Study on the proficiency testing program of pharmaceutical preparation analysis.
- Author:
Lin-Bo WANG
1
;
Mei-Cheng YANG
;
Zhu-Kang CHEN
;
Ming LU
;
Pei-Jun ZHAI
;
Gui-Liang CHEN
;
Lin-Da WANG
Author Information
1. Shanghai Institute for Food and Drug Control, Shanghai 201203, China.
- Publication Type:Journal Article
- MeSH:
Accreditation;
Captopril;
analysis;
Drug Combinations;
Drug Stability;
Hydrochlorothiazide;
analysis;
Laboratory Proficiency Testing;
Pharmaceutical Preparations;
chemistry
- From:
Acta Pharmaceutica Sinica
2012;47(6):769-772
- CountryChina
- Language:Chinese
-
Abstract:
This proficiency testing program is established to evaluate the pharmaceutical preparation analysis capacity of laboratories recommended by 18 countries and economies. It was authorized by Asia Pacific Laboratory Accreditation Cooperation (APLAC), and organized by Shanghai Institute for Food and Drug Control (SIFDC) and China National Accreditation Service for Conformity Assessment (CNAS). The 0.3sigma test is used to evaluate the homogeneity and stability of the proficiency testing sample. The results of the laboratories were assessed by Z-score. The robust average and the robust standard deviation of the participants' results were calculated as assigned value and standard deviation for performance assessment of hydrochlorothiazide and captopril using robust statistics. Thirty-three of 38 laboratories recommended by 18 countries and economies sent their results back. Twenty-four laboratories' results were observed as satisfactory. Five laboratories were identified as having reported at least one questionable result. Four laboratories were identified as having reported at least one unsatisfactory result.
