PIC_S人用制剂产品GDP指南-PI_047_1_PICS_GDP_人用药-2018年.pdf

PHARMACEUTICALINSPECTIONCONVENTION

PHARMACEUTICALINSPECTIONCO-OPERATIONSCHEME

PI047-1

Annex

1July2018

GUIDELINESONTHEPRINCIPLES

OFGOODDISTRIBUTIONPRACTICE

OFACTIVESUBSTANCES

FORMEDICINALPRODUCTS

FORHUMANUSE

©PIC/SJuly2018

Reproductionprohibitedforcommercialpurposes.

Reproductionforinternaluseisauthorised,

providedthatthesourceisacknowledged.

Editor:PIC/SSecretariat

e-mail:info@

website:

PI047-11of121July2018

TABLEOFCONTENTS

Page

Documenthistory3

Introduction3

1.Chapter1-Scope3

2.Chapter2-QualitySystem4

3.Chapter3-Personnel4

4.Chapter4-Documentation5

5.Chapter5-PremisesandEquipment6

6.Chapter6-Operations6

7.Chapter7-Returns,complaintsandrecalls8

8.Chapter8-Self-inspections10

RevisionHistory………………..10

Annex:Glossaryofterms11

PI047-12of121July2018

DOCUMENTHISTORY

TransposedbySCHfromECdocumentNovember2015–September2016

2015/C95/01

AdoptionbyCommitteeofPI047-11