91AV

Course Scope

This course has been designed specifically with trainee QP’s in mind as they need to ensure they understand the plethora of operations and challenges associated with Pharmaceutical Packaging. As the module includes a thorough look at all important aspects, it will also appeal to existing QPs wishing to update their knowledge.

In addition, it will also be of direct relevance and benefit to packaging supervisors/managers, quality personnel working in packing departments, packaging technologists and engineers supporting packing operations.

The QP needs to fully understand the challenges and risks involved in packaging operations in the Pharmaceutical Industry. A significant percentage of all product related complaints and recalls continue to be related to packaging issues. This course closely examines the key stages of pharmaceutical packaging relevant to the QP, from component manufacture and supply to final product release including QP certification.

This course will cover the main types and sources of micro-organisms and the issues associated with them in relation both sterile and non-sterile pharmaceutical production. Specific sessions will cover water systems, clean room design and operation, the concept of sterilisation and sterility assurance.

Learning Outcomes

By the end of the course you will:

• Have a good understanding of the various packaging materials used, their characteristics and how they are manufactured ??

• Appreciate the need to understand and work with suppliers of all packaging components; especially printed packaging components

• Understand the risks involved in packing operations and what the QP needs to be particularly aware of

• Gain practical information on how to improve the control of packing operations