SMG 1262.43

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 GMP ASSESSMENT

Effective Date: 07/08/2011

[PDF Version]

	1. Division of GMP Assessment
	2. Biotech Manufacturing Assessment Branch
	3. New Drug Manufacturing Assessment Branch
	4. Generic Drug Manufacturing Assessment Branch
	5. Authority and Effective Date

1. DIVISION OF GMP ASSESSMENT (DKKNDAD)

A. Participates on CDER review team and committees for applications, amendments, and supplements

B. Serves as liaison between CDER review divisions and ORA field offices

C. Conducts CGMP evaluations of establishments referenced in applications

D. Issues pre-approval inspection (PAI) and for-cause inspection requests, including specific Center recommendations for inspectional focus (i.e. knowledge transfer)

E. Monitor inspection timeframes, reviews PAI reports for domestic firms, and evaluates recommendations for all pending applications

F. Provides technical assistance for PAI inspections and guidance on CGMP and process feasibility to manufacturers, ORA, Centers, and Agency

G. Performs CMC review for Biologics License Applications (BLA) and supplements (sBLA), conducts pre-approval inspections, and provides technical expertise for biological therapeutic products

H. Meets with regulated industry and sponsors of NDA/ANDA/BLAs

I. Provides support for regulatory actions involving drug product quality requirements, including determining facility acceptability and leading the Center’s evaluation of recommendations relating to the application integrity policy

2. BIOTECH MANUFACTURING ASSESSMENT BRANCH (DKKNDAD1)

A. Performs CMC review for Biologics License Applications (BLA) and supplements focusing on areas relevant to manufacturing controls, with emphasis on facilities, product packaging integrity, cross-contamination prevention, microbiology product quality, and sterility assurance of biotech drugs

B. Leads pre-approval inspections of establishments manufacturing biological therapeutic products for BLA and BLA supplements

C. Serves as the technical experts in biotech drug manufacturing and controls

D. Provides guidance to manufacturers, ORA, Center and Agency on CGMP for biological therapeutic products

E. Participates in licensing committees for biological license applications, amendments, and BLA supplements, and meets with regulated industry and sponsors of BLA products to address scientific or regulatory issues involved in license applications

3. NEW DRUG MANUFACTURING ASSESSMENT BRANCH (DKKNDAD2)

A. Participates in committees for new drug applications, amendments, and NDA supplements, and contributes to CMC review of New Drug Applications (NDAs) and supplements

B. Serves as the agency focal point and provides guidance to manufacturers, ORA, Centers, and Agency on compliance of establishments and products with CGMP and other adulteration provisions of the Federal Food, Drug and Cosmetic Act as it pertains to NDA products

C. Acts as lead on pre-market evaluation of scale-up, process control, process and facility suitability, production engineering, written procedures, and other aspects of CGMP

D. Provides pre-market support on manufacturing or control approaches, including leading inspectional evaluations of advanced or novel technological or validation approaches

E. Identifies new drug products or facilities that need follow-up under post-approval compliance programs

4. GENERIC DRUG MANUFACTURING ASSESSMENT BRANCH (DKKNDAD3)

A. Serves as the Agency focal point regarding generic drug establishments, and identifies generic human drug products or facilities that need follow-up under post-approval compliance programs

B. Assures rapid access to quality new human drugs by verifying abbreviated new drug application (ANDA) commitments, CGMP compliance, and submission of supporting data before and after application approval; and develops and implements strategies for alleviation of drug shortages/drug supply problems

C. Serves as CDER's contact for manufacturing and product quality issues related to generic drug products, and assists Biotech Assessment Branch on biosimilars

D. Assists in preparing for generic drug inspections, provides technical assistance during the inspections, and advises on regulatory decisions following the inspections

E. Provides clear and consistent guidance to FDA field personnel, industry and foreign governments on manufacturing and product quality requirements for generic human drug products

5. 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