SMG 1262.41

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF COMPLIANCE

OFFICE OF MANUFACTURING AND PRODUCT QUALITY

DIVISION OF INTERNATIONAL DRUG QUALITY

Effective Date: 07/08/2011

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1. DIVISION OF INTERNATIONAL DRUG QUALITY (DKKNDAA)

A. Serves as the Compliance Branch for all international CGMP inspections, and oversees international drug quality and enforcement of adulteration provisions of the FD&C Act

B. Issues inspection requests and assignments that specify the inspectional emphasis and expertise needed to assure agency effectiveness

C. Conducts CGMP evaluations of foreign facilities referenced in pending applications, as well as other facilities shipping drug products to the US

D. Collaborates with other Office components in developing and implementing MOU and cooperation agreements with foreign governments

E. Prepares and identifies gaps, sets regulatory expectations for industry in the area of international quality and develops proactive strategies to reduce risk

2. INTERNATIONAL COMPLIANCE BRANCH 1 (DKKNDAA1)

A. Serves as the Compliance branch with primary responsibility for the oversight of overseas inspections of manufacturers, and focuses on review of potentially volatile inspection reports

B. Manages the compliance cases for international facilities to completion, including evaluating corrective actions and monitoring for lapses in compliance

C. Acts as CDER’s lead on international drug quality enforcement strategy, and serves as a liaison between other Office components, review divisions, and ORA

D. Monitors inspections and timeframes for NDAs/ANDAs/BLAs that include international manufacturing facility sites

3. INTERNATIONAL COMPLIANCE BRANCH 2 (DKKNDAA2)

A. Reviews inspection reports from international regulatory authorities to assist in determining facility status

B. Reviews and provides FDA inspection reports to assist counterpart regulatory authorities

C. Assists in the identification of strategic partnerships with foreign regulatory authorities

D. Conduct good manufacturing practice (GMP) inspections under bilateral agreements with foreign regulatory health authorities (i.e., API, finished product) for confidence building or to gain efficiencies

4. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Division were approved by the Secretary of the Department of Health and Human Services on July 8, 2011.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	05/20/2011	N/a	CDER/OM	Commissioner of Food and Drugs
Revision	07/08/2011	N/a	CDER/OM	Secretary of the Department of Health and Human Services