Good Laboratory Practice GLP

Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. Adherence by test facilities to the principles of GLP ensures that there is a proper plan ning of studies and the availability of adequate means to carry out such studies. It facilitates the proper conduct of studies, promotes their full and accurate reporting, and a process whereby the validity and integrity of the studies can be verified. The application of GLP to regulatory studies assures the quality of the data generated and allows its use by Government regulatory authorities in hazard and risk assessment in particular of new substances. A very useful pocket-book guide to GLP and the UK GLP Regulations has been produced by the Department of Health, and should be consulted by students seeking further information [B-26].

The OECD has produced an internationally accepted set of "Principles of Good Laboratory Practice" in order to promote the development of quality test data. These have been ratified by the European Commission and transposed into EC Directives.

Comparable quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently rely on test data developed in other countries, duplicative testing can be avoided, thereby saving time and resources. The application of these Principles helps to avoid the creation of technical barriers to trade, and further improve the protection of human health and the environment.

The Manager of a testing laboratory is responsible for ensuring that the Principles of Good Laboratory Practice are complied with in the facility. The OECD has set down the minimum responsibilities, which should be to

• Ensure that a statement exists which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by these Principles of Good Laboratory Practice.

• Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study.

• Ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual.

• Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions.

• Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures.

• Ensure that there is a Quality Assurance Programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice.

• Ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the Study Director, before the study is initiated. Replacement of a Study Director should be done according to established procedures, and should be documented

• Ensure, in the event of a multi-site study, that, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator should be done according to established procedures, and should be documented.

• Ensure documented approval of the study plan by the Study Director.

• Ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel.

• Ensure the maintenance of an historical file of all Standard Operating Procedures.

• Ensure that an individual is identified as responsible for the management of the archive(s).

• Ensure the maintenance of a master schedule.

• Ensure that test facility supplies meet requirements appropriate to their use in a study.

• Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel.

• Ensure that test and reference items are appropriately characterised.

• Establish procedures to ensure that computerised systems are suitable for their intended purpose, and are validated, operated and maintained in accordance with these Principles of Good Laboratory Practice.

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Project Management Made Easy

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