European Analytical Quality Control

Gardner, M., Morin, A. and Dulio, V. (2007) Current state of the art and existing gaps in the communication of QA/QC information for the Water Framework Directive, Report under EAQC-WISE project European Analytical Quality Control in support of the Water Framework Directive via the Water Information System for Europe, Contract No. 022603 (SSPI). 

References Ihnat (1995), International Atomic Energy Agency and United Nations Environment Programme (1995), National Oceanic and Atmospheric Administration (1995), Analytical Quality Control Services (1998), Quevauviller et al. (1998a), Trahey (1998), European Commission, Joint Research Centre, IRMM (1999). 

Results of a survey of asbestos fibers in consumer cosmetic talc powders from Italian and international markets using electron microscopy, electron diffraction, and energy dispersive x-ray analysis showed that asbestos was detected in 6 of 14 talc samples from the European Pharmacopeia (Paoletti et al. 1984). Chrysotile was identified in 3 samples, 2 samples contained tremolite asbestos and anthophyllite asbestos, and 1 sample contained chrysotile and tremolite asbestos. The authors noted that, in all talc powders analyzed, fibrous talc particles frequently were present that were morphologically similar to amphibole asbestos fibers. Counting fibers as particles with aspect ratio >3 1 and width < 3 m, the percentages of particles that were asbestos fibers ranged from <0.03% to 0.13% for 4 samples, and were 18% to 22% for the other 2 samples. Paoletti et al. (1984) noted that the European Pharmacopeia, at that time, had not established analytical quality control of asbestos contamination. 

Since important decisions affecting the health and welfare of humanity must be made on the basis of analytical results, considerable effort must be directed toward assuring greater confidence in the reliability of the output of analytical laboratories. The Commission of the European Communities, after performing a study to determine the comparability of chemical analyses for drinking water quality, concluded that analytical quality control must be required as a routine component of analytical work. They state ( ), "Only the combination of intralaboratory controls of precision and accuracy complemented by interlaboratory intercomparison tests can lead to a significant evaluation and improvement of analytical results."... 

Potential hazards caused by the introduction of toxic components (especially heavy metals) in contaminated compost are frequently revealed. These typical impurities are covered by the analytical quality control of the majority of European national regulations, and will lead to the classification of the product as second or third level... 

Water samples (drinking water, rain, sea, river or waste water and others) have been characterized by ICP-MS with multi-element capability in respect to metal impurities (such as Ag, Al, As, Ba, Be, Ca, Cd, Cr, Co, Cu, Fe, Hg, K, Na, Sb, Se, Mg, Mn, Mo, Ni, Pb, Tl, Th, U, V and Zn) in many laboratories in routine mode with detection limits at the low ng I 1 range using ICP-QMS, and below by means of ICP-SFMS. Drinking water samples are controlled in respect of the European legislation (Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption). For quality control of analytical data, certified standard reference materials e.g. drinking water standard (40CFR 141.51), river water reference material SLRS-4 or CASS-2 certified reference sea-water material and others are employed. 

Although phospholipids are natural components of nearly all food products, the analysis of the phospholipid composition is of importance mainly in the certification and quality control of lecithins. According to the European Analytical Subgroup of the International Lecithin and Phospholipid Society (ILPS), there is an urgent need for a standard method for the determination of the PL composition, for this would allow a better characterization of lecithin and PL products (15,16). Besides, the nonavailability of good calibration standards is a major problem when comparing analytical results between companies. In order to try to solve the latter problem, the ILPS proposes a calibration standard whose composition is certified by 31P-NMR as an absolute tech-... 

Generally, the analysis of environmental pollutants is considered as a necessary expense that is performed solely if stated by law. With less expensive screening methods and automated modern equipment to analyze suspect samples, the cost of analysis will become much lower. Hence, the attitude towards QA would most probably be more positive and the analytical work much more reliable for the customers. This also strengthens the international competitiveness of European producers. The credibility of the entire monitoring chain (screening methods, reference and standardized methods, as well as CRMs for the quality control of these methods) lies in the adequacy and integration of all three levels of the system. The adequate development and validation of methods is a prerequisite for a harmonized measurement system [80]. 

P. Jackson, N. J. Clayden, J. A. Barnes, T. A. Carpenter, L. D. Hall, and P. Jezzard, New analytical techniques for advanced polymer composites, in A. Kwakemaak and L. van Arkel, (Eds.), Proceedings of the 12th International European Chapter Conference of the Society for the Advancement of Material and Process Engineering, Maastricht, The Netherlands, May 28—30, 1991, Advanced Materials Cost Effectiveness, Quality Control, Health and Environment, Elsevier, Amsterdam, The Netherlands, 1991, pp. 277-288. 

One of the short-term aims of the quality assurance/quality control (QA/QC) activities of the SWIFT-WFD project was the evaluation of the state-of-the-art of the analytical performances of SMETs in use in Europe, whereas one of the long-term aims was the establishment of a framework of ongoing PT schemes activities supporting the European laboratories involved in the implementation of WFD applying either classical methods or SMETs. 

The scientific goal of Working Group 1(a) has been the development and updating of quality control methods to assure safety of Tc radiopharmaceuticals for parenteral application in nuclear medicine. Scientific institutions in 12 European countries have contributed their experience and results for comparison of the available analytical methods. Some results are presented in the monographs. 

In most litmture data included in this review analytical methods were validated by analyzing reference material. Due to such selection some publications from former Yugoslav tqmblics had to be disregarded. The fact that it is not sure whether alt the studies were p ormed with adequate quality control, the comparison of the data has to be taken with some precaution. An international quality control performed in all eastern European countries would be highly welcomed. 

Institute for Reference Materials and Measurements promotes European harmonization and standardization in analytical measurements, quality control in preparation of CRMs... 

In recent years, an increasing number of pharmaceutical companies have included CE methods in early drug discovery testing and routine quality control as well as in documents for regulatory submission. CE methods are accepted by the regulatory authorities such as the US Eood and Drug Administration and the European Agency for the Evaluation of Medicinal Products and the technique has been implemented as analytical method by the United States Pharmacopeia and the European Pharmacopoeia. 

AOAC Association of Official Analytical Chemists ASQC American Society for Quality Control BCR European Community Bureau of Reference... 

Analytical methods and specifications must be established and validated so as to define and control the quality and purity of the raw materials, intermediates and the finished product. For many standard chemical raw materials, the development of specifications will not be necessary as they are already published in US and European pharmacopoeia (for example, standards for water, organic solvents and various excipients). The ultimate objective of these activities is to be able to manufacture the drugs required for clinical trials in accordance with good manufacturing practice (GMP). 

---