International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System; Availability, 38604-38605 [E7-13667]
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38604
Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0266]
International Conference on
Harmonisation; Draft Guidance on Q10
Pharmaceutical Quality System;
Availability
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Q10 Pharmaceutical Quality System.’’
The draft guidance was prepared under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 The draft guidance describes a
model for an effective quality
management system for the
pharmaceutical industry, referred to as
the Pharmaceutical Quality System. The
draft guidance applies to drug
substances and drug products, including
biotechnology and biological products,
throughout the product lifecycle. The
draft guidance is intended to provide a
comprehensive approach to an effective
pharmaceutical quality system that is
based on International Organization for
Standardization (ISO) concepts,
includes applicable good manufacturing
practice (GMP) regulations, and
complements the ICH guidances on ‘‘Q8
Pharmaceutical Development’’ and ‘‘Q9
Quality Risk Management.’’
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considers your comment on this draft
guidance before it begins work on the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
written or electronic comments on the
draft guidance by October 11, 2007.
ADDRESSES: Submit written comments
on the draft guidance to the Division of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.fda.gov/dockets/ecomments.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information (HFD–
240), 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
VerDate Aug<31>2005
19:05 Jul 12, 2007
Jkt 211001
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 selfaddressed adhesive labels to assist the
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the Guidance: Joseph C.
Famulare, Center for Drug
Evaluation and Research (HFD–
300), Food and Drug
Administration, 11919 Rockville
Pike, Rockville, MD 20852, 301–
827–8910; Christopher Joneckis,
Center for Biologics Evaluation and
Research (HFM–1), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301–
435–5681; or Diana Amador-Toro,
Office of Regulatory Affairs (HFRCE350), Food and Drug
Administration, 10 Waterview
Blvd., Parsippany, NJ 07054, 973–
331–4915.
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
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;
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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 IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In May 2007, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘Q10 Pharmaceutical Quality
System’’ 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.
The draft guidance provides guidance
on a comprehensive approach to an
effective pharmaceutical quality system
that is based on ISO concepts, includes
applicable GMP regulations, and
complements the ICH guidances on ‘‘Q8
Pharmaceutical Development’’ and ‘‘Q9
Quality Risk Management.’’ The draft
guidance describes a model for a
pharmaceutical quality system that can
be implemented throughout the
different stages of a product lifecycle.
The model demonstrates industry and
regulatory authorities’ support of an
effective pharmaceutical quality system
to enhance the quality, safety, and
availability of medicines around the
world in the interest of public health.
Implementation of the Pharmaceutical
Quality System throughout the product
lifecycle should facilitate innovation
and continual improvement, promote
the use of scientific and risk
management principles, and strengthen
the link between pharmaceutical
development and manufacturing
activities.
The draft guidance applies to drug
substances and drug products, including
biotechnology and biological products,
throughout the product lifecycle. Much
of the content of the draft guidance
applicable to manufacturing sites is
currently specified by regional GMP
requirements. The draft guidance is not
intended to create any new expectations
beyond current regulatory requirements.
Consequently, content of the guidance
that is additional to current GMP
requirements is optional.
E:\FR\FM\13JYN1.SGM
13JYN1
38605
Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Notices
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 to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft 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.fda.gov/ohrms/dockets/
default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/reading.htm.
Dated: July 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–13667 Filed 7–12–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Uniform Progress
Reports (OMB No. 0915–0061)—
Revision
The HRSA Uniform Progress Report
(UPR) is used for the preparation and
submission of continuation applications
Number of
respondents
Report
Responses
per
respondent
for Title VII and VIII health professions
and nursing education and training
programs. The UPR measures grantee
success in meeting (1) The objectives of
the grant project, and (2) the crosscutting outcomes developed for the
Bureau of Health Professions’ education
and training programs. Part I of the
progress report is designed to collect
information to determine whether
sufficient progress has been made on the
approved project objectives, as grantees
must demonstrate satisfactory progress
to warrant continuation of funding. Part
II collects information on activities
specific to a given program. Part III, the
Comprehensive Performance
Management System (CPMS), collects
data on overall project performance
related to the Bureau’s strategic goals,
objectives, outcomes, and indicators.
Progress will be measured based on the
objectives of the grant project, and
outcome measures and indicators
developed by the Bureau to meet
requirements of the Government
Performance and Results Act (GPRA).
