| Good Manufacturing Practice v2.0 |
| Source | PCCAL, University of Bath |
| ISBN: | ISBN: 1 84211 006 3 |
| Versions Available | Internet |
| Programmer | Sarah-Louise Minter |
| Subject Specialist | Steve Moss |
| Summary | |
![[Screenshot]](GMP.gif) Screen shot from the package |
This package is intended to give an introduction to
Good Manufacturing Practice (GMP) for medicinal products with respect
to the Pharmaceutical Industry. 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. |
| Contents |
Introduction to GMP |
| Quality Management |
| Personnel |
| Premises and Equipment |
| Documentation |
| Production |
| Quality Control |
| Contract Manufacture and Analysis |
| Complaints and Product Recall |
| Self Inspection |