Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 59255

• The written policies and procedures 

established to ensure that contractors 

conform to the same requirements (e.g., 

education, training, and experience) that 

would apply to the applicant if it were 

performing the inspection or aspects of 

the inspection contracted. These 

policies and procedures should ensure 

that the contractor conducts inspections 

in accordance with the same procedures 

under which the applicant operates. The 

applicant should include assurances 

that it will maintain documentary 

evidence that the contractor has the 

necessary technical competence and 

resources to carry out contracted 

activities;

• Written policies and procedures 

documenting that the applicant will not 

contract the overall responsibility for 

reviewing the results of the inspections;

• Documentation of an agreement 

delineating the duties, responsibilities, 

and accountability of the contractor; and

• The written policies and procedures 

for establishing a register of qualified 

contractors.

AP QS

FDA will consider the following 

factors to determine whether the 

applicant has established an adequate 

quality system to ensure compliance 

with FDA policies and procedures 

relevant to inspections:

• The applicant should establish a 

documented quality system to ensure 

that there are processes and procedures 

in place to demonstrate compliance 

with section 704(g) of the act;

• The policies and procedures the 

applicant follows are adequate to 

maintain control of all quality system 

documentation and to ensure that a 

current version is available at all 

locations; and

• The policies and procedures for 

internal auditing to ensure the quality 

system is implemented effectively and 

that resources are available for 

conducting such audits.

Certification Agreement Statement

The applicant should provide a copy 

of a documented statement, which will 

be signed by the most responsible 

individual, certifying that:

• The AP has appropriate policies and 

procedures to meet FDA’s conflict of 

interest provisions, has the appropriate 

staff and procedures in place to ensure 

technical competence for conducting 

inspections under section 704(g) of the 

act, and has the quality system in place 

to ensure acceptable and consistent 

inspections;

• Where the AP uses the services of 

a contractor for QS/GMP inspections, 

the AP should also certify that its 

contractor(s) meets the APs established 

criteria for freedom from conflicts of 

interest and technical competence;

• The AP consents to FDA inspection 

and copying of all records, 

correspondence, and other materials 

relating to any inspections conducted by 

the AP under this program, including 

records on personnel, education, 

training, skills, and experience and all 

documentation on prevention of 

conflicts of interest, including 

certification/compliance statements; 

and

• The AP will protect trade secret and 

confidential commercial or financial 

information, and will treat as private 

information about specific patient 

identifiers in records such as adverse 

event reports, except that such 

information may be made available to 

FDA.

III. The Guidance

We are issuing a revised guidance 

entitled ‘‘Implementation of the 

Inspection by Accredited Persons 

Program Under the Medical Device User 

Fee and Modernization Act of 2002; 

Accreditation Criteria,’’ which repeats 

the AP criteria set out in section II of 

this document. In addition, the 

guidance provides other useful 

information such as suggestions about 

the format and content of the 

accreditation applications. The revised 

guidance reflects changes to the law 

made by the Medical Device Technical 

Corrections Act.

The guidance represents the agency’s 

current thinking on the 

‘‘Implementation of the Inspection by 

Accredited Persons Program under the 

Medical Device User Fee and 

Modernization Act of 2002; 

Accreditation Criteria.’’ The issuance of 

this guidance is consistent with FDA’s 

good guidance practices regulation (21 

CFR 10.115). 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.

IV. Electronic Access

To receive ‘‘Implementation of the 

Inspection by Accredited Persons 

Program Under the Medical Device User 

Fee and Modernization Act of 2002; 

Accreditation Criteria’’ by fax machine, 

call the CDRH Facts-On-Demand system 

at 800–899–0381 or 301–827–0111 from 

a touch-tone telephone. Press 1 to enter 

the system. At the second voice prompt, 

press 1 to order a document. Enter the 

document number (1200) followed by 

the pound sign (#). Follow the 

remaining voice prompts to complete 

your request.

Persons interested in obtaining a copy 

of the guidance may also do so by using 

the Internet. CDRH maintains an entry 

on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http://

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/

ohrms/dockets.

V. Paperwork Reduction Act of 1995

This document and the guidance 

entitled ‘‘Implementation of the 

Inspection by Accredited Persons 

Program Under the Medical Device User 

Fee and Modernization Act of 2002; 

Accreditation Criteria’’ contain a 

proposed collection of information that 

requires clearance by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). The 

collections of information addressed in 

the guidance document have been 

approved by OMB in accordance with 

the PRA under OMB control number 

0910–0510.

