Technology
Volume 34, pp. s56-s62

Conclusion

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.

References

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, http://www.ipqpubs.com/wp-content/uploads/2010/06/XavierUnivpresentationHASSELBALCH.pdf.

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),
.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
28%
Attracting a skilled workforce
26%
Obtaining/maintaining adequate financing
13%
Regulatory compliance
33%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here