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Quality Oversight 2020 - Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)



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The globalization of the pharmaceutical supply chain has resulted in the increased use of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it also presents unique compliance risks, particularly since operations are not under your direct control.
If you use CMOs, your firm is fully responsible for product quality, safety, efficacy, and cGMP compliance. Furthermore, FDA has clearly stated that firms using CMOs will be held accountable for CMO compliance to cGMPs, as well as for CMO adherence to Sponsor regulatory commitments. Issues
Understand the CMO business model
Understand the regulatory requirements for CMO quality oversight
Understand how to structure your organization for effective CMO oversight
Understand key points for selecting and qualifying CMOs
Andrew Campbell has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models.

Last modified: 2020-09-28 22:37:34