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Good Laboratory Practice

Year 2007, Volume: 27 Issue: 2, 43 - 56, 01.06.2007

Dilek Yalçın İlkay Açıkgöz

Abstract

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.

Keywords

Good laboratory practice quality assurance laboratory management

References

  • Boyacıoğlu, D. (2007). http://atlas.cc.itu.edu.tr/~boyaci/Iyi_Laboratuar_ Uygulamalari.pdf
  • Codex Alimentarius. (2003). Guidelines on Good Laboratory Practice in Pesticide Residue Analysis CAC/GL 40-1993, Rev. 1-2003 Volume 2A, Occupational Health & Safety Information Service's.
  • Çakmakcı, L. (2005, Mart). Tam Laboratuar Uygulamaları. Gıda Mikrobiyolojisi Uygulamalı Eğitim Kursu, Ankara Üniversitesi Gıda Mühendisliği & Gıda Teknolojisi Derneği, Ankara.
  • Deborah, K. (1999) Good Laboratory Practice Training Manual (For The Trainee). UNDP/Word Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), A Tool For Training and Promoting Good Laboratory Practice (GLP) Concepts in Disease Endemic Countries. Geneva.
  • EPA (2007). Good Laboratory Practices (GLPs) for Pesticide Product Research (8/17/89) <http://pmep.cce.cornell.edu/regulation/pcdregs-lib/gen.reg .glp.htlm>
  • 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.
  • Garfield, F and Klesta , E. (2000). Qualitiy Assuarance Principles for Analytical Laboratories. AOAC International, USA.
  • OECD. (1980). OECD Principles of Good Laboratory Practice Directive 87/18/EEC, Directive 88/320/EEC.
  • OECD. (1994). The Use Of Laboratory Accreditation With Reference To GLP Compliance Monitoring: Position of The OECD Panel on Good Laboratory Practice. As endorsed by the 22nd Joint Meeting of the Chemicals Group and Management Committee of the Special Programme on the Control of Chemicals.
  • OECD. (1995). Series On Principles Of Good Laboratory Practice And Compliance Monitoring Number 10 GLP Consensus Document. The Application of The Principles of GLP to Computerised Systems Environment Monograph No. 116.
  • OECD. (1998-a). Environment Directorate Chemicals Group And Management Committee OECD Series On Principles Of Good Laboratory Practice and Compliance Monitoring Number 11. Advisory Document of the Panel on Good Laboratory Practice. The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP 60994 ENV/MC/CHEM(98)16.
  • OECD. (1998-b). Environment Directorate Chemicals Group And Management Committee OECD Series on Principles of Good Laboratory Practıce And Compliance Monitoring Number 1. OECD Principles on Good Laboratory Practice ENV/MC/CHEM(98)17.
  • OECD. (1999-a). Environment Directorate Joint Meeting of the Chemicals Committe and the Working Party on Chemicals. ENV/JM/MONO(99)20, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 4 Consensus Document Quality Assurance and GLP.
  • OECD. (1999-b). Environment Directorate Joint Meeting of The Chemicals Committee and the working Party on Chemicals. OECD Series on Principles of GLP and Compliance Monitoring number 8 (Revised) Consensus Document. The Role and Responsibilities of the Study Director in GLP Studies. ENV/JM/MONO(99)24.
  • OECD. (1999-c). Environment Directorate Joint Meeting of The Chemicals Committee and the Working Party on Chemicals. OECD Series on Principles of GLP and Compliance Monitoring Number 7 (Revised) Consensus Document. The Application of the GLP Principles to Short Term Studies ENV/JM/MONO(99)23.
  • 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.
  • OECD. (2000). Environment Directorate Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. OECD Series on Principles of GLP and Compliance Monitoring Number 5. Compliance of Laboratory Suppliers with GLP Principles ENV/JM/MONO(99)21.
  • 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.
  • 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).
  • Scientific Institute of Public Health. (2006). Belgian GLP Compliance Monitoring Programme Manual, Bureau of Quality Assurance Brussels, Doc: 03/GLP Manual/E, Edition 2, Level 1, Annexes: 14.
  • Resmi Gazete. (2002). İyi Laboratuar Uygulamaları Prensipleri ve Test Laboratuarlarının Belgelendirilmesine Dair Yönetmelik, Resmi Gazete Tarihi: 25.06.2002, Resmi Gazete Sayısı: 24796.
  • Resmi Gazete. (2002). İyi Laboratuar Uygulamalarının Denetlenmesi ve Çalışmaların Kontrolüne Dair Yönetmelik, Resmi Gazete Tarihi: 25.06.2002, Resmi Gazete Sayısı: 24796.
  • UK Department of Health. (2000) The United Kingdom Good Laboratory Practice Monitoring Authority. Guide to UK GLP Regulations.
  • 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.

