Publisher's Synopsis
This CD-ROM contains training modules on basic good manufacturing practices (GMP) such as material on general GMP for premises, equipment, materials, documentation, personnel, validation, and other aspects of quality assurance. It also contains supplementary training material covering validation, water systems, and heating, ventilation, and air conditioning (HVAC) systems, as well as the electronic version of the publication Quality assurance of pharmaceuticals: a compendium of guidelines and related materials volume 2 second updated edition. Good manufacturing practices and inspection (2007).
A training video showing the practical aspects of inspection and manufacturing, and demonstrating why these aspects are important is also included. The CD-ROM also contains an e-Course builder which is a tool for trainers and development practitioners to help them compose an HTML web-based course or training tool containing all selected chapters or sections or any number of documents from this CD-ROM or even combine these with other publications on the hard-disk into one single course or tool for training. The composed course can then be edited, adapted, exported in a PDF or HTML format, in order to use it as a training manual or curriculum for a course. The CD-ROM may also be useful as a self-study guide for the inspectors themselves or anyone else interested in the manufacture of quality medicines.
This package, which has been entirely updated, will be invaluable for those working towards the quality assurance of pharmaceuticals, both in the academic and private sectors.
