Sunscreen isn't enough.

Topical sunscreens act by absorbing or scattering UV radiation and are widely available for general public use as a consumer product. Surveys carried out in the UK find that sunscreen use is regarded as the most important, and by implication the most effective, sun protection measure. But is perception borne out by reality? Sunscreens applied at the thickness tested by manufacturers need only possess an SPF of 15 to prevent sunburn even for all day exposure in tropical sunshine. Yet behavioural studies show that high SPF (>15) sunscreens do not always prevent sunburn. That the protection achieved is often less than that expected depends upon a number of factors: application thickness and technique; type of sunscreen applied; resistance to water immersion and sand abrasion; and when, where and how often sunscreen is re-applied. These factors provide ample evidence that the numerical measure of protection indicated on the product pack is generally higher than achieved in practice. This mismatch between expectation and realisation may be one contributing factor why sunscreens have been reported to be a risk factor in melanoma.     

A review of the role of DSC analysis in the design of fluorozirconate glasses for fibre optic applications

The relatively poor thermal stability of fluorozirconate glasses is a major factor preventing the realisation of their true potential for fibre optic applications. A range of methods based on both isothermal and non-isothermal DSC techniques, which can be employed to evaluate the thermal stability of fluorozirconate glasses, are described. The relevance of these thermal stability criteria to the design of fluorozirconate compositions capable of yielding high quality optical fibres is discussed.     

Cortisol-eine ausgezeichnete Testsubstanz für die Qualitätsprüfung von Einführsystemen

Cortisol is thermally unstable. It is easily decomposed by loss of ketence and water. The spectrum of the resulting 11β-hydroxy-Δ⁴-androsten-3,17-dion can be superimposed upon the spectrum of the undecomposed cortisol, which only can be obtained free of the decomposition product under carefully controlled conditions. The thermal degradation product can be eaisly detected by its molecular peak at mass 302 and a key fragment at mass 163, which are nearly absent in the spectrum of cortisol. Cortisol is therefore an excellent testing material for the quality of inlet systems.     

Long-term stability study of drug products and out-of-specification test results

A metrological approach for investigating out-of-specification (OOS) test results in long-term stability study of drug products was used. It is shown that OOS test results can indicate an actual change in a measured property of a product or be metrologically related with a certain confidence probability, i.e., be caused by the measurement problems, while the product still meets the quality requirements at the time of testing. As examples, results of testing sodium chloride injections in 500-mL plastic containers and of epinephrine (l-adrenaline) injections in 1-mL ampoules were discussed. Regression analysis of the data was performed, as well as warning and action lines for shelf life of the products calculated for relevant measurement uncertainties and confidence probabilities. Producer’s and consumer’s risks of the established shelf life values were also estimated.     

Application of quality by design to the development of analytical separation methods

Recent pharmaceutical regulatory documents have stressed the critical importance of applying quality by design (QbD) principles for in-depth process understanding to ensure that product quality is built in by design. This article outlines the application of QbD concepts to the development of analytical separation methods, for example chromatography and capillary electrophoresis. QbD tools, for example risk assessment and design of experiments, enable enhanced quality to be integrated into the analytical method, enabling earlier understanding and identification of variables affecting method performance. A QbD guide is described, from identification of quality target product profile to definition of control strategy, emphasizing the main differences from the traditional quality by testing (QbT) approach. The different ways several authors have treated single QbD steps of method development are reviewed and compared. In a final section on outlook, attention is focused on general issues which have arisen from the surveyed literature, and on the need to change the researcher’s mindset from the QbT to QbD approach as an important analytical trend for the near future.

Requirements for physical testing of rubbers and plastics

This introductory paper reviews in a general way the requirements for physical testing of rubbers and plastics. The perennial questions of why and how we test are raised and considered with reference to product examples. A grouping of physical tests is suggested based on the use and value of the information they provide and related to the reasons for testing. Particular attention is given to the role of standards and to the sometimes conflicting requirements of quality control and design.     