İyi Laboratuvar Uygulamaları

Year 2007, Volume: 27 Issue: 2, 43 - 56, 01.06.2007

Dilek Yalçın İlkay Açıkgöz

Abstract

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.

Keywords

İyi laboratuar uygulamaları kalite güvence laboratuar yönetim

References

  • Boyacıoğlu, D. (2007). http://atlas.cc.itu.edu.tr/~boyaci/Iyi_Laboratuar_ Uygulamalari.pdf
  • Codex Alimentarius. (2003). Guidelines on Good Laboratory Practice in Pesticide Residue Analysis CAC/GL 40-1993, Rev. 1-2003 Volume 2A, Occupational Health & Safety Information Service's.
  • Çakmakcı, L. (2005, Mart). Tam Laboratuar Uygulamaları. Gıda Mikrobiyolojisi Uygulamalı Eğitim Kursu, Ankara Üniversitesi Gıda Mühendisliği & Gıda Teknolojisi Derneği, Ankara.
  • Deborah, K. (1999) Good Laboratory Practice Training Manual (For The Trainee). UNDP/Word Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), A Tool For Training and Promoting Good Laboratory Practice (GLP) Concepts in Disease Endemic Countries. Geneva.
  • EPA (2007). Good Laboratory Practices (GLPs) for Pesticide Product Research (8/17/89) <http://pmep.cce.cornell.edu/regulation/pcdregs-lib/gen.reg .glp.htlm>
  • 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.
  • Garfield, F and Klesta , E. (2000). Qualitiy Assuarance Principles for Analytical Laboratories. AOAC International, USA.
  • OECD. (1980). OECD Principles of Good Laboratory Practice Directive 87/18/EEC, Directive 88/320/EEC.
  • OECD. (1994). The Use Of Laboratory Accreditation With Reference To GLP Compliance Monitoring: Position of The OECD Panel on Good Laboratory Practice. As endorsed by the 22nd Joint Meeting of the Chemicals Group and Management Committee of the Special Programme on the Control of Chemicals.
  • OECD. (1995). Series On Principles Of Good Laboratory Practice And Compliance Monitoring Number 10 GLP Consensus Document. The Application of The Principles of GLP to Computerised Systems Environment Monograph No. 116.
  • OECD. (1998-a). Environment Directorate Chemicals Group And Management Committee OECD Series On Principles Of Good Laboratory Practice and Compliance Monitoring Number 11. Advisory Document of the Panel on Good Laboratory Practice. The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP 60994 ENV/MC/CHEM(98)16.
  • OECD. (1998-b). Environment Directorate Chemicals Group And Management Committee OECD Series on Principles of Good Laboratory Practıce And Compliance Monitoring Number 1. OECD Principles on Good Laboratory Practice ENV/MC/CHEM(98)17.
  • OECD. (1999-a). Environment Directorate Joint Meeting of the Chemicals Committe and the Working Party on Chemicals. ENV/JM/MONO(99)20, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 4 Consensus Document Quality Assurance and GLP.
  • OECD. (1999-b). Environment Directorate Joint Meeting of The Chemicals Committee and the working Party on Chemicals. OECD Series on Principles of GLP and Compliance Monitoring number 8 (Revised) Consensus Document. The Role and Responsibilities of the Study Director in GLP Studies. ENV/JM/MONO(99)24.
  • OECD. (1999-c). Environment Directorate Joint Meeting of The Chemicals Committee and the Working Party on Chemicals. OECD Series on Principles of GLP and Compliance Monitoring Number 7 (Revised) Consensus Document. The Application of the GLP Principles to Short Term Studies ENV/JM/MONO(99)23.
  • 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.
  • OECD. (2000). Environment Directorate Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. OECD Series on Principles of GLP and Compliance Monitoring Number 5. Compliance of Laboratory Suppliers with GLP Principles ENV/JM/MONO(99)21.
  • 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.
  • 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).
  • Scientific Institute of Public Health. (2006). Belgian GLP Compliance Monitoring Programme Manual, Bureau of Quality Assurance Brussels, Doc: 03/GLP Manual/E, Edition 2, Level 1, Annexes: 14.
  • Resmi Gazete. (2002). İyi Laboratuar Uygulamaları Prensipleri ve Test Laboratuarlarının Belgelendirilmesine Dair Yönetmelik, Resmi Gazete Tarihi: 25.06.2002, Resmi Gazete Sayısı: 24796.
  • Resmi Gazete. (2002). İyi Laboratuar Uygulamalarının Denetlenmesi ve Çalışmaların Kontrolüne Dair Yönetmelik, Resmi Gazete Tarihi: 25.06.2002, Resmi Gazete Sayısı: 24796.
  • UK Department of Health. (2000) The United Kingdom Good Laboratory Practice Monitoring Authority. Guide to UK GLP Regulations.
  • 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.
There are 24 citations in total.

