Contains Nonbinding Recommendations
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• Manufacturing includes processing, packing, holding, labeling operations, testing, and
quality unit operations.
• A manufacturer is an entity that engages in CGMP activities, including implementation
of oversight and controls over the manufacture of drugs to ensure quality.
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• Quality unit is defined as synonymous with the term quality control unit.
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This guidance covers commercial manufacturing of the following categories of drugs: human
drugs, veterinary drugs, certain combination products, biological and biotechnology products,
finished products, APIs, drug substances, in-process materials, and drug constituents of
combination drug/device products.
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This guidance does not cover the following types of
products: Type A medicated articles and medicated feed, medical devices, dietary supplements,
or human cells, tissues, or cellular or tissue-based products regulated solely under section 361 of
the Public Health Service Act and 21 CFR part 1271.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II. DEFINING THE WHO AND WHAT OF CONTRACT MANUFACTURING
This guidance describes how contract manufacturing operations fit within the larger scheme of
pharmaceutical quality systems. It also presents the Agency’s current thinking on the roles and
manufacturing activities of the parties involved in contract manufacturing arrangements.
Specifically, this guidance addresses the relationship between owners and contract facilities. For
purposes of this guidance, we define owners as manufacturers of APIs, drug substances, in-
process materials, finished drug products, including biological products, and combination
products. The term owner does not apply to retail pharmacies, drug stores, supermarkets,
discount warehouse stores, or other retailers who purchase finished drug products to sell over the
counter as a store brand. For purposes of this guidance, we define contract facilities as parties
that perform one or more manufacturing operations on behalf of an owner or owners.
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See section 501 of the FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act
(Public Law 112-144, title VII, section 711).
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For quality control unit, see 21 CFR 210.3.
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Combination product manufacturers can apply this guidance to their quality agreements because they are subject to
requirements under 21 CFR part 211 and/or 21 CFR part 820 (see 21 CFR 4.3). In addition to facilitating
compliance with requirements under 21 CFR part 211, manufacturers can use quality agreements with contract
facilities to demonstrate compliance, in part, with 21 CFR 820.50 (purchasing controls) and with 21 CFR 820.80(b)
(receiving acceptance activities) for combination products.
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A contract facility may also be an owner depending on its role (e.g., when the contract facility is using a
subcontractor).