Proficiency Testing for Pharmaceutical Testing Laboratories: Assay by High Performance Liquid Chromatography
Keywords:
Proficiency Testing, pharmaceutical assay, HPLCAbstract
Proficiency testing (PT) is an important complement for quality assessment and quality system development of testing laboratories. Participation in proficiency testing program is required for laboratories seeking recognition of their competence through ISO/IEC 17025:2005 accreditation which can lead to the confidence and reliability of test results. Bureau of Drug and Narcotic (BDN) has been accredited as a PT provider according to ISO/IEC 17043:2010 since 2016 under the scope of pharmaceutical assay by High Performance Liquid Chromatography (HPLC). Gemfibrozil raw material was used as PT item in 2016. There were 95 laboratories participated in the program and 96% got “acceptable” results. The program has continued to 2017 using Hydrochlorothiazide Tablets as PT item and 69 laboratories participated in the program with 97% of “acceptable” results. Participation in proficiency testing programs, testing laboratories can evaluate their performance and improve the quality system according to ISO/IEC 17025: 2005.
References
ISO/IEC 17025:2005. General requirements for the competence of testing and calibration laboratories. Geneva, Switzerland: International Organization for Standardization; 2005.
ISO/IEC 17043:2010. Conformity assessment--general requirements for proficiency testing. Geneva, Switzerland: International Organization for Standardization; 2010.
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