The Korean Journal of Pesticide Science (농약과학회지)

The Korean Society of Pesticide Science (한국농약과학회)
권호 표지

Quality Control System for Analytical Chemistry Laboratory of Pesticide Products

농약 이화학시험 분석기관 정도관리체계

  • Chang, Hee-Ra (Environmental Chemistry, Toxicology Research Center, Hoseo University) ;
  • Lee, Joon-Yeob (Environmental Chemistry, Toxicology Research Center, Hoseo University) ;
  • Lee, Young-Ju (Environmental Chemistry, Toxicology Research Center, Hoseo University) ;
  • Kang, Hye-Rim (Environmental Chemistry, Toxicology Research Center, Hoseo University) ;
  • Kim, Chan-Sub (Department of Crop Life Safety, National Academy of Agricultural Science) ;
  • Kim, Kyun (Environmental Chemistry, Toxicology Research Center, Hoseo University)
  • 장희라 (호서대학교 안전성평가센터) ;
  • 이준엽 (호서대학교 안전성평가센터) ;
  • 이영주 (호서대학교 안전성평가센터) ;
  • 강혜림 (호서대학교 안전성평가센터) ;
  • 김찬섭 (국립농업과학원 농산물안전성부) ;
  • 김균 (호서대학교 안전성평가센터)
  • Received : 2011.11.22
  • Accepted : 2011.12.19
  • Published : 2011.12.31
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Abstract

Many international organizations, such as the International Organization for Standardization (ISO) and Collaborative International Pesticide Analytical Council (CIPAC), have published a guide to quality control requirements, proficiency testing and method validation for pesticide formulation. In general, proficiency testing is to determine the performance of individual laboratories from the comparison of test results and to monitor a laboratory's performance abilities. One of quality assurance (QA) scheme would be include the validation of analytical method that implies a performance characteristics, specificity, selectivity, linearity and so on. According to many international organizations, the quantification methods of active substance in formulated pesticide products are required to be reproducible, accurate and precise. This study was conducted to compare the international guidelines for the quality control, proficiency testing and method validation of analytical laboratories and to propose a general guidance for the establishment of quality control system in the analytical chemistry laboratories of pesticide formulation in domestic.

분석표준화 관련 국제기관인 ISO, CIPAC 등은 농약제품 시험기관에 대한 정도관리(QC), 숙련도 시험 및 분석법 검증을 수행하기 위한 요구조건을 지침서로 제시하고 있다. 일반적으로, 숙련도 시험은 시험기관의 분석능력 평가를 위하여 시험기관간 비교시험을 바탕으로 시험기관의 수행능력과 기술능력 정도를 판단할 수 있다. 분석법 검증 절차는 정도관리(QC)에서 중요한 단계 중 하나로 특이성, 선택성, 직선성 등의 항목들이 포함되며, 대부분의 국제기관이 농약제품 중 주요성분에 대한 정량분석법에서 재현성, 정확성 및 정밀성 등을 요구하고 있다. 본 연구에서는 농약 이화학시험 분석기관의 시험연구과정 및 결과에 대한 신뢰성을 높이기 위해 국내 외 정도관리에 관한 지침서를 비교 검토하여 국제적으로 표준화된 지침서에 적합한 구체적이고, 효율적인 농약 이화학시험 분석기관의 농약분석법 검증절차 및 시험기관 정도관리 체계(안)를 제안하고자 한다.

Keywords

References

  1. Balayinannis, G., H. Karasali, H. Anagnostopoulos, and A. Hourdakis, (2004) International requirements for "single-laboratory" validation of analytical methods for pesticide formulations, 3rd European Conference on Pesticides and Related Organic Micropollutants in the Environment.
  2. CDER, FDA (2001), Guidance for Industry-Bioanalytical Method Validation.
  3. CIPAC/FAO/WHO (2005), Quality control of pesticide products-Guidelines for National Laboratories.
  4. CIPAC 3807, Guidelines on method validation to be performed in support of analytical methods for agrochemical formulation.
  5. COPR (2002), Guidelines for validation of analytical methods for non-agricultural pesticide active ingredients and products.
  6. FAO/WHO (Reprinted 2004), Pesticide specifications manual on development and use of FAO and WHO Specifications for pesticides.
  7. FAO/IAEA (2006), FAO/IAEA Workshop on quality assurance/quality control measures in pesticide residue analytical laboratories.
  8. FAPAS (2002), Protocol for the organization and analysis of data, sixth edition.
  9. ISO/IEC 17043 (2010), Conformity assessment-General requirements for proficiency testing, first edition.
  10. ILAC (2007), ILAC guidelines for the requirements for the competence of providers of proficiency testing schemes, ILAC-G13:08.
  11. IUPAC (2002), Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC Technical Report), Pure Appl. Chem. 74, pp. 835-855. https://doi.org/10.1351/pac200274050835
  12. IAEA (2009), Quality control of pesticide products, IAEA-TECDOC-1612.
  13. International Organization for Standard. ISO 17025 (2005): General requirements for the competence of testing and calibration laboratories.
  14. IUPAC (2006), The international harmonized protocol for the proficiency testing of analytical chemistry laboratories (IUOAC Technical Report), Pure Appl. Chem. 78, pp. 145-196. https://doi.org/10.1351/pac200678010145
  15. US EPA (1999), Protocol for EPA approval of New Methods for organic and Inorganic Analytes in Wastewater and Drinking Water.
  16. 고문환, 권순익, 남재작, 김유학 (2005) 분석정도관리 지침 설정 연구, 국립농업 과학원 농업환경연구, pp. 177-194.
  17. 국립환경연구원 (2009) 측정분석기관 정도관리의 방법 등에 관한 규정, 국립환경 연구원 고시 제2009-32호.
  18. 국립환경과학원 (2009) 환경측정분석기관 정도관리 운영 지침, 국립환경과학원 예규 제501호.
  19. 농업과학기술원 (2002) 농업과학기술원 품질매뉴얼.
  20. 농업과학기술원 (2003) 농업과학기술원 표준운영지침.
  21. 농촌진흥청 (2010) 농약 시험연구기관 지정기준, 농촌진흥청 고시 제2010-21호.
  22. 식약청 (2007), 한약재 분석기관 정도관리 표준화 기법 연구.
  23. 식약청 (2009) 식품의약품안전청 고시 제2009-179호, 검사능력관리규정.
  24. 한국인정기구 (이하 "KOLAS") KS Q ISO/IEC 17025해설서, 기술표준원 고시 제2011-324호.