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

Bristol-Myers Squibb and Five Prime Therapeutics Collaborate on Development of Immunomodulator
November 26, 2014
Merck Enters into Licensing Agreement with NewLink for Investigational Ebola Vaccine
November 25, 2014
FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
November 25, 2014
AstraZeneca Expands Biologics Manufacturing in Maryland
November 25, 2014
GSK Leads Big Pharma in Making Its Medicines Accessible
November 24, 2014
Author Guidelines
Source: BioPharm International Supplements,
Click here