Pharmaceutical Packaging Systems - Part 1 Development & Part 2 Quality Control

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.