Prague, Czech Republic
Seminar Nr. 16541
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This education course deals with the development, manufacture, use and control of plastic packaging materials for medicinal products, medical devices and combination products. The course gives you an update on the regulatory requirements and shows you how these requirements can be put into practice. One of the focus topics is the use of additives as well as their testing and assessment by means of extractables/leachables studies. You also get the latest information on child-resistant packaging. And the course subjects are rounded off from a GMP compliance point of view with the topics testing of plastic packaging materials and handling of plastic packaging materials during packaging.
Requirements on the development, testing and registration of plastic packaging materials can among others be found in the EMA „Guideline on Plastic Immediate Packaging Materials“ of 2005 and the FDA Guidance for Industry „Container Closure Systems for Packaging Human Drugs and Biologics“.
The EMA guideline covers the specific requirements (data to be submitted) for plastic packaging materials intended to be in direct contact with the medicinal product. The guideline has to be applied in new registration applications or in variation applications.
According to the FDA guideline, each application should contain enough information to show that each proposed container closure system and its components are suitable for its intended use. This includes:
The education course is especially designed for members of staff and executives from the pharmaceutical industry working in the field of research and development, regulatory affairs, quality control, incoming goods control of packaging materials, quality assurance, production and packaging. It is also directed at employees of suppliers manufacturing plastic primary packaging materials for the pharmaceutical industry.
Plastic for Medical Packaging: Manufacturing of Materials and Devices