Quality assurance in contracted non-clinical safety studies subject to good laboratory practice regulations
✍ Scribed by Takeshi Hashizume
- Publisher
- John Wiley and Sons
- Year
- 1998
- Tongue
- English
- Weight
- 121 KB
- Volume
- 3
- Category
- Article
- ISSN
- 1087-8378
No coin nor oath required. For personal study only.
✦ Synopsis
To ensure the quality and reliability of data in a contracted non-clinical safety study subject to Good Laboratory Practice (GLP) regulations, the pharmaceutical manufacturer (sponsor) and the contract laboratory (contractor) must properly perform the duties and fulfil the responsibilities required by the regulations. Before employing a contract laboratory, the sponsor should carefully consider whether the study could be better performed in-house, as well as which contractor is most suitable for the job. Once a contract study has commenced, the sponsor and contractor should cooperate to inspect the test facilities and procedures, audit critical phases of the study, and take other appropriate quality assurance actions. In this paper, the most common requests made to sponsors by contractors are reviewed. In addition, inspections by the sponsor's quality assurance unit (QAU) are also discussed under the following headings: (1) justification, (2) qualification of inspectors, (3) objectives of inspections, (4) conduct of inspection, (5) reporting of inspection/audit findings and (6) considerations for inspections.