GLP guidelines

Consideration was also given to the publication of GLP guidelines rather than regulations. While this would have provided the testing facilities with standards of conduct, it would not have given the agency an enforcement mechanism to ensure that the standards were met. 

All the discovery stage quantitative and qualitative LC-MS assays (levels I, II, and III), which are used to select dmg candidates for development, are not rigorously validated and are not required to satisfy any of the good laboratory practices (GLPs) guidelines set forth by the regulatory agencies (Shah et al., 2000 Hsieh and Korfmacher, 2006 Jemal and Xia, 2006). 

The third area is sanple retention. The industry is having seme difficulty with this, particularly with respect to the retention of crop and tissue sanples which have been analyzed for residues. A "forever" retention criteria creates enormous practical problems. We would hope that the regulations will provide sane flexibility in this area. A fixed time limit seems reasonable. The NACA GLP guideline document dealt with sanple retention as follows ... 

Standard operating procedures (SOPs) are required for all routine activities that are critical to the successful outcome of the study including quality assurance procedures and inspections. Most of the SOPs for the field activities are written by the field scientists with guidance from the Quality Assurance Section. For the field activities, it is required that at each site there be SOPs for such things as how field plots are established and the plot boundaries marked, the maintenance of sample freezers, how to calibrate and maintain chemical balances and chemical application equipment, and how to obtain test chemicals. If an SOP for a critical item of equipment is not available, the study would be considered to be not in compliance with the principles of the GLP guidelines. The distribution of SOPs is carefully controlled so that when an SOP is changed, all outdated copies can be exchanged for the new version. 

Good science exists in research in academic institutions apart from the soon to be established Environmental Protection Agency s (EPA) Good Laboratory Practice (GLP) guidelines. However, this is not to say that GLP s are not advisable. Good science should be able to stand up to review as having been performed using appropriate and adequate laboratory practices. Scientists have had their work routinely scrutinized by their peers for its quality and will not resent careful analysis by others. For example, only a portion of the work produced by the scientific community is acceptable for publication in its various journals. The rate of acceptance in journals varies but it is apparent that the peer review system attempts to serve as a quality control mechanism in the scientific community. 

There are several areas in the GLP guidelines which are more difficult to implement in an academic setting than in other settings. These are requirements for a separate Quality Assurance Unit (QAU) and the responsibilities thereof establishing Standard Operating Procedures (SOP s) and conformance to them as written and the significant added costs of doing business under the GLP s. 

For ISO 9000 approval there are several certification bodies who register and certify companies meeting the requirements. In the UK such certification bodies must themselves be accredited by UKAS as competent to carry out certifications. For GLP. the GLP Monitoring Authority of the Medicines Control Agency issues a letter of compliance to an approved laboratory. This is restricted to laboratories carrying out safety studies as described above. However, any laboratory may state they work within the GLP guidelines. In the case of accreditation by UKAS, a Certificate of Accreditation is issued which relates to specific tests or calibrations. Laboratories will be included in UKAS s list of accredited laboratories, i.c. UKAS Directory of Accredited Labora-... 

Gstraunthaler G. Standardisation in Cell and Tissue Culture -The Need for Specific GLP Guidelines in the Cell Culture Laboratory (Good Cell Culture Practice - GCCP). ALTEX 23 SuppI 274-277,2006. 

Good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) guidelines of the EU were issued uid the drug approval application format Wcis harmonized with the EU Notice for Applicants. 

Although most GLP guidelines apply formally only to nonclinical safety studies, general principles of GLP should also be followed in the analysis of biological samples from clinical trials. 

Even if the laboratory does not work under GLP guidelines it is recommendable to check the whole HPLC system with a validated standard operating procedure (SOP) in regular time intervals. The results should be documented. The guideline can be found in Chapter 25. 

GLP guidelines have been set up for toxicological investigations of newly developed chemicals or pharmaceuticals. Gradually, more and more scientific areas and types of industries have been involved in GLP, especially for safety aspects of new products. General testing laboratories are usually not concerned and the GLP rules are mostly not applied to their work. For such laboratories or for other type of industries, the... 

The notebook should attempt to follow similar processes such as described in the FDA GLP guidelines. 

Thin-layer chromatography (TLC) is a very old method of analysis that has been well proven in practice. For more than thirty years, it has occupied a prominent position, especially in qualitative investigations. With the development of modern precoated layers and the introduction of partially or completely automated equipment for the various stages of operation of TLC, not only are highly accurate quantitative determinations now possible, but also the requirement that the work should comply with the GMP/GLP guidelines can be fulfilled. 

If TLC is used as an analytical method in quality control, the reproducibUity, i.e. lack of scatter (precision of both system and method), and also the accuracy of the analytical results must be determined. The GMP/GLP guidelines also require vahdation of the method, i.e. testing for linearity, selectivity, robustness and limits of detection and determination (see also Section 9.1 Validation of TLC Methods ). For method development, high demands are placed on the stationary phases of the chromatographic system ... 

To have a clear picture of the storage of TLC precoated layers for routine and developmental work, and to comply with the GMP/GLP guidelines, the following method of working has been found to be satisfactory ... 

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