Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices 15991 

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 

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 

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 http:// 

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 


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 

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 http:// 

www.regulations.gov, http:// 

www.fda.gov/cder/guidance/index.htm, 

or http://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 

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. 


rwilkins on PROD1PC63 with NOTICES