Validation Reviews overview

This section gives an overview regarding the biological variation between human individuals (Section 5.4.1). Then a number of analyses performed regarding the validity of the default assessment factor of 10 are reviewed (Section 5.4.2). Finally, the key issues are summarized and our recommendations are presented (Section 5.4.3). 

The analytical method for moisture determination must be validated before use during process validation studies. There are numerous techniques for moisture analysis that range from physical methods, such as loss on drying, to chemical methods, such as Karl Fisher titration. A comparative review of the conventional techniques are presented in an overview [32], The measurement of residual moisture is lyophilized pharmaceuticals by near-infrared (NIR) spectroscopy has recently been expanded [33]. 

Anklam et al. [7] as well as Ahmed [8] recently published a comprehensive overview of different PCR assays that have been published in the literature. The authors tried to include performance data adding to the value of the review articles. The validation of PCR methods and thus the establishment of such performance criteria is still the subject of much debate. H bner et al. [9] suggested an approach for the validation of PCR assays. In general, it is currently the view of most researchers that validation of a PCR assay should not differ essentially from the validation of other analytical methods. Thus, all principles outlined in the ISO standard 17025 General requirements for the competence of testing and calibration laboratories, ISO standard 5725 Accuracy (trueness and precision) of measurement methods and results as well as the principles as laid down by Codex Alimentarius (http //www.co-dexalimentarius.net), are applicable to PCR. 

An overview of the validly published taxa that have been re-examined in recent years is presented in the following. These include species listed in the genus in its most recent review (Sour-nia 1988) and new species described after that date, with the exception of three taxa that have not been studied since their description, P. amoe-boidea Biittner, P. sphaeroidea Biittner and P. brucei Mangin. The first two of these do not have features characteristic of the genus, much the division Haptophyta, so it is likely that only the latter species may still be a valid species of Phaeocystis. The main distinctive characters of the species included in this section are summarized in a table in Jacobsen (2002). 

An overview with high-level specifications was presented by the firm in support of validation. However, this document was not a controlled record and it lacked review and approval. [FDA 483, 2001]... 

Inventory of systems System/project overviews Validation plans/reports and reviews Presentation slides Internal briefing papers Document map Trained persoimel... 

Experimental validation of CFD results is considered a prerequisite to paving the road for widespread acceptance of CFD in the chemical engineering community, especially in connection with multiphase flow applications. The authors do not intend to give here a complete review on available measuring techniques for single-phase and multiphase flows only the more advanced techniques are briefly discussed. For an overview of the latest advances realized in noninvasive measurement of multiphase systems the interested reader is referred to Chaouki et al (1997). The available experimental techniques can be classified according to the following aspects ... 

The book is divided into five sections. The overview provides both a foreword and an introduction on the economic value of African Plants and their Products with a focus on Africa. The section Traditional Medicines from Africa provide reviews on the latest uses and medicinal applications of plants mostly from South and West African countries. The section Chemistiy, Pharmacognosy and Validation of Traditional Medicines provides recent advances on science-based validation of traditional uses of African Plants and case studies of African medicinal plants in pharmaceutical preparations and recent new discoveries in natural plant products chemistiy, biology and medicine. The section Quality Control of African Natural Plant Products provides practical information on the quality, chemistiy and proximate analysis, health and nutritional value of a wide array of African plants and products focusing on the development of quality standards. Finally, the last section Applications and Commerciahzation of African Natural Plant Products highlights different uses and apphcations of plants. The book closes with chapters on economic perspectives and models of benefit sharing in Africa. 

Minerals are more the province of geology than chemistry so are perhaps outside the main subject area of this book. However, they are an active field of study where INS has much to offer. Dispersion curves and the vibrational density of states can be calculated by lattice dynamics. These are often extrapolated to the extreme temperatures and pressures present in planetary interiors so it is essential to validate the models beforehand. As in many other areas, comparison of observed and calculated INS spectra provides a rigorous test. Two recent reviews provide a good overview of this field [8,9]. 

