Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0558]

Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability

Agency

Food and Drug Administration, HHS.

Action

Notice.

Summary

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.

Dates

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 29, 2013.

Addresses

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448; or Communications Staff (HFV-12), Center for Veterinary Medicine (CVM), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See theSUPPLEMENTARY INFORMATIONsection for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For Further Information Contact

Paula Katz, Center for Drug Evaluation and Research, Bldg. 51, Rm. 4314, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6972; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210; or Jonathan Bray, Center for Veterinary Medicine (HFV-232),Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9228.

Supplementary Information

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” This draft guidance describes the FDA's current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to CGMP. Although written Quality Agreements are not explicitly required under existing CGMP regulations for human drugs and do not relieve any party to a contract of their responsibilities under CGMPs or under the Federal Food, Drug, and Cosmetic Act, this draft guidance explains how Owners and Contracted Facilities can draw on quality management principles to carry out the complicated process of contract drug manufacturing by defining, establishing, and documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support operations. In particular, this guidance describes FDA's recommendation that Owners and Contracted Facilities implement written Quality Agreements as a tool to delineate responsibilities and assure the quality, safety, and effectiveness of drug products.

We are considering including examples or references to examples of Quality Agreements in the guidance. Stakeholders are encouraged to provide specific comments on publicly available and useful Quality Agreements for contract arrangements for the manufacturing of drugs.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (seeADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. The Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and have been approved under OMB control numbers 0910-0014 and 0910-0001.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or http://www.regulations.gov.

Dated: May 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12539 Filed 5-24-13; 8:45 am]
BILLING CODE 4160-01-P
 
 
Comment Period Closed
Jul 29 2013, at 11:59 PM ET
ID: FDA-2013-D-0558-0001
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Document Information

Date Posted: May 28, 2013
Federal Register Number: 2013-12539
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Comments

27
Comments Received*
PDA commends FDA on writing this guidance which highlights common gaps which have occurred in the past between CMOs and Owners and clearly points out many...
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See attached file(s)

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