A recent FDA Form 483 observation highlights the absence of robust quality agreement between a pharmaceutical company and their contract manufacturing organization (CMO).
The Code of Federal Regulations (CFR) section 21 CFR 820.50 states “each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.”
Sourcing from FDA guidance, “A quality agreement describes the owner’s and the contract facility’s roles and manufacturing activities under CGMP.”
Quality Agreements delineate the responsibilities of each party in ensuring that the drug products meet all necessary quality standards, safety requirements, and regulatory compliance. Absence of Quality Agreements can lead to severe non-compliance.
The following FDA Form 483 between a pharmaceutical firm and their contract manufacturing organization examples the absence of a quality agreement.
….There is no quality control unit.
Specifically, your firm imported and distributed your own-label drug products, …. and …. However, your firm failed to carry out the following quality control duties:
a.Your firm has not established with its contract manufacturing organization (CMO) an agreement which delineates the CGMP-related roles and activities of each party in ensuring the safety, efficacy,and quality of its own-label drug products.
b.Your firm has not qualified its CMO to ensure its contracted supplier will supply drug products which meet quality standards or ensuring its contracted warehouse/fulfillment center will hold drug products under conditions which meet CGMP requirements.
c.Your firm has not ensured the certificate of analyses provided by its CMO are reliable and accurate to ensure that the drug products are suitable to be released for distribution.
As seen in this 483, establishing Quality Agreements is critical to ensuring product quality and regulatory compliance.
FDA guidance delineates that a sound quality agreement should include:
- 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 activities associated with manufacturing processes as well as control of changes to manufacturing processes
- Life cycle of, and revisions to, the quality agreement
FDA guidance on Contract Manufacturing Quality Agreements is a great source to learn more about quality agreements
Continuous coordination and improvement with a CMO is necessary to ensure product quality and create a healthy professional dynamic amongst all stakeholders at each firm.
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