Critically Analyse The Role Of Good Laboratory Practice (GLP)

CRITICALLY ANALYSE THE ROLE OF GOOD LABORATORY PRACTICE (GLP)

Contents

Introduction. 3

Scope of Good Laboratory Practice. 3

Purpose of Good Laboratory Practice. 4

Regulation Governing Good Laboratory Practice. 4

Benefits and Drawbacks of Good Laboratory Practice. 5

Conclusion. 5

References. 7

Introduction

Good laboratory practice refers to a group of principles that have been formulated for assuring both quality as well as integrity of non-clinical laboratory studies (Haeckel, 1999) undertaken with the intention of supporting either marketing permits or research for products that are under the regulation of governmental agencies (Seiler, 2001). In fact, GLP is a term that is usually used in association with the pharmaceutical industry. Interestingly, GLP is mandatory for all animal-related testing done outside of clinical research that must necessarily be successfully performed before receiving approval for any new drug.

Scope of Good Laboratory Practice

Unlike the GCP (Good Clinical Practices) which is stipulated for Clinical studies; the structure of GLP is dependent o the responsibilities of the Study Director and his role in the studies being undertaken. The study Director is tasked with the responsibilities for both the execution and the oversight associated with the non-clinical study. Based on this definition, it would be apt to state that GLP does not define scientific standards. Rather, it can be described as a set of quality standards for conducting the non-clinical study, data collection and reporting of the results of the study. The GLP is monitored by the Study director, who is responsible for ensuring that the studies are competent enough to fulfill the expectations from them. For example, the Study Director would verify the non-clinical animal testing, its analysis and the reports being submitted by the members who are part of the study, before finalization. Furthermore, he would take regular meetings to determine the progress of the study as well as ensure that the members receive periodic training and reviews so that the studies are appropriate, accurate and within the scope of the research topic rather than going off on a tangent (Todd et al., 2014).

Purpose of Good Laboratory Practice

The primary purpose of GLP is ensure that all non-clinical studies adhere to a set of standards and meets the quality requirements that are decided by the regulating agencies. This is achieved by the Quality Assurance (QA) Unit, a key element in the GLP system. The QA is a monitoring body made up of one or more individuals who ensure that the studies follow the written procedures accurately (Hailey, 2013).  For instance, if the guidelines state that the results of the non-clinical study must be verified by a microbiologist and a senior pharmacologist, then the quality Auditor ensures that this procedure is followed by verification of digital signatures, reviewing of signed document, by email confirmation, direct meeting or even a telephonic confirmation from the concerned person. Furthermore, the seniority and qualification is determined on the basis of certificates as well as periodic training
(Schmidt, 2012).

Regulation Governing Good Laboratory Practice

Important regulations governing GLP would vary from country to country as well as between different geographical divisions within the country. The European Union Law governs GLP across Europe; while the Federal agency is tasked with the governance of GLP In the United States (Seiler, 2001). However, some of the commonly occurring regulations that are seen across countries include:

• GLP work requires a minimum of 2-3 members in the team. This includes a QA reviewer, an analyst and a manager. For projects with clearly defined Standard Operating Procedures (SOP) the analyst and the manager may be the same person thus bringing down the team size to 2.
• The results of GLP are not correct or incorrect. They merely certify that the study is in accordance with the quality system. The results are concerned with the proper conduct of the research rather than the results themselves (Ezzelle et al., 2008).
• GLP must be limited to on-clinical studies and therefore, are not to be used for bio-analysis as part of human clinical studies (Roy, 2011).

Benefits and Drawbacks of Good Laboratory Practice

GLP is necessary for building the reputation of any professional laboratory. It helps in generating goodwill among clients, employees, regulators and competitors and can be deemed as the primary benefit of a GLP (Turnheim, 1993).  However, since GLPs are only concerned with the quality of the methodology adhering to predefined and determined standards (Ezzelle et al., 2008), GLPs are not the best measurement of the accuracy of the research or the result. They are only concerned that the studies follow the SOP defined at the commencement of the studies. This is a drawback when looking at the findings of the non-clinical studies.

Conclusion

GLP are instrumental in determining the feasibility and advantages offered by any laboratory for the purposes of non-clinical studies (Ezzelle et al., 2008) including animal studies and are closely linked with although not limited to the pharmaceutical industry. GLP is a necessity for ensuring that the non-clinical studies are valid as it ensures the adherence to quality standards with regard to the operating procedures to be followed as part of the study and hence considered an important part of research.

References

Ezzelle, J., Rodriguez-Chavez, I., Darden, J., Stirewalt, M., Kunwar, N., Hitchcock, R., Walter, T. and D’Souza, M. (2008). Guidelines on good clinical laboratory practice: Bridging operations between research and clinical research laboratories. Journal of Pharmaceutical and Biomedical Analysis, 46(1), pp.18-29.

Haeckel, R. (1999). The Meaning of Good Laboratory Practice (GLP) for the Medical Laboratory. Clinical Chemistry and Laboratory Medicine, 37(2).

Hailey, J. (2013). The Role of the Peer Review Pathologist in Good Laboratory Practices Studies: A Sponsor Perspective. Toxicologic Pathology, 42(1), pp.278-282.

Roy, C. (2011). Good Clinical Laboratory Practice (GCLP): Quality Demanding from Clinical Laboratories. Bangladesh Journal of Medical Microbiology, 4(1).

Schmidt, C. (2012). Judging the Data: Peer Review versus Good Laboratory Practice Standards. Environmental Health Perspectives, 120(7), pp.a285-a285.

Seiler, J. (2001). Good laboratory practice. Berlin: Springer.

Todd, C., Sanchez, A., Garcia, A., Denny, T. and Sarzotti-Kelsoe, M. (2014). Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL). Journal of Immunological Methods, 409, pp.91-98.