International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 4A on Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter; Availability, 15991-15992 [E9-7902]
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Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices
rwilkins on PROD1PC63 with NOTICES
a final draft of the guidance was
submitted to the ICH Steering
Committee and endorsed by the three
participating regulatory agencies in June
2008.
The ICH Q10 guidance provides
recommendations for a comprehensive
approach to an effective pharmaceutical
quality system that is based on ISO
concepts, includes applicable GMP
regulations and complements ICH ‘‘Q8
Pharmaceutical Development’’ and ‘‘Q9
Quality Risk Management.’’ The
guidance describes a model for a
pharmaceutical quality system that can
be implemented throughout the
different stages of a product lifecycle.
Much of the content of the guidance
applicable to manufacturing sites is
currently specified by regional GMP
requirements. The guidance is not
intended to create any new expectations
beyond current regulatory requirements.
The ICH Q10 guidance demonstrates
industry and regulatory authorities’
support of an effective pharmaceutical
quality system to enhance the quality
and availability of medicines around the
world in the interest of public health.
Implementation of the provisions of the
guidance throughout the product
lifecycle should facilitate innovation
and continual improvement and
strengthen the link between
pharmaceutical development and
manufacturing activities.
In 2006, FDA published a guidance
for industry entitled ‘‘Quality Systems
Approach to Pharmaceutical Current
Good Manufacturing Practice
Regulations’’ (October 2, 2006, 71 FR
57980). The 2006 guidance describes the
key elements of a robust quality systems
model and shows how implementation
of such a model is one way to comply
with FDA’s current good manufacturing
practice (CGMP) regulations. The 2006
guidance shows the correlation of ICH
Q10 quality system components to
FDA’s CGMP regulations.
The ICH Q10 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents 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 to the
Division of Dockets Management (see
ADDRESSES) written comments on the
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
VerDate Nov<24>2008
17:05 Apr 07, 2009
Jkt 217001
that individuals may submit one paper
copy. Comments are to be identified
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.
Dated: March 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–7875 Filed 4–7–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0396]
International Conference on
Harmonisation; Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex 4A on
Microbiological Examination of
Nonsterile Products: Microbial
Enumeration Tests General Chapter;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled ‘‘Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 4A: Microbiological
Examination of Nonsterile Products:
Microbial Enumeration Tests General
Chapter.’’ 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 provides the results
of the ICH Q4B evaluation of the
Microbiological Examination of
Nonsterile Products: Microbial
Enumeration Tests General Chapter
harmonized text from each of the three
pharmacopoeias (United States,
European, and Japanese) represented by
the Pharmacopoeial Discussion Group
(PDG). The guidance conveys
recognition of the three pharmacopoeial
methods by the three ICH regulatory
regions and provides specific
information regarding the recognition.
The guidance is intended to recognize
the interchangeability between the local
regional pharmacopoeias, thus avoiding
redundant testing in favor of a common
testing strategy in each regulatory
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
15991
region. In the Federal Register of
February 21, 2008 (73 FR 9575), FDA
made available a guidance on the Q4B
process entitled ‘‘Q4B Evaluation and
Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions.’’
DATES: Submit written or electronic
comments on agency guidance at any
time.
ADDRESSES: Submit written requests for
single copies of the 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 the
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. The
guidance may also be obtained by mail
by calling CBER at 1–800–835–4709 or
301–827–1800. Send two self-addressed
adhesive labels to assist the office in
processing your requests. Requests and
comments should be identified with the
docket number found in brackets in the
heading of this document. Submit
written comments on the guidance to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H.
King, Sr., Center for Drug Evaluation
and Research (HFD–003), Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4150,
Silver Spring, MD 20993–0002, 301–
796–1242; or Christopher Joneckis,
Center for Biologics Evaluation and
Research (HFM–25), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–0373.
Regarding the ICH: Michelle Limoli,
Office of International Programs (HFG–
1), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–4480.
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
E:\FR\FM\08APN1.SGM
08APN1
rwilkins on PROD1PC63 with NOTICES
15992
Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices
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, Labour,
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, Health Canada, and the
European Free Trade Area.
In the Federal Register of August 5,
2008 (73 FR 45463), FDA published a
notice announcing the availability of a
draft tripartite guidance entitled ‘‘Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 4A: Microbiological
Examination of Non-Sterile Products:
Microbial Enumeration Tests General
Chapter.’’ The notice gave interested
persons an opportunity to submit
comments by October 6, 2008.
After consideration of the comments
received and revisions to the guidance,
a final draft guidance entitled ‘‘Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 4A: Microbiological
Examination of Nonsterile Products:
Microbial Enumeration Tests General
Chapter’’ was submitted to the ICH
Steering Committee and endorsed by the
three participating regulatory agencies
in November 2008.
The guidance provides the specific
evaluation outcome from the ICH Q4B
process for the Microbiological
VerDate Nov<24>2008
17:05 Apr 07, 2009
Jkt 217001
Examination of Nonsterile Products:
Microbial Enumeration Tests General
Chapter harmonization proposal
originating from the three-party PDG.