A combination of accreditation and certification in an evolving process at EMPA: A management system to meet ISO 9001, ISO 14001 and EN 45001

 The Swiss Federal Laboratories for Materials Testing and Research (EMPA) have established a quality assurance system based on EN 45001 which meets the requirements for accreditation of all EMPA's testing activities. As testing is only a part of EMPA's range of activities, and is performed in decentralised departments, the system does not satisfy the management needs. The fundamental reorganisation of EMPA's St. Gallen site was used as an opportunity to implement an overall process-oriented management system which also included quality and the needs for accreditation. Later, an environmental management system was added and then certified for ISO 9001 and 14001. The system consists of a "Management Manual" for the St. Gallen site and a customised "Quality Manual" for each department. One of the key elements is a comprehensive review and planning procedure covering all business aspects.     

Proficiency testing as a tool to assess the performance of visual TLC quantitation estimates

The use of rapid and inexpensive nonlaboratory-based screening tests for drug quality assessments is recommended as a component of a drug quality assurance program in poor resource settings. We have established routine Minilab test procedures to screen product quality and a proficiency testing program to determine the competency of the inspectors and reliability of results. Samples for the proficiency testing were prepared by pulverizing a standard reference tablet of the appropriate drug and making serial dilutions with starch to obtain concentrations of 0, 40, and 100%. The samples, which were labeled only with the drug name and an identifying letter, were given to inspectors for quality screening using Minilab procedures. In round 1 of the proficiency test, only 3 of 28 substandard samples were correctly identified. Round 2 of the proficiency test, which was administered after a performance qualification test for the analytical method, showed much improvement: 19 of 27 substandard drugs were correctly identified, while 5 out of 9 inspectors made the correct inference on the quality of 45 samples. However, in both rounds, 2 inspectors failed to identify substandard samples, indicating that their technical competencies need to be improved for the reliability of the results. Although the thin-layer chromatography screening methods provide a rapid means for drug quality assessment, they need to be put in the hands of competent users. The inclusion of a proficiency test in the screening program provides a measure of determining competency of the personnel and reliability of the results.     

Chemometrics-Based Process Analytical Technology (PAT) Tools: Applications and Adaptation in Pharmaceutical and Biopharmaceutical Industries

Process analytical technology (PAT) is used to monitor and control critical process parameters in raw materials and in-process products to maintain the critical quality attributes and build quality into the product. Process analytical technology can be successfully implemented in pharmaceutical and biopharmaceutical industries not only to impart quality into the products but also to prevent out-of-specifications and improve the productivity. PAT implementation eliminates the drawbacks of traditional methods which involves excessive sampling and facilitates rapid testing through direct sampling without any destruction of sample. However, to successfully adapt PAT tools into pharmaceutical and biopharmaceutical environment, thorough understanding of the process is needed along with mathematical and statistical tools to analyze large multidimensional spectral data generated by PAT tools. Chemometrics is a chemical discipline which incorporates both statistical and mathematical methods to obtain and analyze relevant information from PAT spectral tools. Applications of commonly used PAT tools in combination with appropriate chemometric method along with their advantages and working principle are discussed. Finally, systematic application of PAT tools in biopharmaceutical environment to control critical process parameters for achieving product quality is diagrammatically represented.     

Accreditation: worth the trouble?

 Since the late 1980s, much attention has been paid to the usefulness of ISO-9000 certification. At present more than 45000 companies and institutions worldwide have been granted an ISO-9000 certificate. In the field of quality assurance, however, the ISO-9000 series does not completely cover the aspect of traceability. Demonstrable traceability is a particular problem in quality assurance of products by chemical analysis. In this paper realisation of demonstrable traceability is discussed, using the field of gas analysis as an example. Attention is focused on the usefulness of accreditation for laboratories performing quality assurance analyses. The basic question is asked whether and, if so, when accreditation is worth the trouble in cases where demonstrable traceability is required. Received: 15 February 1996 Accepted: 6 March 1996     

Quality analytics of internet pharmaceuticals

Trading pharmaceutical products through the Internet poses several challenges related to legal responsibilities, good distribution practices, information content and patient use, financial implications, but also regarding product quality. One of the major concerns is the well-known phenomenon of counterfeited and/or substandard drugs commercialized through rogue Internet sites. Therefore, controlling and assuring the quality of those products has become an important and challenging task for the authorities. This review gives an overview of the different quality attributes that can be evaluated to have a complete understanding of the quality of the finished pharmaceutical product traded through the Internet, as well as the current analytical techniques that serve this objective. Aspects considered are labelling and packaging, physicochemical quality attributes, identification and assay of active substances and/or excipients, impurity profiling, biopharmaceutical testing and data interpretation.     

