Good laboratory practice application

Cooper-Hannan, R, Harbell, JW, Coecke, S, Balls, M, Bowe, G, Cervinka, M, Clothier, R, Hermann, F, Klahm, LK, de Lange, J, Liebsch, M, and Vanparys, Ph (1999), The Principles of Good Laboratory Practice Application to In Vitro Toxicology Studies, ATLA 27, pp.539 - 577. 

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on 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... 

Analytical chemistry is a critical component of worker safety, re-entry, and other related studies intended to assess the risk to humans during and subsequent to pesticide applications. The analytical aspect takes on added significance when such studies are intended for submission to the U.S. Environmental Protection Agency and/or other regulatory authorities and are thus required to be conducted according to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Good Laboratory Practice (GLP) Standards, or their equivalent. This presentation will address test, control, and reference substance characterization, use-dilution (tank mix) verification, and specimen (exposure matrix sample) analyses from the perspective of GLP Standards requirements. 

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. 

Note GLP = Good Laboratory Practice ICH = International Conference on Harmonization IND = Investigational New Drug JMHW = Japanese Ministry of Health and Welfare MAA = Marketing Authorization Application NCE = New Chemical Entity. 

Successful applications of the SPMD technology under a wide variety of field conditions have been demonstrated by a number of researchers (see Appendix B or CERC, 2004). The common threads among successful applications of SPMDs are a basic understanding of potential sources of sample contamination and losses, the functional aspects of the SPMD technique, and the adherence to sound sampling approaches and good laboratory practices. 

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. 

Applications for marketing should be sent to MHLW. The application then passes to PMDA, where the application splits into two different routes, namely (1) good laboratory practice (GLP), GCP and reliability compliance check by Office of Conformity Audit and (2) application review by Offices of New Drug or Office of Biologies. 

The recent amendment in November 2008 to the drugs and cosmetic rules (II) includes a new Schedule L-1, which covers the Good Laboratory Practices and Requirements of Premises and Equipments, primarily for laboratories that support manufacture. Despite such specific emphasis of its applicability, the details of GLP requirements are in general alignment with those of the OECD, USFDA, USEPA, etc. 

To coordinate the application of good laboratory practices within the NRLs (63, 64). 

Figure 2.7. Studies requiring bioanalytical quantitation during drug discovery and development. (GLP, Good laboratory practices IND, Investigational new drug application.)...

Garner WY, Barge MS, Ussary I.P (eds) (1992) Good laboratory practice standards. Applications for field and laboratory studies. ACS, Washington DC... 

Most applications require that certifications be included with the submission, either in the administrative section of the application or within reports of specific types of data included in the application. These include field copy certifications, debarment certifications, current good manufacturing practice (cGMP) certifications, current good laboratory practice... 

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