The initial broad effort established basic foundations and served for further expansion while the principal tenets have remained valid to date. When reported in the open literature, the new large pore materials immediately attracted attention of the scientific community, especially in catalysis and adsorption fields. Subsequent effort by many groups led to unforeseen expansion not only in terms of the overall effort and abundance of materials and phenomena but also new directions pursued. There is probably close to 10,000 publications on the subject [1], This presentation will focus primarily on fundamental concepts and ideas related to synthesis. For detailed and comprehensive treatments one is referred to the review publications that have been appearing regularly [13-20], For up-to-date overview of state of the art several recent reviews are especially recommended [17-20]. 

In the following, we first briefly define testing, verification, calibration, and validation because many different, and sometimes even contradictory, definitions exist, and because we need these terms for our review and for comparing model types. Then we give an overview of the main types of population models that can be used for risk assessment, and present our review. 

Spectroscopic methods can provide fast, non-destructive analytical measurements that can replace conventional analytical methods in many cases. The non-destructive nature of optical measurements makes them very attractive for stability testing. In the future, spectroscopic methods will be increasingly used for pharmaceutical stability analysis. This chapter will focus on quantitative analysis of pharmaceutical products. The second section of the chapter will provide an overview of basic vibrational spectroscopy and modern spectroscopic technology. The third section of this chapter is an introduction to multivariate analysis (MVA) and chemometrics. MVA is essential for the quantitative analysis of NIR and in many cases Raman spectral data. Growth in MVA has been aided by the availability of high quality software and powerful personal computers. Section 11.4 is a review of the qualification of NIR and Raman spectrometers. The criteria for NIR and Raman equipment qualification are described in USP chapters <1119> and < 1120>. The relevant highlights of the new USP chapter on analytical instrument qualification <1058> are also covered. Section 11.5 is a discussion of method validation for quantitative analytical methods based on multivariate statistics. Based on the USP chapter for NIR <1119>, the discussion of method validation for chemometric-based methods is also appropriate for Raman spectroscopy. The criteria for these MVA-based methods are the same as traditional analytical methods accuracy, precision, linearity, specificity, and robustness however, the ways they are described and evaluated can be different. 

With the majority of ERP projects in the pharmaceutical industry, only relatively small changes in project direction are necessary to produce the required evidence for a validated system. The production of specifications, test plans and overview documents are all activities that appear on the standard ERP project plan. In many cases, the issue appears to be in organizing the documentation to ensure specifications are categorized into the V model categories, overview documents and summary reports are written, test evidence is collated and comprehensive Source Code Reviews are retained. 

It should be possible for a regulator to get a complete picture of the validation exercise from the Validation Plan, Validation Report and overview documents. The Validation Report should be reviewed to ensure that any changes not already documented during the project are detailed so as to give a consistent picture from planning to reporting. 

Flame atomic absorption was until recently the most widely used techniques for trace metal analysis, reflecting its ease of use and relative freedom from interferences. Although now superceded in many laboratories by inductively coupled plasma atomic emission spectrometry and inductively coupled plasma mass spectrometry, flame atomic absorption spectrometry still is a very valid option for many applications. The sample, usually in solution, is sprayed into the flame following the generation of an aerosol by means of a nebulizer. The theory of atomic absorption spectrometry (AAS) and details of the basic instrumentation required are described in a previous article. This article briefly reviews the nature of the flames employed in AAS, the specific requirements of the instrumentation for use with flame AAS, and the atomization processes that take place within the flame. An overview is given of possible interferences and various modifications that may provide some practical advantage over conventional flame cells. Finally, a number of application notes for common matrices are given. 

An excellent overview of the problem, particularly as it affects bioanalytical data and information submitted to the US FDA, was published by the Society for Quality Assurance (SQA 2000). The relevant regulatory documents on electronic documents and signatures are found as Part 11 of the US Code of Federal Regulations (CFR21 2003) and an FDA Guidance document is available (FDA 2003a). (Note that the FDA interprets the word equipment to include hardware and software as well as instrumentation.) The review of qualification of anal54ical instrumentation (Bansal 2004) includes a section on software validation and the same phases (DQ, IQ, OQ and PQ, see Section 9.5.1a) apply. 

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