ECA 容器密封完整性测试指南Container Closure Integrity Testing of Medicinal Products for Parenteral Use-Positon Paper-Version 3
VIP免费
Foundation
Fostering harmonisation
ofGMP/GDP regulations
Container Closure Integrity Testing of
Medicinal Products for Parenteral Use
-Position Paper-
A document by the ECA Foundation
Version 3.0;November 2025
Container Closure Integrity Testing of Medicinal Products for
Parenteral Use
Foundation
Fostering harmonisation
ofGMP/GDPregulations
Table of Contents
DISCLAIMER............................................................................................................................................... 2
1 SCOPE................................................................................................................................................4
2 REGULATORY REQUIREMENTS...................................................................................................... 4
2.1 EuropeanCommissionandAnnex 1...............................................................................................4
2.2 American MarketandUSP<1207> andFDA Guidance Paper:................................................... 6
3 RECOMMENDATION FOR 100% CCI WITHIN PARENTERAL DRUG PRODUCT
PRODUCTION....................................................................................................................................6
4 RECOMMENDATION FOR CCI TESTING DURING THE SHELF-LIFE
STABILITY ASSESSMENT................................................................................................................10
5 REFERENCES.................................................................................................................................. 10
⑥Copyright: ECA Foundation, Germany - Copying, editing and distributing requirethe written agreement of theECA Foundation 1
3.1 CCI performed during Qualification/Validation (blue Figurela and 1b)
of a Drug Product/or a Filing Line................................................................................................ 8
3.2 CCI Methods used for Batch Release on a Sampling Basis(orangeFigure ia and 1b)............... 8
3.3 CCI Methodsused for Batch Releasebased on 100% Visual Inspection
(orangeFigure 1a and 1b)............................................................................................................ 8
3.4 Supplier Management fortheprimary Packaging Materials used (purple Fiqure 1)..................... 9
3.5 CCIVerificationwithin Stability Testing(back Fiqureia and 1b)............................................... 9
Container Closure Integrity Testing of Medicinal Products for
Parenteral Use
Container Closure Integrity Testing of Medicinal Products for Parenteral Use
Authors -Acknowledgements
This ECA Good Position Paper was developed by the Steering Committee of the ECA Visual
Inspection Working Group:
Dr Tobias Posset(Roche Diagnostics)
Dr Helmut Gaus(Winsol,formerly Boehringer Ingelheim)
Martin Dearden(M&F Quality Pharma Solutions Ltd)
Dr Martin Becker(formerly Baxter Oncology)
AI Goodwin(Amgen)
Christof Langer(OSConsulting)
Felix Krumbein(Head of ECA Inspection Group)
Version Changes
Version 1.0 New Document
Version 1.1 Minor editorial revision
Version 2.0 Addition:Annex 1 new requirement statement
Addition:CCI during shipping/transport validation
Removal:Microbiological Environmental Monitoring
Addition:Supplier Monitoring of primary packaging material
Version 2.1 Chapter 4.3:Stopper height of vials specified more precisely
Version 3.0 Update on Annex 1 requirements:original Annex 1 text and respective
interpretation
Inclusion of prefilled syringes in chapters 3 and 3.1
Addition of chapter 3.5 CCI Verification within Stability Testing
Technical Review
Klaus Feuerhelm(GMP Inspector,Germany)
Dr Robert Eicher(Concept Heidelberg)
Legal Representative
ECA Foundation
c/o VHP Auditing Firm and Legal Trustee
Attn Mr J.Ruland
Hebelstr.7
68161 Mannheim
Germany
Disclaimer
The information contained in this publication is provided for general informational and educational purposes
only.While every effort has been made to ensure the accuracy and completeness of the content,the
publisher and the authors assume no responsibility or liability for any errors,omissions,or inaccuracies.
This publication does not constitute legal,regulatory,or professional advice.Readers are encouraged to
consult the relevant regulations,guidelines,and competent authorities before making any decisions or
taking any actions based on the information provided herein.
⑥Copyright:ECA Foundation,Germany-Copying,editing and distributing require the written agreement of the ECA Foundation 2
摘要：
展开>>
收起<<
FoundationFosteringharmonisationofGMP/GDPregulationsContainerClosureIntegrityTestingofMedicinalProductsforParenteralUse-PositionPaper-AdocumentbytheECAFoundationVersion3.0;November2025ContainerClosureIntegrityTestingofMedicinalProductsforParenteralUseFoundationFosteringharmonisationofGMP/GDPregulati...
声明：如果您的权利被侵害，请联系我们的进行举报。
作者： 51zlzl
分类：专业资料
价格：100质量币
属性：11 页
大小：424.79KB
格式：PDF
时间：2025-11-25
