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

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

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

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标签： #质量体系 #CGMP #GMP

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GuidanceforIndustryQualitySystemsApproachtoPharmaceuticalCGMPRegulationsU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)OfficeofRegulatoryAffairs(ORA)September2006Pharm...

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