Three-and-a-halfyearsinthemaking, the U.S. Foodand 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
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
FDA Issues Final Guidance on
Says the difference between the draft from May ’ 13 and the final guidance focuses on areas that
needed to be clarified