GLP systems

Plant metabolism studies will provide information on the absorption, translocation, dissipation and degradation of the agrochemical. This information defines the residual analytes of regulatory concern that could include either the parent compound or metabolites in the field crops. Plant metabolism studies should be conducted with at least three crop representatives of three different crop groups listed in Table 1. One of the major objectives is to determine the comparative metabolism of the agrochemicals between animals and plants among different plant species. MAFF approves metabolism studies that are conducted in foreign countries, which should be operated under the certified GLP system. 

If the decision is to implement the GLP system across the organization the cost and time commitment is signifi-... 

In talking to many people who have operated under the GLP system for the past 20 years, it is generally heard that the system allows for a better standard of... 

It might be added here, that it is also management who has to ensure that an individual is identified as responsible for the archive. This is an organisational matter and as such lies without any question in the realm of management the respective paragraph just serves to remind management that one of the major elements of GLP is the archiving of aU pertinent documentation and other study-related items, which are necessary for the fiiU reconstructability of any study, and that therefore the person responsible for the archives holds another pivotal position in the GLP system. 

The workload caused by the formalism and archiving is much larger compared than that attributable to the EN 45000 directives. The GLP system is apphed in areas covered by legislation, for example, in the case of the introduction of new chemicals, in toxicology, or in health systems. 

Due to their wide range of analytical challenges centralized analytical laboratories are required to adopt a series of QM systems simultaneously. For example, the Competence Center Analytics of BASF AG in Ludwigshafen is certified and accredited to operate under four different QM systems. Undoubtedly, QM systems play a vital role in a modern industrial analytical laboratory. The sale of many products of the chemical industry is not possible without a GLP-certified analytical laboratory. However, in practical tenus the different QM systems can potentially reduce the efficiency of the analytical process and lead to increased costs. 

In conclusion, the discovery of incretins has now come to an end in terms of therapeutic strategy of metabolic diseases since new medicines will be put on the market these coming years. However, a lot more needs to be done with regard to the physiological role of the hormones. Whereas the major filed of investigation for GLP-1 now relates to the effect of the peptide on the central nervous system and on (3-cell proliferation, for GIP it remains to understand its role in the numerous tissues where the corresponding receptor is expressed. 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

Laboratory notebooks—It may be debatable to consider laboratory notebooks as text documents, but they should be mentioned here because of their importance in preclinical development. Laboratory notebooks are used to record experimental procedures, observations, raw data, and other important information. Although laboratory notebooks are rarely used for submission to regulatory agencies directly, they are available for inspection by the authorities in the Preapproval Inspection (PAI) and other GMP/GLP-related inspections. Currently, most of the major pharmaceutical companies still use paper-based laboratory notebooks. Electronic-based notebook systems are being developed and commercialized, which are discussed in Chapter 9. 

An additional requirement not noted in Table 1 is compliance with GLP7 These practices establish a paper trail for all procedures involved in the determination of residues. With regard to immunoassays, GLPs require calibration of measurement devices such as adjustable pipettors and dedicated spectrophotometers. Computer software output, as noted above, must be verified prior to use. This process can be simplified by limiting the application of specialized software to the operation of an instrument and carrying out the residue calculations in a broadly available spreadsheet such as Excel. On a positive note, in recent years, the software accompanying most microtiter plate readers has become generally easier to use and usually incorporates internal spreadsheets that are compatible with external systems. 

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