Drugs

Questions and Answers on Current Good Manufacturing Practices—General Provisions

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 CGMPs 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 CGMPs.

References:

 

Date: 6/14/2007

 

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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

 

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Contact for further information:

CDER-OPQ-Inquiries@fda.hhs.gov

 

 

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