Accreditation and Quality Assurance (v.13, #8)
“Errors” continue to lead a persisting life by Paul De Bièvre (429-430).
Historical incidents leading to the evolution of good manufacturing practice by M. Saeed Arayne; Najma Sultana; M. Kamran Zaman (431-432).
The concept of good manufacturing practice (GMP) is not new; its roots are very old. The incidents that gave birth to the concept of GMP are summarized in this article. The journey from the FDA toward GMP is highlighted in chronological order. These regulations are mandatory for pharmaceutical industries in order to manufacture quality products.
Keywords: GMP; FDA; WHO
Analysis of a copper alloy: Comité Consultatif pour la Quantite de Matière (CCQM) pilot study P76 international intercomparison by Sebastian Recknagel; Ralf Matschat (433-441).
The capabilities of National Metrology Institutes (NMIs) and selected outside “expert” laboratories of determining the mass fractions of the main and minor elements Cu, Pb, Sn, Fe, and Ni in a lead-containing brass were assessed. This pilot study P76 was organized as an activity of the Inorganic Analysis Working Group of CCQM and was piloted by the Federal Institute for Materials Research and Testing (BAM). In total 12 laboratories (four NMIs and eight outside labs) submitted results, some of them more than one set of results per element. The laboratories were free to choose any analytical method they wanted to use for the analysis. Consequently various methods of measurement were employed: inductively coupled plasma optical emission spectrometry (ICP–OES), inductively coupled plasma mass spectrometry (ICP–MS), instrumental neutron-activation analysis (INAA), titrimetry, flame atomic-absorption spectrometry (FAAS), spectrophotometry (MAS), electrogravimetry, and gravimetric analysis. After testing for homogeneity within BAM, a certified reference material of lead-containing brass was used as test sample without informing the participants about the source of the material. The agreement of the results for all elements investigated was acceptable and mean values calculated from the results of all participants were close to the certified mass fractions of the CRM used as test sample. No statistically significant differences between the results of the NMIs and those of the non-NMIs could be observed.
Keywords: Copper alloy; Brass; International intercomparison; Consultative committee for amount of substance––metrology in chemistry (CCQM); Pilot study
A definitive RNAA method for determination of selenium in biological samples: uncertainty evaluation and assessment of degree of accuracy by Ewelina Chajduk; Halina Polkowska-Motrenko; Rajmund S. Dybczyński (443-451).
This article describes work on the development of a highly accurate RNAA method for determination of selenium in biological samples. The analytical post-irradiation procedure is based on a combination of cation-exchange and extraction chromatography with final selective and quantitative fixation of selenium on a column packed with 3,3′-diaminobenzidine (DAB) supported on Amberlite XAD4, followed by gamma-ray spectrometric measurement. The suitability and accuracy of the method was demonstrated by analysing CRMs with certified selenium content. The uncertainty budget for Se determination in standard reference material Peach Leaves NBS 1547 was estimated; the combined standard uncertainty was calculated as 1.7%. The described method fulfils all the criteria for definitive methods. It was subsequently used for determination of selenium in biological materials intended as new CRMs and proficiency test samples.
Keywords: Selenium; Radiochemical neutron-activation analysis; Highly accurate method; Definitive method; Proficiency testing
Evaluation of analytical instrumentation. Part XXIII. Instrumentation for portable X-ray fluorescence spectrometry (453-464).
The reports of this series tabulate a number of features of analytical instruments that should be considered when making comparison between various systems. Scoring these features in a rational manner allows a scientific comparison to be made between instruments as an aid to selection. This is the XXIII report of the series and deals with instrumentation for portable X-ray fluorescence spectrometry.
Keywords: Instrumentation; Overview; Evaluation; X-ray fluorescence spectrometry
Teaching metrology and quality in chemistry based on methods of mathematical statistics and e-learning by Ilya Kuselman (465-472).
Chemistry students do not usually have the necessary background in mathematical statistics to study metrology and quality principles in chemistry. Even when the students have studied mathematical statistics, it is helpful to refresh their statistical knowledge, focusing on specific applications to metrology and quality in chemistry. Therefore, when planning a course for teaching metrology and quality it is important to achieve a harmonized interaction of metrological and quality issues with the supporting statistical issues. Additional possibilities for learning the relevant subjects originate from the Internet (e-learning). Such a lecture course developed and delivered during the five years since 2003 at the Hebrew University of Jerusalem is discussed in the paper.
Keywords: Teaching chemistry students; Metrology in chemistry; Quality principles; Mathematical statistics; e-Learning
Built-in quality systems in regulated contract research organizations (CRO) conducting bioequivalence studies: a regulatory science perspective by Rabab Tayyem; Reema Tayyem; Naji Najib; Jaafar Tamimi; Mukhtar Shihabeddin (473-477).
As contract research organizations are now familiar with GXPs and have become more popular for conducting bioequivalence studies, it is very important that the sponsor has the assurance that the study has been conducted not only to the highest standard of science but also in compliance with regulatory requirements. The dynamic role of quality personnel requires alert knowledgeable people to recognise all the issues which arise and take the proper actions—experienced persons can detect and rectify these. On the basis of equality, for quality system personnel and scientists a firm grasp of regulatory science is needed to succeed. It must be remembered that compliance is monitored by adherence to regulatory standards, whereas the regulatory bodies review the appropriately implemented regulatory science principles.
Keywords: Bioequivalence study (BES); Generic product; Contract research organizations (CROs); Good practices (GXP)
Do we need to rethink collaborative trials? by Michael Thompson (479-482).
The currently recommended design of collaborative trials (interlaboratory method performance studies) is examined in relation to the usefulness of the resulting statistics. It is suggested that larger experiments, without duplicate analysis, would be more informative.
Keywords: Collaborative trial; Repeatability; Reproducibility; Design
A control chart based simply on biological variation is not enough by C. M. Van Campenhout; J.-C. Libeer (483-484).
Response to the Letter to the Editor “A control chart based simply on biological variation is not enough” by Abdurrahman Coskun; Mustafa Serteser; Arno Fraterman; Ibrahim Unsal (485-486).
Elisabeth Prichard, Vicki Barwick: Quality assurance in analytical chemistry by Roman Klinkner (487-488).
Congress, conferences, workshops and courses (489-490).