Contains the full lesson along with a supporting toolkit, including teachers’ notes.
Scientific principles apply throughout industry, even in areas which on the surface may appear straightforward. Companies such as Genzyme (a Sanofi company) producing biotechnical and pharmaceutical treatments, must ensure that these are delivered in a safe manner to patients. Many such treatments are in liquid or powder form and are stored in a vial. A vial is a small vessel, often made of glass. It is critically important that these vials are free from any microbiological contamination. In this lesson, we outline some of the industrial processes involved and also look at the IT systems that support these processes.
The company have installed a second state-of-the-art production line into their facility in Waterford. This modern equipment will be used to automatically transfer the formulated drug products into vials for delivery to patients. In Genzyme, the process of filling and sealing vials is known as ‘fill and finishing’.
This new modern production line (called ‘Line 2’) required several years of planning which resulted in the Validation Master Plan (VMP).
What is the Validation Master Plan (VMP)?
Since all the cost and effort in manufacturing is wasted if contamination is introduced at the vial-filling stage, a comprehensive programme is needed to ensure that everything is in place to the highest specification. The validation master plan (VMP) does this and is an essential part of project management. In particular, it ensures that criteria for good manufacturing practice are met in accordance with US and European regulations. The VMP addresses all activities related to the project, including impact statements, design reviews, factory construction and standard operating procedures (SOPs).
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