Guidance for Industry
Q7A Good Manufacturing
Practice Guidance for Active
Pharmaceutical Ingredients
. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
August 2001
ICH
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08/10/01
Guidance for Industry
Q7A Good Manufacturing
Practice Guidance for Active
Pharmaceutical Ingredients
Additional copies are available from:
Office of Training munications
Division munications Management
Drug Information Branch, HFD-210
5600 Fishers Lane
Rockville, MD 20857
(Tel) 301-827-4573
() r/guidance/
or
Office munication, Training and
Manufacturers Assistance, HFM-40
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448
: r/.
Fax: 1-888-CBERFAX or 301-827-3844
Mail: the Voice Information System at 800-835-4709 or 301-827-1800
. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
August 2001
ICH
Table Of Contents
I. INTRODUCTION (1) ........................................................................................................... 1
A. Objective ().................................................................................................................................1
B. Regulatory Applicability ().......................................................................................................2
C. Scope () .......................................................................................................................................2
II. QUALITY MANAGEMENT (2) ......................................................................................... 5
A. Principles ()...............................................
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