The Bureau has simplified several
tables in UPR II and added the ability
for grantees to provide better race and
ethnicity data. In addition, to respond to
the requirements of GPRA, the Bureau
has revised its cross-cutting goals,
expected outcomes, and indicators in
UPR III CPMS that provide the
framework for collection of outcome
data for its Title VII and VIII programs.
An outcome based performance system
is critical for measuring whether
program support is meeting national
health workforce objectives. At the core
of the performance measurement system
are found cross-cutting goals with
respect to workforce quality, supply,
diversity, and distribution of the health
professions workforce.
The estimated annual burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
1,550
1
1,550
24
37,200
Total ..............................................................................
pwalker on PROD1PC71 with NOTICES
Uniform progress report .......................................................
1,550
........................
1,550
........................
37,200
VerDate Aug<31>2005
19:05 Jul 12, 2007
Jkt 211001
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
E:\FR\FM\13JYN1.SGM
13JYN1
]]>Agencies
[Federal Register Volume 72, Number 134 (Friday, July 13, 2007)]
[Notices]
[Pages 38604-38605]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13667]
[[Page 38604]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0266]
International Conference on Harmonisation; Draft Guidance on Q10
Pharmaceutical Quality System; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Q10 Pharmaceutical Quality
System.'' 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 draft guidance
describes a model for an effective quality management system for the
pharmaceutical industry, referred to as the Pharmaceutical Quality
System. The draft guidance applies to drug substances and drug
products, including biotechnology and biological products, throughout
the product lifecycle. The draft guidance is intended to provide a
comprehensive approach to an effective pharmaceutical quality system
that is based on International Organization for Standardization (ISO)
concepts, includes applicable good manufacturing practice (GMP)
regulations, and complements the ICH guidances on ``Q8 Pharmaceutical
Development'' and ``Q9 Quality Risk Management.''
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 written or electronic comments on the draft guidance
by October 11, 2007.
ADDRESSES: Submit written comments on the draft 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.fda.gov/dockets/ecomments. Submit written
requests for single copies of the draft guidance to the Division of
Drug Information (HFD-240), 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), 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. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the Guidance: Joseph C. Famulare, Center for Drug
Evaluation and Research (HFD-300), Food and Drug Administration, 11919
Rockville Pike, Rockville, MD 20852, 301-827-8910; Christopher
Joneckis, Center for Biologics Evaluation and Research (HFM-1), Food
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-
435-5681; or Diana Amador-Toro, Office of Regulatory Affairs (HFR-
CE350), Food and Drug Administration, 10 Waterview Blvd., Parsippany,
NJ 07054, 973-331-4915.
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 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 IFPMA, as well as observers from the World Health
Organization, Health Canada, and the European Free Trade Area.
In May 2007, the ICH Steering Committee agreed that a draft
guidance entitled ``Q10 Pharmaceutical Quality System'' 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.
The draft guidance provides guidance on a comprehensive approach to
an effective pharmaceutical quality system that is based on ISO
concepts, includes applicable GMP regulations, and complements the ICH
guidances on ``Q8 Pharmaceutical Development'' and ``Q9 Quality Risk
Management.'' The draft guidance describes a model for a pharmaceutical
quality system that can be implemented throughout the different stages
of a product lifecycle.
The model demonstrates industry and regulatory authorities' support
of an effective pharmaceutical quality system to enhance the quality,
safety, and availability of medicines around the world in the interest
of public health. Implementation of the Pharmaceutical Quality System
throughout the product lifecycle should facilitate innovation and
continual improvement, promote the use of scientific and risk
management principles, and strengthen the link between pharmaceutical
development and manufacturing activities.
The draft guidance applies to drug substances and drug products,
including biotechnology and biological products, throughout the product
lifecycle. Much of the content of the draft guidance applicable to
manufacturing sites is currently specified by regional GMP
requirements. The draft guidance is not intended to create any new
expectations beyond current regulatory requirements. Consequently,
content of the guidance that is additional to current GMP requirements
is optional.
[[Page 38605]]
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 to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft 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.fda.gov/ohrms/dockets/default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://www.fda.gov/cber/reading.htm.
Dated: July 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13667 Filed 7-12-07; 8:45 am]
BILLING CODE 4160-01-S
