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CBMS861 Laboratory Quality Systems
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CBMS861 Laboratory Quality Systems
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Course Code: CBMS861
University: Macquarie University
MyAssignmentHelp.com is not sponsored or endorsed by this college or university
Country: Australia
Question:
Compare the requirements for testing and personnel of ISO 17025 with the similar OECD Principles of Good Laboratory Practice. Discuss the similarities and differences between the two standards and evaluate whether one standard is better than the other in dealing with these areas of a laboratory operation. Use examples to justify your answer.
Answer:
Introduction:
The Organization for Economic Co-operation and Development (OECD) principles for good laboratory practices were implemented by organizations and the government with an aim of promoting the quality of information in tests (Kauffmann et al, 2017). ISO 17025 on the other hand, is the international standards set to ensure laboratories have quality management systems which are technically competent in the performance of duties (AbdelWareth et al, 2018). This paper discusses the similarities and differences between the two standards and whether one is better than the other in dealing with areas of laboratory operation.
OECD principles for GLP were implemented by organizations and the government with an aim of promoting the quality of information in tests. This was done by improving the quality of health in non-clinical and the safety environmental standards when it comes to the basis of hazard assessment like chemicals and their products (Kauffmann et al, 2017). ISO 17025 on the other hand, is the international standards set by the community and testing laboratories like non-clinical to ensure laboratories have quality management systems which are technically competent in the performance of duties (AbdelWareth et al, 2018).
When it comes to the application of principles, the OECD principles for GLP are specific and clearly defined on quality assurance and the responsibilities of the shareholders. The major difference between the two are the types of projects carried out by laboratories. An example of the long-term projects is carrying out toxicological tests in laboratory animals (Amiard & Amiard-Triquet, 2015). It takes so many months and involves various scientific fields. Additionally, the field and greenhouses may be used to conduct tests.
Those of ISO 17025 are short-term and apply different methods of analysis on the samples when they are delivered by the customer. Similarly, ISO 17025 can carry out chemical tests but they have to comply with the OECD principles for GLP. Additionally, ISO 17025 has requirements that do not apply principle like focusing the requirements of customers, improvement of quality and technical concepts.
In my opinion, the OECD principles for GLP are better than those of ISO 17025 in dealing with the areas of laboratory operations. First, the OECD principles for GLP are specific and clearly defined when it comes to activities of quality assurance and the responsibilities of the shareholders. Inspectors are hired to ensure regulations are adhered to and audit studies of individuals.
Second, OECD principles for GLP apply various fields of study. The OECD principles of GLP are long-term. An example of the long-term projects is carrying out toxicological tests in laboratory animals (Amiard & Amiard-Triquet, 2015). It takes so many months and involves various scientific fields like analytical, chemical and microbiological tests.
Finally, OECD principles for GLP applies its standards and those of ISO 17025. Mianes & ten Caten (2017), noted that the requirement at this stage is that, at the completion of the tests, the results would be confirmed by the “National GLP Compliance Monitoring Authority.” Confirmation of tests avoid problems like the variability inherent, scientific nature of multi-disciplinary, nature of multi-site and the distinction in chemical products.
References
AbdelWareth, L. O., Pallinalakam, F., Ibrahim, F., Anderson, P., Liaqat, M., Palmer, B., … & Alduaij, A. (2018). Fast track to accreditation: an implementation review of College of American Pathologists and International Organization for Standardization 15189 accreditation. Archives of pathology & laboratory medicine, 142(9), 1047-1053.
Amiard, J. C., & Amiard-Triquet, C. (2015). Conventional risk assessment of environmental contaminants. In Aquatic Ecotoxicology (pp. 25-49).
Kauffmann, H. M., Kamp, H., Fuchs, R., Chorley, B. N., Deferme, L., Ebbels, T., … & Tollefsen, K. E. (2017). Framework for the quality assurance of’omics technologies considering GLP requirements. Regulatory Toxicology and Pharmacology, 91, S27-S35.
Mianes, R. L., & ten Caten, C. S. (2017). Organisation of proficiency schemes by testing and calibration laboratories. Accreditation and Quality Assurance, 22(3), 119-123.
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