(University of Bath)

Available in Windows and Web/Intranet Versions ISBN: 1 84211 006 3
Programmed by : Sarah-Louise Minter
Subject Specialist : Steve Moss

This package is intended to give an introduction to Good Manufacturing Practice (GMP) for medicinal products with respect to the Pharmaceutical Industry.


[Screenshot]
The package contains a total of 10 activity modules. The diagram above is a single screen from one of the activity modules.

Contents

  1. Introduction to GMP
  2. Quality Management
  3. Personnel
  4. Premises and Equipment
  5. Documentation
  6. Production
  7. Quality Control
  8. Contract Manufacture and Analysis
  9. Complaints and Product Recall
  10. Self Inspection


The package follows the pattern of information covered in "The Rules Governing Medicinal Products in the European Community Volume IV" as described in the publication by the Commission of the European Communities. This in turn reflects the information in "Rules and Guidance for Pharmaceutical Manufacturers" , Medicines Commission Agency (MCA) 1993, commonly known as the Orange Guide.

The level of information is aimed at undergraduate pharmacy students or for professional or technical employees in the pharmaceutical industry who have a requirement for a general understanding and training in GMP. It is not intended as sole source of training for individuals with a special responsibility for GMP.

Hardware and Software Requirements

Windows Version
The package is supplied on a CD-ROM Installation Disc and can be installed to a local hard disc or network drive. The minimum requirement is a PC with 100MHz Pentium processor , 8Mb of RAM and a VGA monitor capable of displaying 16-bit color (65, 536 colors) at 640 x 480 resolution. The program is 32-bit and is compatible with Windows 95, 98 and NT.
Web Version
The package is supplied on a CD-ROM Installation Disc for installation to a web server. The software runs on PC clients only. The minimum requirement is a 200MHz Pentium processor with 32Mb of RAM and a Super VGA monitor capable of displaying 16-bit color (65,536 colors) at 800 x 600 resolution. The program is compatible with both Netscape Navigator 4.x and Internet Explorer 4 or better and requires Java and Javascript to be enabled on browsers.