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

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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

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