Quality Assurance in Preliminary Pharmacological Research: Improving Standards through Co-operation
✍ Scribed by Pascal André
- Publisher
- John Wiley and Sons
- Year
- 1997
- Tongue
- English
- Weight
- 87 KB
- Volume
- 2
- Category
- Article
- ISSN
- 1087-8378
No coin nor oath required. For personal study only.
✦ Synopsis
Implementing GLPs for the monitoring of non-clinical drug safety studies within the pharmaceutical industry is now well established, and the role of Quality Assurance (QA) within this framework is suitably defined. However, few guidelines have yet been established for the implementation of an appropriate quality system for preliminary pharmacological research, (i.e. those studies upon which decisions are based to proceed, or not, to full development). This article describes the 'Seven Step Approach' used for the implementation of a quality system at Servier. The system, based on GLP and ISO 9000 principles, places QA in a supportive rather than a verification role, and relies on co-operation between QA and scientific staff. By using, careful and considerate planning QA at Servier has implemented a quality system for preliminary research which works well, providing reliable data and concise, well-written reports upon which important decisions may be confidently made.