Three-and-a-half years in the making, the U.S. Food and Drug Administration (FDA) has finalized guidelines suggesting what should go into quality agreements between pharma companies and contract manufacturing organizations (CMOs). It’s important because nearly two-thirds of pharmaceutical manufacturing today is outsourced to CMOs.

In the 16-page document, entitled, “Contract Manufacturing Arrangements for Drugs: Quality Agreements,” FDA recommends that owners and contract manufacturers implement written quality agreements to define each party’s manufacturing activities/roles to ensure compliance with current good manufacturing practices (cGMPs).
The agency says the agreements should provide:

1. Purpose and scope to cover the nature of the contract manufacturing services to be provided;
2. Definitions to ensure that the parties agree on precise meaning of terms;
3. A resolution of disagreements section describing how the parties will resolve disagreements regarding issues, such as quality;
4. Manufacturing activities to document quality unit and other activities associated with manufacturing processes, as well as control of changes to manufacturing processes; and
5. Life cycles of, and revisions to, the quality agreement.

For this issue we called on the experts at Lachman Consultant Services, Inc. to provide analysis of the document. Beginning on page 32, Paul Mason, a director in the science and technology practice at Lachman, fleshes out the important details.

He says, “The quality agreement should clearly describe the materials or services to be provided, quality specifications and define the communication mechanisms between owner and contract facility. The quality agreement should address items that have a potential to impact the quality of the contract facilities deliverable, such as: subcontracting by the contract facility; and addressing change to processes, equipment, methods, specification, records/data, etc.”

The agency also added that the quality agreements may be reviewed during inspections, and they should remain separate from other business documents.

Tim Wright, Editor
twright@rodmanmedia.com