[Federal Register Volume 66, Number 186 (Tuesday, September 25, 2001)]
[Notices]
[Pages 49028-49029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23980]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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://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, [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 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://www.fda.gov/cder/guidance/index.htm or 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