Basic GLP

The good news is that harmonization efforts are under way, and basic GLP principles are similar. Nevertheless, differences do exist. Major differences include the requirements for the specific contents of protocols and final reports and the retention times for records, samples, and specimens. Manufacturers must become familiar with the GLPs that concern their products, learn to which worldwide regulatory agencies their data will be submitted, and know which legislation covers the material being produced and evaluated. 

Method validation, on the other hand, is normally considered part of the study in which the method will subsequently be used or consists of a separate defined study unto itself as such, it is normally required to be accomplished under GLP purview. There is, however, some confusion in some circles as to exactly what is meant by analytical method validation. Some chemists describe it as adaptation of one method from one type of matrix for use with another using basically the same or similar analytical approach. Others take a more strict interpretation and define validation as simply demonstration of the ability to achieve satisfactory results using a published procedure in one s own laboratory setting. Often, validation incorporates both interpretations. 

Adherence to basic principles of GLP to ensure quality of the study including a detailed protocol prepared prospectively. 

Good Laboratory Practice is a qnahty system concerned with the organisation of the test facility and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. This is the GLP Decalogue stating the basic principles that the laboratory must follow. 

Many of the issues relating to the definition of nonchni-cal laboratory study were addressed in the discussion of GLP 58.1 (Scope). Field trials in animals includes all efficacy studies of new animal drugs. Such studies are outside the scope of the GLP regulations. This is consistent with the GLP exemption for human clinical trials. The exemption for basic exploratory studies carried out to determine whether a test article has any potential utility would extend to early screening studies of a test article, the results of which are used to determine whether a test article merits further development or not. 

It should be noted that the basic elements of the DCLS QA Program closely parallel those set forth in the GLP regulations. Each of the major components of the GLPs is addressed in the BOC QA Plan. 

Integration of Quality Assurance concepts into the laboratory is the key to GLP compliance and is usually accomplished in three phrases under the guidance of the QAU. In the Management Phase the basic plan is formulated based on policies decided upon by management. In the second phase the QAU prepares the laboratory for the final implementation phase. General rules for integration are given as are levels of acceptance that may be expected from laboratory personnel. 

The format of a study protocol 1s left to the entity developing the protocol however, the basic requirements are clearly set forth 1n the GLP regulations. The forthcoming broad application of GI.Ps to chemistry-based and field studies means that, for the first time, many groups will find the need to develop study protocols that will conform to the requirements of GLPs. 

The conduct of a chemistry-related good laboratory practice (GLP) laboratory inspection and data audit will be discussed in this paper. This will be accomplished fcy describing the basic audit procedure, then digressing into the objectives of an audit and the primary problem areas that have been experienced. 

Traceability and uncertainty of measurement results are basic technical elements of quality systems in analytical laboratories whose competence is recognized by accreditation according to ISO/IEC 17025 [24]. However, GLP and GMP standards widely used since the 1960s for the... 

Proper basic knowledge in science in association with GLP data-collection standards helps to achieve research integrity and success. It is expected that all workers, organizations, and industries adhere to GLP standards for study documentation, sample handling, data management, and reporting. Only the use of GLP and manpower together can enrich chemical safety for the improvement of human health and safety worldwide. 

Understanding quality and gaining skills in efficiently producing chemicals of standard quality—they also learn the basics of GLP and GMP... 

Clinical studies may be supported by computer systems in a number of ways from data capture, data processing, production control, and document management. Some systems may be complex, others simple. Some systems may be custom-made, others based on COTS products. Whatever the character of a clinical computer system, the same basic GCP/GLP principles apply. All computer systems that play a part in the conduct or support of clinical studies intended for regulatory... 

Process audits, on the other hand, have specifically been addressed in the revised 1997 GLPs, and these are basically aimed at auditing short-term studies of a repetitive nature, generally undertaken by similar teams of people. Here, that the system is working and that parts of the process are reviewed over a quoted period in the QA SOP are assured. The aim is to ensure that all critical aspects of this process are reviewed through different studies over a period of time. This, then, does not necessitate QA review of all short-term studies on every occasion, nor does it require the review of such areas as analytical analysis on a batch-by-batch basis or the analysis of hematology or biochemistry samples each time these come up for analysis. 

The entire aspect of archiving is basically one of common sense, and guidance on how to archive these materials can be obtained from government agencies that store personnel records or from libraries. [Additional information on archiving is available in GLPs under Section II, 3.4, p. 22 and 10, p. 29 and in the British Standard for Archiving. 

GLP studies and basic research being done in the same laboratory without a clear division of research. 

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