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Compliance Program For Eu Annex 1

A program was defined to generate robust packaging data throughout the product lifecycle to enable compliance with EU Annex 1 container closure requirements. The program comprehensively addresses regulatory and manufacturing concerns regarding container closure integrity through collaboration with experts. It provides a one-stop service model to validate closure methods, qualify packaging components and processes, and conduct testing to support transport and shipping.

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Dincer SELEN
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37 views2 pages

Compliance Program For Eu Annex 1

A program was defined to generate robust packaging data throughout the product lifecycle to enable compliance with EU Annex 1 container closure requirements. The program comprehensively addresses regulatory and manufacturing concerns regarding container closure integrity through collaboration with experts. It provides a one-stop service model to validate closure methods, qualify packaging components and processes, and conduct testing to support transport and shipping.

Uploaded by

Dincer SELEN
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Compliance Program for EU Annex 1

Container Closure Requirements•


The new EU GMP Annex 1 contains revised language for container closure
requirements

• Emphasis on appropriately • Increased attention to closure


validated methods during transport and shipping
• A container closure strategy that • Emphasis on generating data in
is science-based and data-driven a product life cycle approach

The requirements in the new EU GMP Annex 1 represent an evolution to


requiring a more robust science-based approach to container closure.
We have designed a program to generate statistically relevant packaging
data that enables compliance to regulatory requirements as well as
justification of a container closure integrity (CCI) testing strategy in a
holistic science-based approach.

A ROAD MAP WAS DEFINED FOR GENERATING ROBUST PACKAGING


DATA DURING THE PRODUCT LIFE CYCLE THAT ENABLES COMPLIANCE
TO EU ANNEX 1 REQUIREMENTS.
Clinical Batch CCIT
CCIT Headspace Method Development Stability CCIT
CCIT Headspace Method Validation Non-destructive headspace vacuum
maintenance measurements

Headspace gas ingress platforms for



Seal Quality Characterization
container closure integrity testing (CCIT)
Capping Line Optimization & Qualification
Primary Packaging Component Selection
Qualification of raised stopper detection
USP/EP Component Testing
CCI Validation for transport and shipping
Worst-case Dimensional Fit CCIT

PLEASE CONTACT [email protected] FOR SUPPORT


This flexible and scalable program
comprehensively addresses critical
regulatory and manufacturing
concerns regarding CCI, while
mitigating risks to the product,
business and, most importantly,
patient through collaboration with a
team of experts.

• A program for container closure designed to enable compliance to EU


Annex 1 requirements
• A one-stop-shop service model to ease administrative & quality vendor
requirements
• A program developed by the world’s leading experts who introduced the
headspace technology and methods currently used for container closure
integrity testing

ABOUT LIGHTHOUSE INSTRUMENTS


LIGHTHOUSE offers solutions for container closure integrity (CCI) testing, headspace oxygen monitoring, and
moisture determination of freeze-dried product, sterile powders and solid dosage forms. Lighthouse delivers non-
destructive laser-based headspace analysis platforms and analytical services to generate statistical process and
product data in all stages of the product life cycle. Lighthouse application experts have gained incredible amounts
of knowledge and expertise through their work with millions of finished sterile drug samples from pharmaceutical
facilities around the world. The goal is to use this knowledge and expertise to support clients in ensuring the
quality of your sterile products and processes.

Please contact us or visit our website for more information: www.lighthouseinstruments.com

Corporate Headquarters​ European Support Center​


Lighthouse Instruments, LLC​ Lighthouse Instruments B.V.​
2050 Avon Court​, Science Park 408​
Charlottesville, VA 22902​ 1098 XH Amsterdam, The Netherlands​
Telephone: +1 (434) 293-3081​ Telephone: +31 20 7051 050​
E-mail: [email protected]​​ E-mail: [email protected]

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