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Risk Management in Sterile Manufacturing AND
Process Simulation/Media Fill
Save up to 400 EUR and book both courses!
23-26 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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Risk Management in Sterile Manufacturing, 23-24- September 2008
Learning Goals
Why you should attend this course:
- You get to know the methods of risk analysis and learn how to apply them to the specific questions of sterile manufacturing,
- You can distinguish between critical and uncritical risks and accordingly define measures for controlling these risks ,
- In workshops, you analyse sterile processes, assess possible risks and suggest suitable countermeasures.
Background
The manufacture of sterile medicinal products is a risk-prone process. Whereas the product safety of terminally sterilised products can usually be ensured by validating the sterilisation process, aseptic manufacture makes great demands on process safety. As early as 2001, the FDA had defined the „Risk-Based Approach“ for future inspections; involving high risk in the sense of the authority‘s definition and therefore being automatically in the focus of inspections is „aseptic processing“.
Even in advance, one has to study the question whether each process step poses a contamination risk, and if so, which one. Good risk management consists in identifying and assessing risks in time and taking measures in the production process in order to control or – if possible – eliminate these risks.
Everyday routine confronts us with a multitude of potential risks. Which of them are critical, which ones rather uncritical? How can risk assessment be done and which rationales play a role in this decision?
The speakers provide you with practice-oriented approaches to assessing, controlling and reducing risks in „sterile processes“ and to get safely through inspections.
Process Simulation/Media Fill, 25-26 September 2008
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 from Annex 1 to 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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