Risk Management within the Global Supply Chain - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Risk Management within the Global Supply Chain
The authors describe a program to identify, prioritize, mitigate, and communicate risks in manufacturer–supplier relationships.


Pharmaceutical Technology


Conclusion

Because of the rapid growth of the global supply chain for the pharmaceutical industry, increased risk management is essential to ensure regulatory compliance and consumer safety. By implementing the ideas and tools described in this article, the pharmaceutical manufacturer will reduce risk, enhance patient safety, and ensure long-term success for its products.

Sarah Wood* is a quality-systems manager, Ronald Dunn is the director of quality systems, Marsha Nelson is a senior quality engineer, Taunya Alexander is a quality-program manager, and Larry Servi is the director of product and process development, all at Regulatory Compliance Associates, 7401 104th Ave., Suite 160, Kenosha, WI 53142, tel. 262.842.1250, fax 262.842.1251,
. Susan Schniepp is the president of Schniepp and Associates and a member of Pharmaceutical Technology's Editorial Advisory Board.

*To whom all correspondence should be addressed.

References

1. D.H. Stamatis, Failure Mode and Effect Analysis: FMEA from Theory to Execution, (American Society for Quality, Milwaukee, WI, 2nd ed., 2003).

2. Dyadem Press, Guidelines for Failure Modes and Effects Analysis (FMEA) for Medical Devices, (CRC Press, Boca Raton, FL, 2003).


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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: Pharmaceutical Technology,
Click here