Quality Agreements: Contract Manufacturing Arrangements for Drugs

• By: Staff Editor
• Date: December 05, 2016
• Source: http://www.fda.gov/

Quality Agreements: Contract Manufacturing Arrangements for Drugs

Drug manufacturers who use contract facilities now have final guidance from the FDA on quality agreements. Consequently, the drug makers and contractors need to review their existing agreements to ensure compliance with the final requirements.

Drug manufacturing comprises many distinct processes and operations. The manufacturer may perform all operations or may engage an outside party to perform some of the processes under contract. Contract facilities perform a variety of manufacturing operations including:

• Formulation
• Fill and finish
• Chemical synthesis
• Cell culture and fermentation, including for biological products
• Analytical testing and other laboratory services
• Packaging and labeling
• Sterilization or terminal sterilization

Quality Agreements

A Quality Agreement is a comprehensive written contract between a pharmaceutical firm and a GMP contract manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug. Quality agreements should not include general business terms and conditions such as confidentiality, pricing or cost issues, delivery terms, or limits on liability or damages.

FDA endorses that quality agreements should be separate documents from commercial contracts such as master services agreements or supply agreements. FDA may review the quality agreements during inspections and audits.

Elements of a Quality Agreement

• Purpose/Scope: to cover the nature of the contract manufacturing services to be provided
• Definitions: to ensure that the owner and contract facility agree on precise meaning of terms in the quality agreement
• Resolution of disagreements: to explain how the parties will resolve disagreements about product quality issues or other problems
• Manufacturing activities: to document quality unit and other operations associated with manufacturing processes as well as control of changes to manufacturing processes
• Lifecycle of, and revisions to, the quality agreement

Related Training:

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes