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Process Simulation / Media Fill
25-26 September 2008
Heidelberg, Germany
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Objectives
During this event, you will learn in lectures and workshops how to
plan a media fill in compliance with the cGMP requirements,
interpret the results of a media fill, and
investigate deviations and define follow-up measures.
Background
In the aseptic processing of medicinal products, the product quality usually cannot be ensured by means of lab controls of the final product. Process validation by means of media fills is the only way to furnish proof of product safety, which is why it justly is the focus of regulatory requirements and official inspections.
A number of revised international regulations, especially the FDA Guidance for Industry „Sterile Drug Products Produced by Aseptic Processing“, ISO 13408 and the PIC/S Guide „Recommendation on the Validation of Aseptic Processes“, define highly detailed requirements, the implementation of which is critically examined within the framework of official inspections. The new requirements concerning process simulation in Annex 1 of the EC GMP Guide published in February 2008 are now harmonised with the US-American requirements.
In general, the required media fills should be able to simulate both routine operation and worst-case conditions.
In practice, the question of practicability often arises. How should the requirements be interpreted and how can they be implemented even for special production processes or dosage forms?
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