Details

Primary Language Turkish
Journal Section Articles
Authors

Dilek Yalçın This is me

İlkay Açıkgöz This is me

Publication Date June 1, 2007
Published in Issue Year 2007 Volume: 27 Issue: 2

Cite

APA Yalçın, D., & Açıkgöz, İ. (2007). İyi Laboratuvar Uygulamaları. Gazi Üniversitesi Gazi Eğitim Fakültesi Dergisi, 27(2), 43-56.
AMA Yalçın D, Açıkgöz İ. İyi Laboratuvar Uygulamaları. GUJGEF. June 2007;27(2):43-56.
Chicago Yalçın, Dilek, and İlkay Açıkgöz. “İyi Laboratuvar Uygulamaları”. Gazi Üniversitesi Gazi Eğitim Fakültesi Dergisi 27, no. 2 (June 2007): 43-56.
EndNote Yalçın D, Açıkgöz İ (June 1, 2007) İyi Laboratuvar Uygulamaları. Gazi Üniversitesi Gazi Eğitim Fakültesi Dergisi 27 2 43–56.
IEEE D. Yalçın and İ. Açıkgöz, “İyi Laboratuvar Uygulamaları”, GUJGEF, vol. 27, no. 2, pp. 43–56, 2007.
ISNAD Yalçın, Dilek - Açıkgöz, İlkay. “İyi Laboratuvar Uygulamaları”. Gazi Üniversitesi Gazi Eğitim Fakültesi Dergisi 27/2 (June 2007), 43-56.
JAMA Yalçın D, Açıkgöz İ. İyi Laboratuvar Uygulamaları. GUJGEF. 2007;27:43–56.
MLA Yalçın, Dilek and İlkay Açıkgöz. “İyi Laboratuvar Uygulamaları”. Gazi Üniversitesi Gazi Eğitim Fakültesi Dergisi, vol. 27, no. 2, 2007, pp. 43-56.
Vancouver Yalçın D, Açıkgöz İ. İyi Laboratuvar Uygulamaları. GUJGEF. 2007;27(2):43-56.