Pharmaceutical Packaging Systems - Part 1 - Development - Live Online Training

29/30 November 2022

Seminar-Nr. 20122


Dr. Katrin Buss

Dr. Katrin Buss

Quality Assessor

Torsten Kneuss

Torsten Kneuss


Dr Bettine Boltres

Dr Bettine Boltres

West Pharmaceutical Services

Note: All times mentioned are CET.


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 are 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 and sterile packaging materials (Annex 1 of the EU GMP Guide). To cover all relevant aspects a thorough target product profile needs to be set up. Not only regulatory requirements drive container closure system development, but also current challenges such as package integrity, glass delamination and particles on ready-to-sterilize (RTS) and ready-to-use (RTU) components.

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, 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 & sampling 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.

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Pharmaceutical Packaging Systems - Part 1 - Development - Live Online Training

Gesamtes Programm als PDF herunterladen

Day 1 - 29 November 2022
Regulatory Framework applicable to Pharmaceutical Packaging Materials
  • Code of Federal Regulations (CFR)
  • US Guidance for Industry: Container Closure Systems
  • EC Guidance: Plastic Immediate Packaging Materials
  • Compendial Standards (USP, Ph. Eur., JP)
Packaging Related Topics of the Common Technical Document (CTD)
  • CTD structure (packaging related)
  • Quality of components and materials
  • Declaration of compliance
  • Information to be provided in the dossier
Specific Aspects for Glass Materials
  • Ph. Eur. / USP
  • Extractable Elements
  • Sterilization
  • Critical Parameters
Q&A Session 1
Specific Aspects for Plastic Materials
  • Ph. Eur. / USP
  • Extractable Elements
  • Sterilization
  • Critical Parameters
Specific Aspects for Elastomeric Materials
  • Material background
  • Compendial compliance
  • Formulations and extractable elements
  • Sterilization
  • Critical Parameters
Extractables & Leachables
  • Regulatory background
  • Principles of extractable and leachable testing
  • Potential extractables & leachables
  • Case Studies
Q&A Session 2
Day 2 - 30 November 2022
Regulatory Expectations on Drug / Device Combinations
  • Medicinal products vs. medical devices
  • Legal requirements and scientific guidelines
  • Medicinal products with medical device part
Development of Drug/Device Combination Products
  • Regulatory Background
  • Design Control
  • Usability
  • Risk management
Container Closure Integrity (CCI)
  • Definition (Leakage)
  • Test methods
  • USP <1207>
  • Challenges & Solutions
Q&A Session 3

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Teilnehmerstimmen - das sagen andere über unsere Seminare:

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023


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