Laboratory practices, good

GLP generally refers to a system of management controls for laboratories and research organizations to ensure the consistency and reliability of results as outlined in the Organisation for Economic Co-operation and Development (OECD) Principles of GLP and national regulations. Whereas the FDA and the U.S. Environmental Protection Agency (EPA) instituted GLP regulations, the OECD published GLP Principles in 1981, which now apply to the 30 member states of the OECD. 

The regulations set out the rules for good practice and help scientists to perform their work in compliance with internal standards and external regulations rather than evaluating scientific content or value of the research. GLP focuses on the following areas. 

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Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

Make a list of good laboratory practices for the lab accompanying this course (or another lab if this course does not have an associated laboratory). Explain the rationale for each item on your list. 

Standard reference materials provide a necessary but insufficient means for achieving accuracy and measurement compatibiUty on a national or international scale. Good test methods, good laboratory practices, well-qualified personnel, and proper intralaboratory and intedaboratory quaUty assurance procedures ate equally important. A systems approach to measurement compatibiUty is ikustrated in Figure 2. The function of each level is to transfer accuracy to the level below and to help provide traceabiUty to the level above. Thus traversing the hierarchy from bottom to top increases accuracy at the expense of measurement efficiency. 

The reviewer should estabHsh that the laboratory reporting the study has the necessary professional reputation, scientific experience, and expertise in the area investigated. It should be confirmed that adequate quaHty-control faciHties are in place and good laboratory practices and procedures foUowed. 

All testing to support notification must be performed by methods specified in Annex V to Directive 79/831/EEC and in accordance with the principles of good laboratory practice (GLP). GLP is concerned with the organizational processes and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. 

Laboratories wishing to claim GLP compliance are nonually registered with Competent Authorities who issue statements of compliance following successful periodic inspections of the premises to monitor compliance with the relevant legislation. In the UK compliance with the Good Laboratory Practice Regulations 1999 is audited by the Medicines Control Agency. 

SI 1999/3106 Health and Safety - The Good Laboratory Practice Regulations... 

There are a number of other regulations/directives that you will need to consult, as appropriate. These address topics such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), the conduct of clinical trials, variations to authorised drugs, and the use of genetically modified organisms. A list of the most relevant directives is shown in Table 1.5. 

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... 

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. 

COP7 New substances Principles of good laboratory practice Notification of New Substances... 

FDA resources are expended in areas based not on their absolute importance but on the lack of industry capability to control a particular concern. When manufacturing processes were primitive, unclean, and uncontrolled, the FDA issued the Good Manufacturing Practices and eventually the Good Laboratory Practices, Good Clinical Practices, and Good Tissue Practices. Together these Practices provide standards for the industry operations. 

The characterisation of the toxicity associated with a specific chemical is invariably dependent on feeding the chemical to laboratory animals in statistically-based lifetime bioassay, guidelines for which have been agreed at the international level by the OECD (OECD, 1981) and the IPCS (IPCS, 1999), and which are undertaken strictly in compliance with the principles of good laboratory practice (GLP). The animals used in long-term bioassays are... 

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... 

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