TRAINEE - World Health Organization

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Chapter 1 • GLP Training Manual <strong>TRAINEE</strong>S the study. Since being able to repeat studies and obtain similar results is a sine qua non of mutual acceptance of data (and, indeed, a central tenet in the scientific method), the routine procedures are described in written standard operating procedures (SOPs). Laboratories may also need to standardize certain techniques to facilitate comparison of results; here again written SOPs are an invaluable tool. 3. Characterization In order to perform a study correctly, it is essential to know as much as possible about the materials used during the study. For studies to evaluate the properties of pharmaceutical compounds during the pre-clinical phase, it is a pre-requisite to have details about the test item and about the test system (often an animal or plant) to which it is administered. 4. Documentation Raw Data All studies generate raw data. These are the fruits of research and represent the basis for establishing results and arriving at conclusions. The raw data must also reflect the procedures and conditions of the study. Final Report The study report, just like all other aspects of the study, is the responsibility of the study director. He/she must ensure that the contents of the report describe the study accurately. The study director is also responsible for the scientific interpretation of the results Archives Storage of records must ensure safekeeping for many years, coupled with logical and prompt retrieval. 5. Quality Assurance Quality assurance (QA) as defined by GLP is a team of persons charged with assuring management that GLP compliance has been attained within the laboratory. They are organized independently of the operational and study programme, and function as witnesses to the whole pre-clinical research process. 5
6 <strong>TRAINEE</strong>S Chapter 1 • GLP Training Manual THE OECD GLP PRINCIPLES GLP started when the FDA issued mandatory requirements on June 20 1979. Subsequently the FDA has revised these regulations a number of times but has never changed the basics. At no time has the FDA changed the scope of the regulations; they still apply to non-clinical studies used to evaluate safety. Preliminary pharmacological studies and pharmacokinetic studies not designed to test safety are still exempt from GLP requirements. A little later, the OECD brought out Principles for GLP concerning the testing of any chemical substances. This GLP text is binding on all OECD member states and, as a consequence, has dominated GLP worldwide. This is why these GLP Principles have been used as the basic rules for the training programme devised for the WHO. The OECD recognizes that not all parts of the GLP Principles are easy to interpret. This is why the OECD has instituted a series of advisory documents on various aspects of GLP organization. There are seven consensus type documents. They have mostly been derived through discussion between the regulators and industry during consensus workshops. The contents of the consensus documents represent the current thinking of the OECD on the domain covered by the document. Any member state can request that a particular subject be discussed during a consensus meeting, it is up to the organization of the OECD to decide whether or not the subject is of general interest and merits a full three-day consensus type meeting. The OECD has a GLP Group made up of senior members of the respective member states’ GLP monitoring authorities. This group oversees the GLP activities of the OECD. These activities include the organization of training courses for GLP inspectors from all over the world and the organization of joint inspections, which are performed with a view to harmonizing the approach of various member states to GLP inspections.
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