Introduction

The new FDA Draft Guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements” focuses on the documented and agreed upon responsibilities of the "Owner” and the "Contracted Facility”. A key component is the level of Quality Oversight from the Owner of the drug product before, during the contract negotiation and after the signed agreement is in place. ICH Q10 and other Quality Management guidance discusses the controls required over outsourced activities in general. Understanding that Contract Manufacturing and Testing services are extremely critical, the questions is – are these outsourced activities the only ones that require a formal Quality Agreement? There are other critical outsources activities that should have the same level of formality, communication and documentation requirements.

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online, 201,N Squirrel road,, Suite 1007,, Auburn Hills,, michigan., 48326., United States

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Global Compliance Trainings

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john gordan
201,N Squirrel road, Suite 1007, Auburn Hills, Suite 1007,, Auburn Hills,, michigan., 48326, United States of America
2482120588
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