Quality control in residual solvent analysis: the static headspace gas chromatographic method

 Residual solvent testing of raw materials and drug products constitutes part of a quality control programme. Static headspace gas chromatography (HS/GC) is suggested in current pharmacopoeias as a general tool for residual solvent testing. But the main obstacles to using HS/GC procedures are the absence of performance tests, suitable reference solvents and matrix standards, and reference methods. Harmonized regulations for residual solvent testing allow the use of a cumulative approach to estimate the residual solvent content in drug products. The supplier data may be appropriate. Therefore, in a quality control programme the main accent is put on the definition of specification limits (in accordance with toxicological data, and the influence of residual solvents on the physical properties and stability of the product) and supplier qualification. This paper focuses on two main problems linked to supplier qualification: system performance and matrix effect. HS/GC of a mixture containing solvents of different volatility and polarity is proposed as a performance test. The test can be done in three ways in accordance with the residual solvents characteristics, the test sample solubility and the specification levels required. The use of the test as a diagnostic tool is demonstrated and sources of uncertainty of the recovery determination are discussed. Received: 12 December 1998 · Accepted: 25 January 1999     

关于高校实验中心计量认证工作的认识与实践

讨论了产品检测机构在计量认证技术考核中值得注意的几个问题和具体的实践。提供了许多宝贵经验和对策。     

Total quality management in hematology

 Healthcare is changing and clinical laboratory testing must change with it. In no discipline is this change more profound than in hematology. The principles of total quality management (TQM) including continuous quality improvement, reengineering and strategic planning can facilitate these changes. In the past, hematology has often been exlcuded from these processes due to its many manual procedures and the degree of expertise and skill needed to perform the testing. As automated technology continues to evolve, hematology testing, like other testing, will become integrated into the core, clinical laboratory. We suggest TQM can, and should, guide the way. Received: 15 April 2000 · Accepted: 19 April 2000     

Can the progress in quality management tools for POC tame the fiends from Pandora's box?

POCT provides the opportunity to significantly improve the overall quality of blood testing in an organization. The design of the product, the redesign of the testing process and the tools used to manage a completely distributed testing process, are key to the quality implementation of POCT. Both theoretical considerations and practical outcomes are discussed in this paper, using the i-STAT^® System as an example of a POCT system.     

Portable capillary LC for in-line UV monitoring and MS detection: Comparable sensitivity and much lower solvent consumption

Pharmaceutical development currently relies on quality separation methods from early discovery through to line-of-site manufacturing. There have been significant advancements made regarding the column particle packing, internal diameter, length connectivity, the understanding of the impact key parameters like void volume, flow rate, and temperature all that affects the resultant separation quality, that is, resolution, peak shape, peak width, run time, and signal-to-noise ratio. There is however a strong need to establish better alternatives to large bulky high-performance liquid chromatography racks either for process analytical reaction monitoring or mass spectrometry analysis in establishing product quality. Compact, portable high-pressure liquid chromatography can be a more efficient alternative to traditional ultra-high pressure liquid chromatography and traditional liquid chromatography. The compact versatile instrument evaluated here allows good separation control with either the on-board column with fixed ultra-violet wavelength cartridge or for use with a high-resolution mass spectrometry. Significant space reduction results in greener lab spaces with improved energy efficiency for smaller labs with lower energy demands. In addition, this compact liquid chromatography was used as a portable reaction monitoring solution to compare forced degradation kinetics and assess portable liquid chromatography-mass spectrometry capability for the analyses required for pharmaceutical drug product testing.     

