GLP Analysis

What are Good Laboratory Practices (GLP) System, Scope, Purposes?

Good Laboratory Practice; It is the standard in which the planning, execution, reporting of general laboratory studies and related methods, processes and conditions are determined.

According to the scope of Good Laboratory Practices Guide:

- Purpose: To determine the principles for planning, conducting, monitoring, recording and reporting the studies of laboratories where studies will be carried out to provide data in terms of human health or environment and / or the properties of which should be determined. - Scope: This Guide covers the laboratory studies that constitute or anticipate the registration and permit applications of medical pharmaceutical products whose manufacture, import and sale are subject to the license or permission of the Ministry of Health, and the persons and organizations that have carried out these studies and It covers the workplaces and field studies.

Basic Principles:

- Quality Assurance System
- Laboratories Setup
- Sufficient Capacity and Proper Use of Devices
- Test and Reference Materials
- Working Procedures
- Reporting
- Records and Storage of Material

Laboratories that apply safety tests and analysis on pharmaceutical products, cosmetics, food and feed additives, pesticide products, veterinary drugs and industrial chemical materials can establish the "Good Laboratory Practices" system. Benefits of GLP:

- Ensuring the security of test data
- Prevention of retesting with mutual acceptance of data
- Time and cost savings

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