Pharmaceutical Packaging Systems - Part 1 Development

Im Auftrag der European Compliance Academy

Pharmaceutical Packaging Systems - Part 1 Development <p>Im Auftrag der European Compliance Academy

Vienna, Austria

Seminar Nr. 9351


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Jean-Francois Decoster
UCB Pharma, Belgium
Sandra Hafner
AbbVie Deutschland,Germany
Dr Gerald Kindermann
F. Hoffmann-La Roche, Switzerland
Torsten Kneuss
Bayer Pharma, Germany
Dr Karl Siemoneit
Sanofi, Germany
Dr Jörg Zürcher
Bayer Pharma, Germany


The focus of these 2 GMP Education Courses is on the development and routine control of pharmaceutical packaging systems.

In Course 1 participants will learn how to develop pharmaceutical packaging materials systematically, and how to translate the requirements of the Common Technical Document (CTD) to regulatory documents for packaging materials. Topics to be addressed include compendial standards, container closure integrity, and combination products.

Course 2 will focus on the testing of a variety of different packaging materials, as carried out in every incoming-goods laboratory in quality control. This includes the setting of sound and scientific specifications and Acceptable Quality Levels (AQLs), the control of dimensions, and the control of primary and secondary packaging materials.


There is a great number of regulatory requirements on pharmaceutical packaging materials, in the pharmacopoeias, the GMP regulations, in the FDA guidances, etc.
Packaging materials also have to be described in the registration process of a drug product according to the requirements of the CTD.

The development of pharmaceutical packaging systems is an increasingly complex topic, which is reflected in the most recent requirements for combination products. To cover all relevant aspects a thorough target product profile needs to be set up. Not only regulatory requirements drive container closure system development, also current hot topics such as container closure integrity and glass delamination need to be considered as well.

Furthermore, the pharmaceutical manufacturer has to guarantee that only such packaging materials are used that are correctly printed, in conformity with the specifications and in compliance with the regulatory requirements.

In order to determine the scope of the tests for the quality control of pharmaceutical packaging materials, the “Defect Evaluation Lists” have proved efficient. The responsibility for the tests lies now more and more with the manufacturers of packaging materials, while the pharmaceutical industry tries to reduce testing at the same time. However, as a precondition for this, additional QA measures, like supplier qualification, audits and supply agreements, have to be taken.


These GMP Education Courses are designed for employees working in pharmaceutical research and development, regulatory affairs, quality control, incoming goods control of packaging materials, and quality assurance departments. They are also of directed at employees of suppliers of primary and secondary packaging materials for the pharmaceutical industry.


Regulatory Requirements applicable to Pharmaceutical Packaging Materials
Code of Federal Regulations (CFR)
US Guidance for Industry: Container Closure Systems
EC Guidance: Plastic Immediate Packaging Materials
Jean-Francois Decoster, UCB Pharma

Glass Delamination
What is delamination
What is the route cause
Contribution to delamination
How to avoid
How to control
Dr Karl Siemoneit, Sanofi

Container Closure Integrity
Definition (Leakage)
Test methods
USP <1207>
Dr Jörg Zürcher, Bayer Pharma

Update of Compendial Standards
USP E&L <1663, 1664>?
Glass delamination – USP, Ph.Eur.
Rubber section JP
Ph.Eur. plastic materials
Jean-Francois Decoster, UCB Pharma

Packaging Related Topics of the Common Technical Document (CTD)
CTD structure (packaging related)
Translation of CTD requirements to Technical Regulatory Documents (TRD)
Best practice (blister and infusion bottle)
Dr Jörg Zürcher, Bayer Pharma

Development of Specifications for Container Closure Systems
Transforming a wish-list into a target profile
Conversion of a target profile into a specification
Critical parameters / acceptance criteria
Dr Jörg Zürcher, Bayer Pharma

Combination Products
Definitions and regulations
Development process
Dr Jörg Zürcher, Bayer Pharma

Shelf-life of Packaging Components
Why is a defined shelf-life required?
How to define the shelf-life for packaging components?
Re-Testing of packaging components
Torsten Kneuss, Bayer Pharma

Testing of Extractables/Leachables
Regulatory background
Principles of extractable and leachable testing
Potential extractables of different container materials
PQRI initiative on parenteral & ophthalmics
ICH genotoxic impurities vs. leachables values
Dr Jörg Zürcher, Bayer Pharma

Regulatory requirements
Equipment lifecycle qualification for the control of packaging materials
Process validation
Dr Gerald Kindermann, F. Hoffmann-La Roche


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