[Federal Register: September 25, 2001 (Volume 66, Number 186)]
[Notices]
[Page 49028-49029]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25se01-64]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1418]
International Conference on Harmonisation; Guidance on Good
Manufacturing Practice for Active Pharmaceutical Ingredients;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Q7A Good Manufacturing Practice
Guidance for Active Pharmaceutical Ingredients.'' The guidance was
prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The guidance describes current
good manufacturing practice (CGMP) for manufacturing of active
pharmaceutical ingredients (APIs). The guidance is intended to help
ensure that all APIs meet the standards for quality and purity they
purport or are represented to possess.
DATES: The guidance is effective September 25, 2001. Submit written or
electronic comments on agency guidances at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Drug Information Branch (HFD-210), Center for Drug Evaluation and
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857; or the Office of Communication, Training and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research
(CBER), 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-3844,
FAX 888-CBERFAX. Send two self-addressed adhesive labels to assist the
office in processing your requests. Submit written comments on the
guidance to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Requests and comments should be identified with the docket number found
in brackets in the heading of this document. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Edwin Rivera, Center for Drug Evaluation
and Research (HFD-320), Food and Drug Administration, 7520 Standish
Pl., Rockville, MD 20855, 301-594-0095, Rivera@cder.fda.gov, or John A.
Eltermann, Center for Biologics Evaluation and Research (HFM-670), Food
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-
827-3031, Eltermann@cber.fda.gov.
Regarding the ICH: Janet J. Showalter, Office of Health Affairs
(HFY-20), Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-827-0864.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission, the European Federation of Pharmaceutical Industries
Associations, the Japanese Ministry of Health and Welfare, the Japanese
Pharmaceutical Manufacturers Association, the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA, and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA). The ICH Steering Committee includes
representatives from each of the ICH sponsors and the IFPMA, as well as
observers from the World Health Organization, the Canadian Health
Protection Branch, and the European Free Trade Area.
In accordance with the agency's good guidance practices (GGPs)
regulation (21 CFR 10.115), this document is being called a guidance,
rather than a guideline.
To facilitate the process of making ICH guidances available to the
public, the agency has changed its procedures
[[Page 49029]]
for publishing ICH guidances. As of April 2000, FDA no longer includes
the text of ICH guidances in the Federal Register. Instead, the agency
publishes a notice in the Federal Register announcing the availability
of an ICH guidance. The ICH guidance is placed in the docket and can be
obtained through regular agency sources (see the ADDRESSES section).
Draft ICH guidances are left in the original ICH format. Final
guidances are reformatted to conform to the GGP style before
publication.
In the Federal Register of August 1, 2000 (65 FR 46936), FDA
published a notice announcing the availability of the draft guidance
entitled ``Q7A ICH Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients.'' The notice gave interested persons an
opportunity to submit comments by October 2, 2000.
After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in November 2000.
The guidance describes CGMPs for the manufacturing of APIs. The
guidance is intended to help ensure that all APIs meet the standards
for quality and purity they purport or are represented to possess. The
guidance is not intended to define registration or filing requirements
or modify pharmacopeial requirements.
In the guidance, ``manufacturing'' includes all operations, and
related controls, of receipt of materials, production, packaging,
repackaging, labeling, relabeling, quality control, release, storage,
and distribution of APIs. The guidance applies to the manufacture of
APIs for use in human drug products, including sterile APIs up to the
point immediately before the API is rendered sterile. The sterilization
and aseptic processing of sterile APIs are not covered by this
guidance. CGMP's described in the guidance should be applied to the API
manufacturing process beginning with the use of API starting materials.
The guidance applies to APIs that are manufactured by chemical
synthesis, extraction, cell culture/fermentation, recovery from natural
sources, or any combination of these processes. APIs manufactured using
blood or plasma as raw materials are also covered.
The guidance does not apply to vaccines, whole cells, whole blood
and plasma, blood and plasma derivatives (plasma fractionation), and
gene therapy APIs. The guidance does not apply to cell substrates,
medical gases, bulk-packaged drug products, and manufacturing/control
aspects specific to radiopharmaceuticals.
This guidance represents the agency's current thinking on CGMPs for
manufacturing APIs. 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 to the Dockets Management Branch
(address above) written or electronic comments on the guidance at any
time. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
draft guidance and received comments are available for public
examination in the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/publications.htm.
Dated: September 18. 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-23980 Filed 9-24-01; 8:45 am]
BILLING CODE 4160-01-S