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Comments to FDA on “Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements”

July 29, 2013

Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Re: Docket No. FDA– 2013-D-0558 "Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements"

Dear Dockets Manager:

AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.

AABB appreciates the opportunity to provide a response to the Food and Drug Administration on the recommendations contained in the draft guidance document titled "Contract Manufacturing Arrangements for Drugs: Quality Agreements". The quality framework used by AABB to develop standards includes requirements for written agreements between facilities to define supplier and customer expectations, reviews of the agreements to incorporate changes and communication of such changes, and clear delineation of responsibilities related to the requirements of the Standards. As such, AABB supports the use of written Quality Agreements. The draft guidance document emphasizes the important point that a Quality Agreement will not alleviate either party of its responsibility under existing current Good Manufacturing Practices (CGMP) regulations, or Federal Food, Drug, and Cosmetic Act (the Act), and contains useful definitions and references to several other applicable guidance documents.

The agency rightly states in the Federal Register (FR) notice that written Quality Agreements are not explicitly required under existing CGMP regulations or the Act. The FR background language further explains how owners and contracted facilities can draw on quality management principles to carry out the complicated process (emphasis added) of contract drug manufacturing when implementing written Quality Agreements as a tool to delineate responsibilities and assure the quality, safety, and effectiveness of drug products. AABB encourages the agency to recognize the variability in Quality Agreements that different facilities will use to describe their contract manufacturing arrangements. There is no one template that works for all facilities even for those facilities that are contracting out the same operation.

Thank you for the opportunity to offer these comments. Questions may be addressed to me at acarrgreer@aabb.org.

Sincerely,

M. Allene Carr-Greer
Director, Regulatory Affairs
Eduardo Nunes
Senior Director of Policy, Standards, and Global Development