Towards Total Quality Management of Chinese Medicinal Herbal Products:A Case Study of Danshen (Radix Salvia Miltiorrhiza)

The global trend of favoring therapeutic treatment and health keeping with natural medicine and dietary supplement/neutraceuticals provides golden opportunity for the re-birth of CM (Chinese Medicine) and its integration into the mainstream health care system worldwide. To develop a scientifically sound and technology-based CM industry in order to compete favorably in the world market, one needs to modernize the entire process of CM manufacturing from raw material supply to downstream product preparations. High quality and contaminant-free raw material produced under GAP (Good Agriculture Practice) guidelines is the first step leading eventually to the production of quality and safe CM products through a series of quality guidelines including GLP (Good Laboratory Practice) for chemical analysis,GcLP (Good Clinical Laboratory Practice) for clinical testing, GMP (Good Manufacturing Practice) for product manufacturing, and finally GSP (Good Sales Practice) for business transactions. These 5 P's in essence constitute the TQM (Total Quality Management) system for product development.     

Intercomparisons and development of reference materials for short-term mutagenicity testing

Summary Every new product to be put on the market must be checked by a range of testing procedures so as to assess its toxicity (directive 67/548/EEC). Results from the prescribed reverse mutation assay (Ames test) are part of the consideration of whether the introduction of the product into trade is allowed. Using the above test, European testing laboratories achieved different results for the same substances, false negative and false positive results being obtained. The Community Bureau of Reference (BCR) was requested to undertake a project on short-term mutagenicity testing in order to harmonize results at the European level. The results obtained by a first intercomparison using four direct mutagens showed that further work in this field is necessary. Before starting a second intercomparison using two indirect mutagens, a preliminary study was initiated in order to examine the influence of several important parameters. The aim of this project is to certify highly purified 2-aminoanthracene and benzo(a)pyrene for their mutagenic activity.     

Applications of Innovative Non-Thermal Pulsed Electric Field Technology in Developing Safer and Healthier Fruit Juices

The deactivation of degrading and pectinolytic enzymes is crucial in the fruit juice industry. In commercial fruit juice production, a variety of approaches are applied to inactivate degradative enzymes. One of the most extensively utilized traditional procedures for improving the general acceptability of juice is thermal heat treatment. The utilization of a non-thermal pulsed electric field (PEF) as a promising technology for retaining the fresh-like qualities of juice by efficiently inactivating enzymes and bacteria will be discussed in this review. Induced structural alteration provides for energy savings, reduced raw material waste, and the development of new products. PEF alters the α-helix conformation and changes the active site of enzymes. Furthermore, PEF-treated juices restore enzymatic activity during storage due to either partial enzyme inactivation or the presence of PEF-resistant isozymes. The increase in activity sites caused by structural changes causes the enzymes to be hyperactivated. PEF pretreatments or their combination with other nonthermal techniques improve enzyme activation. For endogenous enzyme inactivation, a clean-label hurdle technology based on PEF and mild temperature could be utilized instead of harsh heat treatments. Furthermore, by substituting or combining conventional pasteurization with PEF technology for improved preservation of both fruit and vegetable juices, PEF technology has enormous economic potential. PEF treatment has advantages not only in terms of product quality but also in terms of manufacturing. Extending the shelf life simplifies production planning and broadens the product range significantly. Supermarkets can be served from the warehouse by increasing storage stability. As storage stability improves, set-up and cleaning durations decrease, and flexibility increases, with only minor product adjustments required throughout the manufacturing process.     

Shotgun Lipidomic Analysis for Differentiation of Niche Cold Pressed Oils

The fast-growing food industry is bringing significant number of new products to the market. To protect consumers’ health and rights, it is crucial that food control laboratories are able to ensure reliable quality testing, including product authentication and detection of adulterations. In our study, we applied a fast and eco-friendly method based on shotgun-lipidomic mass spectrometry for the authentication of niche edible oils. Comprehensive lipid profiles of camelina (CA), flax (FL) and hemp (HP) seed oils were obtained. With the aid of principal component analysis (PCA), it was possible to detect and distinguish each of them based on their lipid profiles. Lipidomic markers characteristic ofthe oils were also identified, which can be used as targets and expedite development of new multiplexed testing methods.