6、WHO TRS 957 附录2：WHO有效药物成分的良好生产规范 -英文 -2010.pdf

©WorldHealthOrganization

WHOTechnicalReportSeries,No.957,2010

Annex2

WHOgoodmanufacturingpracticesforactive

pharmaceuticalingredients

1.Introduction

1.1Objective

1.2Regulatoryapplicability

1.3Scope

2.Qualitymanagement

2.1Principles

2.2Responsibilitiesofthequalityunit(s)

2.3Responsibilityforproductionactivities

2.4Internalaudits(self-inspection)

2.5Productqualityreview

3.Personnel

3.1Personnelqualifications

3.2Personnelhygiene

3.3Consultants

4.Buildingsandfacilities

4.1Designandconstruction

4.2Utilities

4.3Water

4.4Containment

4.5Lighting

4.6Sewageandrefuse

4.7Sanitationandmaintenance

5.Processequipment

5.1Designandconstruction

5.2Equipmentmaintenanceandcleaning

5.3Calibration

5.4Computerizedsystems

6.Documentationandrecords

6.1Documentationsystemandspecifications

6.2Equipmentcleaninganduserecord

6.3Recordsofrawmaterials,intermediates,APIlabelling

andpackagingmaterials

6.4Masterproductioninstructions(masterproduction

andcontrolrecords)

6.5Batchproductionrecords(batchproductionandcontrolrecords)

6.6Laboratorycontrolrecords

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6.7Batchproductionrecordreview

7.Materialsmanagement

7.1Generalcontrols

7.2Receiptandquarantine

7.3Samplingandtestingofincomingproductionmaterials

7.4Storage

7.5Re-evaluation

8.Productionandin-processcontrols

8.1Productionoperations

8.2Timelimits

8.3In-processsamplingandcontrols

8.4BlendingbatchesofintermediatesorAPIs