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GUIDANCE DOCUMENT

Questions and Answers on Current Good Manufacturing Practice Questions and Answers on Current Good Manufacturing Practice Requirements | General Provisions April 2009

Final Level 2 Guidance
Docket Number:
FDA-2017-D-6821
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Contains Nonbinding Recommendations

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As part of the Current Good Manufacturing Practices (CGMP) initiative announced in August of 2002, and to help FDA be more transparent with CGMP policy, we have developed this question and answer resource on current good manufacturing practices. We intend to use this format to provide timely answers to questions about the meaning and application of CGMP requirements for human, animal, and biological drugs, and to share these widely. These questions and answers clarify statements of existing requirements or policy that are minor in nature, and as such, are considered Level 2 guidance. You may submit comments on this guidance at any time. Submit comments to Docket No. FDA-2017-D-6821 (see the instructions for submitting comments in the docket). This resource is being cosponsored by CDER, CVM, CBER, and ORA. The Q&As generally clarify the existing CGMP regulations for finished pharmaceuticals: 21 CFR part 211.

1. Are USP general chapters above <999> considered equivalent to FDA guidance? What is their purpose and how should manufacturers use these informational chapters? 

2. How does one comment on FDA’s proposed guidance documents?  How about USP proposals?

 1. Are USP general chapters above <999> considered equivalent to FDA guidance?  What is their purpose and how should manufacturers use these informational chapters? 

No, FDA is the only source of policy on pharmaceutical CGMP and quality.  CGMP requirements are found in statutes and regulations, and FDA’s current thinking on these requirements is explained in the Agency’s guidance documents.

The U.S. Pharmacopeial Convention is a private, nongovernmental organization that publishes the United States Pharmacopeia (USP) and the National Formulary (NF) as official compendia of the United States. Although much of the USP and NF is legally enforceable, the USP general chapters numbered above <999> (general information chapters) are informational and generally do not contain any mandatory requirements (see USP General Notices 2.10). General information chapters might include some recommendations that may help a firm meet CGMP requirements.

References:

Date: 6/14/2007

2. How does one comment on FDA’s proposed guidance documents?  How about USP proposals?    

Both USP and FDA have mechanisms in place for interested parties to make comments on proposed documents.    

Guidance Documents

FDA’s proposed guidance documents are written using good guidance practices and published for comment per 21 CFR 10.115.  They are easily accessible to the public via our Web site and through the Federal Register.  FDA’s Division of Dockets Management is the office responsible for receiving all comments on proposed guidance.  Interested parties can read and submit comments via FDA’s Dockets Management Web site.  FDA reviews all received public comments, makes appropriate modifications, and publishes a final document.

USP Monographs

USP publishes proposed chapters or monographs in the Pharmacopeial Forum, a publication that is issued bimonthly.  USP subscribers have access to these publications and can send comments (within a 90-day post publication comment period) for consideration by the USP.  Finalized proposals (official revisions, new chapters, or monographs) are published in subsequent supplements to or editions of the Pharmacopeia.

References:

Date: 4/30/2009

Contact for further information:

CDER-OPQ-Inquiries@fda.hhs.gov

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-6821 .

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