Managing Contract Manufacturing Organization Relationships - Successful management of the CMO/client relationship should include open communication and trust. - BioPharm International

ADVERTISEMENT

Managing Contract Manufacturing Organization Relationships
Successful management of the CMO/client relationship should include open communication and trust.


BioPharm International Supplements
Volume 26, Issue 3, pp. s22-s26

CONCLUSION


Key Points
Remember that the CMO is an extension of the client. The client is responsible for the CMO. The quality unit in a company should act as the "internal FDA"; if the unit is doing its job, FDA inspections will be painless (or, at least, less painful). Develop relationships with CMO personnel; go beyond just a business relationship. Define a scorecard with KPIs. Hold each other accountable. Quarterly business review meetings should be held and all decisions should be clearly documented. The client should visit CMO facilities and know the processes. Most importantly, the client and the CMO should have open and honest communication and build trust.

Chris Masterson is vice-president of quality at Cubist Pharmaceuticals,

REFERENCES

1. 21 CFR 200.10 Contract Facilities

2. FDA Safety and Innovation Act (FDASIA)

3. ICH Q10, Modern Pharmaceutical Quality Systems.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

FDA and NIH Win Award for IP Licensing of Meningitis Vaccine
September 26, 2014
FDA Releases First-Ever Purple Book for Biosimilar Characterization
September 26, 2014
FDA Releases REMS Report
September 25, 2014
NIH Funds Tissue Chip for Drug Screening
September 25, 2014
UPS' Pain in the Supply Chain Results
September 23, 2014
Author Guidelines
Source: BioPharm International Supplements,
Click here