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
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here