The first objective of this module is to identify and understand the key issues and GMP requirements relating to sterile product manufacture. This type of manufacturing is one of the most complex in the industry. The critical nature of the products in question make this a very important subject indeed.

The second objective is to review air classifications for activities related to the manufacture of sterile products.

The third is to review the different types of sterilisation methods and the forth is to review quality assurance aspects in the manufacture and control of sterile products

We shall also consider current issues applicable in your country.