[Federal Register Volume 65, Number 148 (Tuesday, August 1, 2000)]
[Notices]
[Pages 46936-46937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19332]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1418]


International Conference on Harmonisation; Draft Guidance on Good 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availability of a draft guidance entitled ``Q7A ICH Good Manufacturing 
Practice Guide for Active Pharmaceutical Ingredients.'' The draft 
guidance was prepared under the auspices of the International 
Conference on Harmonisation of Technical Requirements for Registration 
of Pharmaceuticals for Human Use (ICH). The document is intended to 
provide guidance regarding current good manufacturing practice (CGMP) 
for manufacturing of active pharmaceutical ingredients (API's). The 
recommendations in the draft guidance are intended to assist in the 
manufacture of API's that meet the standards for quality and purity 
they purport or are represented to possess.

DATES: Submit written comments by October 2, 2000.

ADDRESSES: Copies of the draft guidance are available on the Internet 
at http://www.fda.gov/cder/guidance/index.htm. Submit written requests 
for single copies of the draft guidance to the Drug Information Branch 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.
    To facilitate the submission and review of comments on this draft 
guidance, the agency has developed two methods for submitting 
electronic comments. Interested persons may submit comments to the 
Dockets Management Branch (HFA-305) online or offline by downloading a 
comments template. Both methods are accessible on the FDA web site at 
http://www.fda.gov/ohrms/dockets. The agency encourages the submission 
of electronic comments and anticipates that widespread use of these 
methods

[[Page 46937]]

will increase the effectiveness of the guidance development process.
    Interested parties may also submit written comments on the draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance:
    Joseph X. Phillips, Central Regional Office, U.S. Customhouse, 2d 
and Chestnut Sts., rm. 900, Philadelphia, PA 19106, 215-597-0492, 
[email protected], or
    Edwin Rivera, Center for Drug Evaluation and Research (HFD-320), 
Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 
301-594-0095, [email protected], 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, [email protected].
    Regarding the ICH: Janet J. Showalter, Office of International 
Programs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0864.

SUPPLEMENTARY INFORMATION: 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 July 2000, the ICH Steering Committee agreed that a draft 
guidance entitled ``Q7A ICH Good Manufacturing Practice Guide for 
Active Pharmaceutical Ingredients'' should be made available for public 
comment. The draft guidance is the product of the Quality Expert 
Working Group of the ICH. Comments about this draft will be considered 
by FDA and the Quality Expert Working Group.
    In accordance with FDA's good guidance practices (GGP's) (62 FR 
8961, February 27, 1997), 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 is changing its procedure for publishing ICH 
guidances. Beginning April 2000, we will no longer include the text of 
ICH guidances in the Federal Register. Instead, we will publish a 
notice in the Federal Register announcing the availability of an ICH 
guidance. The ICH guidance will be placed in the docket and can be 
obtained through regular agency sources (see the ADDRESSES section). 
The draft guidance will be left in the original ICH format. The final 
guidance will be reformatted to conform to the GGP style before 
publication.
    The draft guidance describes CGMP for the manufacturing of API's. 
The recommendations in the draft guidance are intended to assist in the 
manufacture of API's that meet the standards for quality and purity 
they purport or are represented to possess. The draft guidance is not 
intended to define registration or filing requirements or modify 
pharmacopeial requirements.
    In the draft guidance, ``manufacturing'' includes all operations, 
and related controls, of receipt of materials, production, packaging, 
repackaging, labeling, relabeling, quality control, release, storage, 
and distribution of API's. The draft guidance applies to the 
manufacture of API's for use in human drug products, including sterile 
API's up to the point immediately before the API is rendered sterile. 
The sterilization and aseptic processing of sterile API's are not 
covered by this draft guidance. CGMP's described in the draft guidance 
should be applied to the API manufacturing process beginning with the 
use of starting materials.
    The draft guidance applies to API's that are manufactured by 
chemical synthesis, extraction, cell culture/fermentation, recovery 
from natural sources, or any combination of these processes. 
Intermediates and API's produced by recombinant DNA technology are 
covered provided they are proteinacious materials.
    The draft guidance does not apply to vaccines, whole cells, whole 
blood and plasma, and API's derived from plasma fractionation, but does 
apply to API's produced using blood or plasma as raw materials. The 
draft guidance does not apply to cell substrates, medical gases, bulk-
packaged drug products, and manufacturing/control aspects specific to 
radiopharmaceuticals.
    This draft guidance represents the agency's current thinking on 
CGMP's for manufacturing of API's. 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, regulations, or both.
    Interested persons may submit electronic comments to the Dockets 
Management Branch (http://www.fda.gov/ohrms/dockets) by October 2, 
2000. Written comments also can be submitted on the draft guidance 
(address above). 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 may be seen in the 
office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 26, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-19332 Filed 7-27-00; 1:45 pm]
BILLING CODE 4160-01-F