FDA Regulatory Compliance - Contract Manufacturing And Quality Management Agreements

Why do you need to get one? You may be one inspection away from a misbranding or adulteration claim.

On May 28, 2013 FDA issued its Draft Guidance entitled Contract Manufacturing Arrangements for Drugs. The Draft Guidance concerns active pharmaceutical ingredients (APIs) and finished products that result in a "drug that is intended to be marketed, distributed, and sold." The term "manufacturing" is defined to include "processing, packing, holding, labeling operations, testing, and operations of the Quality Unit."

As with all guidance documents, FDA states it is merely describing its "current thinking on a topic and should be viewed only as recommendations" but the agency will be looking for these Contract Manufacturing and Quality Management Agreement in its routine inspections.

The draft guidance cites International Conference on Harmonization quality guidelines Q7, Q9 and Q10, highlighting an assessment of the "suitability and competence of the potential Contracted Facility" and the need for a formal Contract Manufacturing and Quality Management Agreement to detail quality management practices.

FDA regulations already require that manufacturing procedures be written. According to the Draft Guidance implementing a written Quality Agreement will facilitate compliance with the regulations." FDA expects comprehensive written agreements that define and establish "the obligations and responsibilities of the Quality Units of each of the parties involved in the contract manufacturing of drugs." FDA further recommends that the representatives from each party's quality control group participate in drafting the Agreement and that it be separate from Master Services Agreements, Supply Agreements, and other documents that FDA does not routinely review. FDA is looking for these Agreements to be among the documents "routinely requested and reviewed."

Contract Manufacturing And Quality Management Agreements Should Contain The Following:

Purpose/Scope; Terms (including effective date and termination clause); Dispute Resolution; Responsibilities (including communication mechanisms & contacts); and Change control and revisions. In establishing the responsibilities the Agreement should detail:

Quality Unit Responsibilities: According to FDA, this is "perhaps the most critical element of a Quality Agreement, should define in detail the CGMP responsibilities of each party, including the quality activities and measures." Facilities and equipment: Identify the...