Analytical protocols external

However, the problem of analytical transferability remains. The optimal, but usually very unrealistic, situation assumes that the analytical methods, including their calibration and quality assurance, are identical in the laboratories. A more pragmatic approach involves standardization of analytical protocols, common calibration, design of a sufficiently efficient external quality control scheme, and the use of mathematical transfer functions if the results still are not directly comparable. 

The primary purposes for which reference materials are employed are encompassed within the laboratory Quality Assurance Procedures. Quality assurance comprises a number of management responsibilities which focus on how the laboratory is organized, how it deals with situations, how it interacts with users, together with analytical responsibilities re internal quality control and external quality assessment (Sargent 1995 Burnett 1996). Ideally each component follows a documented protocol and written records of all activities are maintained. 

Partial or complete re-validation is another precedented approach to method transfer. Those variables described in method validation guidance documents (ICH Q2B, 1996 USP, 2012c) that are likely to be impacted by method transfer, should be assessed and documented (transfer or validation protocol). Agut et al. (2011) indicated that, in the changing industry model with the increased outsourcing of R and D activities (alliances, outsourcing, etc.), method re-validation may constitute, in some cases, an efficient approach when the transfer is performed from the Analytical Development Laboratory of an external partner who does not share exactly the same environment (validation standards, analytical culture or traditions , equipment, etc.). ... 

A lot of dermo-cosmetic creams provide antioxidants to skin, in order to protect it from external aggressions. The choice of the active species, the determination of their concentration and the study of their possible interactions require the development of analytical techniques. Electrochemical studies dealing with the analysis of creams systematically involve modification of the sample by expensive operations dilution, extraction, filtration, heating, etc. [24,25]. These protocols do not allow the study of the overall interactions between the components. Moreover, the evaluation of the variation of the properties of the cream is difficult because of the low resolution time of the measurements. 

Quality assurance is about getting the correct result. In environmental analysis and monitoring, this involves several steps, including sample collection, treatment and storage, followed by laboratory analysis. A complete environmental protocol is shown in Figure 2.1. It is likely that the variation in the final measurement is more influenced by the work external to the analytical laboratory than that within the laboratory. Two important terms in quality assurance are accuracy and precision. 

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