Good laboratory practice pharmaceutical industry

Good laboratory practice (GLP) is a set of procedures within which the overall performance of a laboratory can be monitored. It is applicable to the organization and functioning of any laboratory but it is particularly relevant to the pharmaceutical industry. Compliance with GLP may be required for accreditation of a laboratory by an external regulating agency. 

In the pharmaceutical industry, it is important that aU products are properly tested and vahdated prior to release for sale. One of the most important tests is the determination of tablet dissolution rate. In this procedure tablets are immersed in a suitable medium to mimic the action of the stomach and the release of the active ingredients monitored over a period of time. Automation of these procedures is obviously important for various reasons including cost, accuracy of analysis and for validation of the results according to good laboratory practice. 

In the field of analytical chemistry and pharmaceutical formulations there is a growing awareness of quality issues. To mention a few. Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) and ISO norms are important topics in both laboratory and industrial environments. Moreover, there is a growing number of regulatory committees concerned with all aspects of quality, both on a national and international level [1-3]. 

Many countries with strong interests in chemicals, pesticides and pharmaceuticals and their trade started subsequently to adopt the OECD Principles of Good Laboratory Practice as the basis for safety testing in their industries. The European Union (then still named the European Community) also, by the Council Directive 67/18/EEC of 18 December 1986, formally adopted the OECD Principles, including them within its framework of guidelines governing the submission of safety data for the marketing of chemical substances. 

Unless specifically exempted by national legislation, these Principles of Good Laboratory Practice apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals. 

Anon (2004b) The harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances DIRECTIVE 2004/10/EC Anon (2005a) ICH guidance for industry - S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. http //www. fda.gov/... 

Quality Control Records. Accurate quality control records are of utmost importance and may be required by law, as in the pharmaceutical industry. A few years ago, mandatory Good Manufacturing Practices were proposed for the cosmetic industry. Although the proposal was later dropped, many manufacturers go by the rules worked out at that time for laboratory testing and record keeping. The food industry also requires extensive testing and record keeping. 

Good Practice for the use of computer systems in laboratory applications is now well established and is based on many years of experience. LIMS is simply another use of the power and flexibility of client/server or browser-accessed computerized systems. Therefore, it may be validated in a similar manner to other systems utilized within the pharmaceutical industry. Specifically, LIMS is... 

Good Manufacturing Practices for Pharmaceutical Facilities and Laboratories Ministries of Industry and Energy and Social Services... 

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