2024 虚拟培训马拉松工具包：促进疫苗生产机构合规与持续改进.pptxVIP

Advancinginstitutionalcomplianceandcontinuousimprovementin

vaccinemanufacturing

.VirtualTrainingMarathonkit2024

Acknowledgements

iv

Abbreviations

v

Introduction

1

Session1.Bio-analyticalmethoddevelopmentandvalidationICHQ2(R2)andICHQ14for

biologicals–Implementationandinspection-relatedconsiderations

Session2.Qualityriskmanagementframework–Aproactive,data-drivenandintegrated

approach

Session4.RoadmaptomaintainingandimprovingPpKviamonitoringandtrending

25

Session5.SterilemanufacturingTRS1044Annex2–Navigatingcomplexitiesandpractical

solutions

30

Session6.Technologytransfergranularities–Understandingessentialsandkeyactivitiesfor

biopharmaceuticals

36

Session7.ManagementofGXPoutsourcedactivities–Challengesandstrategiestosafeguard

yourprocess

42

Session8.MaintainingcompliantcriticalutilitiesfromURStoPQ

50

Session3.Processvalidationofbiologicals–Meetingcurrentregulatoryexpectations

Session9.CAPAandRCAinvestigationmanagement–Improvingeffectiveness

References

Session10.RecentcGMPinspectiontrends–Commonnon-compliancesandtypicalpitfalls

Contents

16

66

58

62

3

11

4

iii

AI

Artificialintelligence

Activepharmaceuticalingredient

MHRA

MedicinesandHealthcareRegulatory

APR

Agency

mRNA

Messengerribonucleicacid

Asepticprocess

NRA

Nationalregulatoryauthority

APS

Asepticprocesssimulation

APV

Asepticprocessvalidation

OPV

Ongoingprocessverification

ASTM

Biologicalindicator

oRABS

Openrestrictedaccessbarriersystem

BP

Batchprocess

BSL

Biologicalsafetylevel

PD

Processdevelopment

CAPA

Correctiveactionpreventiveaction

CCS

Contaminationcontrolstrategy

PPM

Primarypackagingmaterial

CFU

PPQ

Processperformancequalification

Criticalmaterialattribute

PQ

Performancequalification

CpK

Processcapabilityindex

CPP

Criticalprocessparameters

PV

Processvalidation

CPV

Criticalqualityattribute

QbD

Q