This guidance is in the form of an annex
to the core ICH Q4B guidance. When
implemented, the annex will provide
guidance for industry and regulators on
the use of the specific pharmacopoeial
texts evaluated by the ICH Q4B process.
Following receipt of comments on the
draft, no substantive changes were made
to the annex.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents 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 to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the guidance. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/cder/guidance/index.htm,
or https://www.fda.gov/cber/
guidelines.htm.
Dated: March 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–7902 Filed 4–7–09; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0400]
International Conference on
Harmonisation; Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex 4C on
Microbiological Examination of
Nonsterile Products: Acceptance
Criteria for Pharmaceutical
Preparations and Substances for
Pharmaceutical Use General Chapter;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled ‘‘Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 4C: Microbiological
Examination of Nonsterile Products:
Acceptance Criteria for Pharmaceutical
Preparations and Substances for
Pharmaceutical Use General Chapter.’’
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 provides the results of the
ICH Q4B evaluation of the
Microbiological Examination of
Nonsterile Products: Acceptance
Criteria for Pharmaceutical Preparations
and Substances for Pharmaceutical Use
General Chapter harmonized text from
each of the three pharmacopoeias
(United States, European, and Japanese)
represented by the Pharmacopoeial
Discussion Group (PDG). The guidance
conveys recognition of the three
pharmacopoeial methods by the three
ICH regulatory regions and provides
specific information regarding the
recognition. The guidance is intended to
recognize the interchangeability
between the local regional
pharmacopoeias, thus avoiding
redundant testing in favor of a common
testing strategy in each regulatory
region. In the Federal Register of
February 21, 2008 (73 FR 9575), FDA
made available a guidance on the Q4B
process entitled ‘‘Q4B Evaluation and
Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions.’’
DATES: Submit written or electronic
comments on agency guidances at any
time.
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 74, Number 66 (Wednesday, April 8, 2009)]
[Notices]
[Pages 15991-15992]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7902]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0396]
International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 4A on
Microbiological Examination of Nonsterile Products: Microbial
Enumeration Tests General Chapter; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4A:
Microbiological Examination of Nonsterile Products: Microbial
Enumeration Tests General Chapter.'' 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 provides the results of the ICH Q4B evaluation
of the Microbiological Examination of Nonsterile Products: Microbial
Enumeration Tests General Chapter harmonized text from each of the
three pharmacopoeias (United States, European, and Japanese)
represented by the Pharmacopoeial Discussion Group (PDG). The guidance
conveys recognition of the three pharmacopoeial methods by the three
ICH regulatory regions and provides specific information regarding the
recognition. The guidance is intended to recognize the
interchangeability between the local regional pharmacopoeias, thus
avoiding redundant testing in favor of a common testing strategy in
each regulatory region. In the Federal Register of February 21, 2008
(73 FR 9575), FDA made available a guidance on the Q4B process entitled
``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in
the ICH Regions.''
DATES: Submit written or electronic comments on agency guidance at any
time.
ADDRESSES: Submit written requests for single copies of the 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 the 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. The guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send two self-addressed adhesive labels to assist the office in
processing your requests. Requests and comments should be identified
with the docket number found in brackets in the heading of this
document. Submit written comments on the guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H. King, Sr., Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002,
301-796-1242; or Christopher Joneckis, Center for Biologics Evaluation
and Research (HFM-25), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-0373.
Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4480.
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
[[Page 15992]]
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, Labour, 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, Health Canada, and the European Free Trade Area.
In the Federal Register of August 5, 2008 (73 FR 45463), FDA
published a notice announcing the availability of a draft tripartite
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 4A: Microbiological Examination
of Non-Sterile Products: Microbial Enumeration Tests General Chapter.''
The notice gave interested persons an opportunity to submit comments by
October 6, 2008.
After consideration of the comments received and revisions to the
guidance, a final draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 4A: Microbiological Examination of Nonsterile Products: Microbial
Enumeration Tests General Chapter'' was submitted to the ICH Steering
Committee and endorsed by the three participating regulatory agencies
in November 2008.
The guidance provides the specific evaluation outcome from the ICH
Q4B process for the Microbiological Examination of Nonsterile Products:
Microbial Enumeration Tests General Chapter harmonization proposal
originating from the three-party PDG. This guidance is in the form of
an annex to the core ICH Q4B guidance. When implemented, the annex will
provide guidance for industry and regulators on the use of the specific
pharmacopoeial texts evaluated by the ICH Q4B process. Following
receipt of comments on the draft, no substantive changes were made to
the annex.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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 to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance. Submit
a single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.regulations.gov, https://www.fda.gov/cder/guidance/index.htm,
or https://www.fda.gov/cber/guidelines.htm.
Dated: March 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7902 Filed 4-7-09; 8:45 am]
BILLING CODE 4160-01-S
