行业质量体系在药品CGMP法规方面的指导原则
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Guidance for Industry
Quality Systems Approach to
Pharmaceutical CGMP Regulations
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
Office of Regulatory Affairs (ORA)
September 2006
Pharmaceutical CGMPs
Guidance for Industry
Quality Systems Approach to
Pharmaceutical CGMP Regulations
Additional copies are available from:
Office of Training and Communication
Division of Drug Information, HFD-240
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
(Tel) 301-827-4573
http://www.fda.gov/cder/guidance/index.htm
or
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
http://www.fda.gov/cber/guidelines.htm.
(Tel) 800-835-4709 or 301-827-1800
or
Communications Staff, HFV-12
Center for Veterinary Medicine
Food and Drug Administration
7519 Standish Place, Rockville, MD 20855
(Tel) 301-827-3800
http://www.fda.gov/cvm/guidance/published.html
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
Office of Regulatory Affairs (ORA)
September 2006
Pharmaceutical CGMP Regulations
Contains Nonbinding Recommendations
TABLE OF CONTENTS
I. INTRODUCTION............................................................................................................. 1
II. BACKGROUND AND PURPOSE.................................................................................. 1
A. Background ....................................................................................................................................1
B. Goal of the Guidance.....................................................................................................................2
C. Scope of the Guidance ...................................................................................................................3
D. Organization of this Guidance......................................................................................................4
III. CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS................... 4
A. Quality.............................................................................................................................................4
B. Quality by Design and Product Development .............................................................................4
C. Quality Risk Management ............................................................................................................5
D. CAPA (Corrective and Preventive Action)..................................................................................5
E. Change Control..............................................................................................................................5
F. The Quality Unit ............................................................................................................................5
G. Six-system Inspection Model.........................................................................................................6
IV. THE QUALITY SYSTEMS MODEL............................................................................. 8
A. Management Responsibilities .......................................................................................................8
1. Provide Leadership..........................................................................................................................8
2. Structure the Organization ..............................................................................................................9
3. Build Your Quality System to Meet Requirements...........................................................................9
4. Establish Policies, Objectives, and Plans.....................................................................................10
5. Review the System..........................................................................................................................10
B. Resources......................................................................................................................................12
1. General Arrangements...................................................................................................................12
2. Personnel Development .................................................................................................................13
3. Facilities and Equipment...............................................................................................................13
4. Control Outsourced Operations ....................................................................................................14
C. Manufacturing .............................................................................................................................15
1. Design, Develop, and Document Product and Processes..............................................................15
2. Examine Inputs ..............................................................................................................................16
3. Perform and Monitor Operations..................................................................................................17
4. Address Nonconformities...............................................................................................................19
D. Evaluation Activities....................................................................................................................21
1. Analyze Data for Trends...............................................................................................................21
2. Conduct Internal Audits.................................................................................................................21
3. Quality Risk Management..............................................................................................................22
4. Corrective Action...........................................................................................................................22
摘要：
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GuidanceforIndustryQualitySystemsApproachtoPharmaceuticalCGMPRegulationsU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)OfficeofRegulatoryAffairs(ORA)September2006Pharm...
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作者：冒牌货
分类：专业资料
价格：60质量币
属性：32 页
大小：362.89KB
格式：PDF
时间：2025-12-04
