Pharmaceutical Packaging Systems - Part 1 Development
Im Auftrag der ECA Academy

Pharmaceutical Packaging Systems - Part 1 Development Im Auftrag der ECA Academy

Budapest, Hungary

Seminar Nr. 16997


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Tel.: 06221 / 84 44 0 E-Mail:


Jean-Francois Decoster, UCB Pharma, Belgium
Torsten Kneuss, Bayer, Germany
Horst Koller, Member of Ph. Eur. Packaging Expert Groups at the EDQM | HK Packaging Consulting, Switzerland
Dr Jörg Zürcher, Chair of EDQM WP Glass, Bayer, 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 on, 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 directed at employees of suppliers of primary and secondary packaging materials for the pharmaceutical industry.


Part 1: Pharmaceutical Packaging Systems - Development
  • 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
Glass Delamination
  •  What is delamination
  •  What is the route cause
  •  Contribution to delamination
  •  How to avoid
  •  How to control
Container Closure Integrity (CCI)
  •  Definition (Leakage)
  •  Test methods
  •  USP <1207>
Update of Compendial Standards
  •  USP E&L <1663>, <1664>
  •  Glass delamination – USP, Ph.Eur.
  •  Rubber section JP, Elastomers USP <381>
  •  Ph.Eur. plastic materials, USP <661>, <665>
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)
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
Combination Products
  •   Definitions and regulations
  •   Development process
  •   Documentation
Update on Medical Devices and Drug-Device Combination Products/Medical Devices
  •  New EU regulation on Medical Devices and how to be prepared
  •  Other upcoming regulations and guidances for combination products
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
  •  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
End of Course 1 / Registration for Course 2


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