VI. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this guidance 

document at any time. Submit 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. Comments received may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday.

Dated: September 24, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22211 Filed 10–1–04; 8:45 am]

BILLING CODE 4160–01–S

59256 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0443]

Draft Guidance for Industry on Quality 

Systems Approach to Pharmaceutical 

Current Good Manufacturing Practice 

Regulations; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Quality Systems 

Approach to Pharmaceutical Current 

Good Manufacturing Practice 

Regulations.’’ The draft guidance 

describes the key elements of a robust 

quality systems model and shows how 

persons implementing such a model can 

achieve compliance with the CGMP 

regulations.

DATES: Submit written or electronic 

comments on the draft guidance by 

December 3, 2004. General comments 

on agency guidance documents are 

welcome at any time.

ADDRESSES: 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, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

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 http://

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Monica Caphart, Center for Drug 

Evaluation and Research (HFD–

320), Food and Drug 

Administration, 11919 Rockville 

Pike, Rockville, MD 20852, 301–

827–9047; or

Robert Sausville, Center for Biologics 

Evaluation and Research (HFM–

624), Food and Drug 

Administration, 1401 Rockville 

Pike, Rockville, MD 20852–1448, 

301–827–6201; or

June Liang, Center for Veterinary 

Medicine (HFV–12), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–

8789; or

Patricia Maroney-Benassi, Office of 

Regulatory Affairs (HFC–240), 

15800 Crabbs Branch Way, 

Rockville MD 20855, 240–632–

6819.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Quality Systems Approach to 

Pharmaceutical Current Good 

Manufacturing Practice Regulations.’’

The draft guidance illustrates where 

FDA can harmonize across agency 

centers and with other non-U.S. 

pharmaceutical quality management 

requirements. This draft guidance was 

developed by the quality systems group 

formed as part of the CGMP for the 21st 

Century initiative. The draft guidance is 

intended to encourage the use of 

modern quality management system 

principles by the regulated industry and 

foster innovation and continuous 

improvements in pharmaceutical 

manufacturing.

The Pharmaceutical CGMPs for the 

21st Century: A Risk Based Approach 

initiative was announced in August 

2002 (http://www.fda.gov/cder/gmp/

2ndProgressReptlPlan.htm). Among 

the many CGMP issues identified at that 

time were: (1) The increase in the 

number of pharmaceutical products and 

in the role of medicines in health care; 

(2) the decrease in the frequency of FDA 

manufacturing inspections resulting 

from fewer available resources; (3) 

FDA’s increasing experience with, and 

lessons learned from, various 

approaches to the regulation of product 

quality; (4) advances in the 

pharmaceutical sciences and 

manufacturing technologies; (5) the 

increasing application of biotechnology 

in drug discovery and manufacturing; 

(6) advances in the science and 

management of quality; and (7) the 

globalization of the pharmaceutical 

industry.

At the outset, the agency established 

a set of guiding principles for the 

initiative:

• Maintain a risk-based orientation;

• Policies and standards must be 

science based;

• The agency’s orientation must be 

toward integrated quality systems;

• International cooperation is very 

important; and

• Protection of the public health must 

remain top priority.

The initiative’s announcement stated 

that 21 CFR parts 210, 211, and parts 

600 and 610 are flexible and will allow 

the agency to embark on a science-based 

risk management approach to CGMPs. 

This draft guidance, developed by a 

cross-center working group established 

by the initiative, is key in achieving the 

agency’s goals. By showing how modern 

quality systems approaches relate to the 

existing CGMP regulation, the agency 

can help manufacturers meet the 

requirements of the agency’s CGMP 

while using a robust quality systems 

approach to the production of human 

and animal medical products. Such a 

comprehensive approach should foster 

flexibility and allow for continued 

innovation, while maintaining the 

principles of the CGMP regulations.

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. Two 

paper copies of mailed comments are to 

be submitted, 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. The draft 

guidance and received comments are 

available for public examination 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 either http:/

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

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: September 28, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22206 Filed 9–29–04; 1:51 pm]

BILLING CODE 4160–01–S