Good Laboratory Practices development

As vith human pharmaceuticals, all safety studies must be conducted in accordance vdth the principles of Good Laboratory Practice (GLP). Similar to the International Conference on Harmonisation (ICH), the Veterinary International Conference on Harmonisation (VICH) has developed agreed guidelines on the types of test and other considerations that need to be addressed during the development and evaluation of veterinary medicines. A list ofVICH guideline topics is provided in Table 7.1. 

Pharmaceutical products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice and Good Laboratory Practice. 

The individual scientist is the key to the production of quality data and must have technical competence and a dedication to quality work. Passive following of good laboratory practices and good measurement practices is not enough. Involvement in their development is required if the quality assurance program is to be credible. Standard operations procedures (SOPs) do not minimize the need for technical competence. Analysts exhibit varying degrees of proficiency when... 

European Commission, Guideline Developed with the Standing Committee on Plant Health with Regard to the AppUcabdity of Good Laboratory Practice to Data Requirements According to Annexes II, Part A and III, Part A of Council Directive 91/414/EEC, 7109/VI/94 Rev. 6, 14.07.1995. European Commission, Bmssels (1995). 

Because of the success of the CGMP laws, a new line of thought was developed that involved the subject of good laboratory practices. On December 22, 1978, the regulations entitled Non-clinical Laboratory Studies were issued in the Federal Register [21]. These regulations, which became known as Good Laboratory Practice, are involved in the evaluation of nonclinical laboratory studies. 

Test facilities in the OECD (Organization for Economic Co-operation and Development) member countries that conduct regulatory studies must comply with the OECD Principles of Good Laboratory Practice (GLP), as set out in Council Decision C(97)186/Final. These are referred to as GLP Principles. GLP came into prominence in the late 1970s in response to some malpractice in research and development activities of pharmaceutical companies and contract... 

Note that good laboratory practice (glp) should not be confused with Good Laboratory Practice (GLP). The latter is the name given to a set of principles governing the organizational process and the condition under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported, and was put forward initially by the Organization for Economic Co-operation and Development (OECD) (see Chapters 2 and 9). 

To date, the Part II Programme has focused upon four major projects (1) The development and implementation of a set of Principles of Good Laboratory Practice (GLP s) (2) Resolution of issues concerning Confidentiality of Data (3) Development of a Glossary of Key Terms and (4) Development of guidelines and other procedures for the exchange of information (e.g., re test data, the export of hazardous chemicals, and the labelling of hazardous chemicals). 

For TM to be accepted into mainstream medical treatment, a likely scenario is the application of scientific methodologies and controls for TM development, evaluation, and production. Many of the tools for high throughput screening (HTS) and assay systems can be used to test the efficacy of TM, similar to the irrational approach of screening natural products. Pharmacology studies have to be conducted in accordance with Good Laboratory Practice (GLP). 

Bajpai, M. Esmay, J. D. In vitro studies in drug discovery and development an analysis of study objectives and application of good laboratory practices (GLP). Drug Metab Rev 2002, 34, 679-689. 

As a tool to make mutual acceptance of risk assessments possible, OECD has developed the concept of Good Laboratory Practice (GLP). The OECD Principles of GLP are an integral part of the 1981 OECD council decision on the Mutual Assessment of Data (MAD) in the Assessment of Chemicals (revised 1997, Section 2.2.2). MAD also harmonizes procedures of GLP compliance monitoring, ensuring that preclinical safety studies are carried out according to the principles of GLP and that countries can have conftdence in the quahty and rigor of safety tests. 

Compliance with the GLP principles covers many aspects of accreditation to ISO 17025. The European Union has adopted the procedures for Good Laboratory Practice of the Organization for the Economic Cooperation and Development (OECD) and calls on member states to take all measures necessary to ensure that laboratories carrying out tests on chemical products comply with the GLP principles. The OECD s GLP principles are part of the Eiuopean Commission Directive 2004/10/EC (http //eur-lex. europa.eu). 

OECD Member States developed the OECD principles of GLP, utilising common managerial and scientific practices and experience from varions national and international sources. The purpose of these principles of good laboratory practice is to promote the development of quality test data. 

Good Laboratory Practice is a quality system that is tailored to the needs of the modem laboratories. Its principles are very close to the principles of the modem quality management systems like ISO 9000 and ISO 17025. However, GLP is specific to the non-clinical health and environmental safety studies, it covers physical and chemical test systems, and gives emphasis to biological test systems. It is of utmost importance to note that GLP principles were set out by the Organization for Economic Cooperation and Development (OECD) and after being modified they were adopted by the Emopean Union and are now the Commission Directive 1999/11/EC. 

Two American Chemical Society short courses were instrumental in the development of this manuscript. These were (1) "Quality Assurance in the Analytical Testing Laboratory/ taught by Gillis and Callio, and (2) "Good Laboratory Practices and ISO 9000 Standards Quality Standards for Chemical Laboratories," taught by Mathre and Schneider. 

Finally, radiopharmaceuticals are often prepared on a daily basis within the framework of clinical studies which often last several months or years. They demand a viable and reproducible production chain, leading to a sterile- and pyrogen-free radiopharmaceutical of high radiochemical purity. Therefore, microprocessor-controlled automated synthesis devices [31] are developed in order to ensure routine pharmaceutical production. They are becoming mandatory in order to meet the demands related to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). 

---