Good Laboratory Practice

Öz

Good laboratory practice (GLP) is concerned with the organisational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. Adherence by test facilities to the principles of GLP ensures the proper planning of studies and the provision of adequate means to carry them out. The purpose of this review is to facilitate the proper application and interpretation of the GLP principles for the organisation and management of studies.

Anahtar Kelimeler

• Good laboratory practice, quality assurance, laboratory management

İyi Laboratuvar Uygulamaları

Öz

İyi Laboratuar Uygulamaları (İLU) laboratuarların planladığı, uyguladığı, izlediği, kayıt altına aldığı ve raporladığı çalışmalarla ve bu organizasyonların işleyişleri ile ilginenmektedir. İLU prensipleriyle test alanlarındaki çalışmaların uygun olarak planlanması ve yeterli araçlarla yerine getirilmesi gerçekleştirilmektedir. Bu makalenin amacı, çalışmalar ve yönetimin organizasyonu için İLU prensiplerinin ve uygulamalarının açıklanarak kolaylaştırılmasıdır.

Anahtar Kelimeler

• İyi laboratuar uygulamaları, kalite güvence, laboratuar yönetim

Kaynakça

1. Boyacıoğlu, D. (2007). http://atlas.cc.itu.edu.tr/~boyaci/Iyi_Laboratuar_ Uygulamalari.pdf
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5. EPA (2007). Good Laboratory Practices (GLPs) for Pesticide Product Research (8/17/89)
6. Federal Regulations(1998). Good Laboratory Practice Standards. Part 792 (7-1-92 Edition) Chapter I, Section 792.1 through 792.195. Authority: 15 USC 2603, Source: 54 FR 34043.
7. Garfield, F and Klesta , E. (2000). Qualitiy Assuarance Principles for Analytical Laboratories. AOAC International, USA.
8. OECD. (1980). OECD Principles of Good Laboratory Practice Directive 87/18/EEC, Directive 88/320/EEC.

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16. OECD. (1999-d). Environment Directorate Joint Meeting of the Chemicals Committee and the Working Party on Chemicals. OECD Series on Principles of GLP and Compliance Monitoring Number 6. The Application of The GLP Principles to Field Studies. ENV/JM/MONO(99)22.
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18. OECD. (2004). OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 14 (Advisory Document of the Working Group on Good Laboratory Practice, The Application of the Principles of GLP to in Vitro Studies), Organisation for Economic Co-operation and Development, ENV/JM/MONO(2004)26.
19. Official Journal of the European Union. (2004). Directive 2004/10/Ec of The European Parliament and of The Council. On The Harmonisation of Laws, Regulations and Administrative Provisions Relating to the Application of the Principles Of Good Laboratory Practice and the Verification of Their Applications for Tests on Chemical Substances (codified version).
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23. UK Department of Health. (2000) The United Kingdom Good Laboratory Practice Monitoring Authority. Guide to UK GLP Regulations.
24. U.S. Department of Health and Human Sevices. (2000). Food and Drug Administration Office of Regulatory Affairs, Compliance Program Guidance for Industry Good Laboratory Practices.