Topical Issues

The development of bespoke (totally original) code is not only very expensive but also very hard to produce with a low level of defects. Size for size, bespoke code is much more difficult to validate to an adequate level than standard software. We might define standard software as that in widespread use in business or industry, thus providing much opportunity for innate defects to emerge quickly and be resolved either through updates or workarounds. Operating systems are, of course, the apotheosis of standard software, their 

The goal of this chapter was to show that a successful validation exercise, just like any other major project, must be built on sure foundations. Since validation involves documentation and testing of various kinds, the question arises as to whether this activity on its own is sufficient to demonstrate innate fitness for use. In the case where software forms a central part of the product being validated, such as a modern analytical instrument, manufacturing machine or other integrated software/hardware system, such activity is fundamentally limited to those parts of the code executed in the course of normal operation. This will often leave the majority of possible pathways through the code unexamined and bereft of the necessary evidence. 

UK GAMP Forum. 1998. The Supplier s Guide for Validation of Automated Systems in Pharmaceutical Manufacture, version 3. Available from the International Society for Pharmaceutical Engineering. 

ISO 8402 1994. Quality Management and Quality Assurance—Vocabulary. Geneva, Switzerland International Organization for Standardization. 

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J.A. Murphy, Free Radicals in Synthesis Clean Reagents Affording Oxidative or Reductive Termination , Pure and Applied Chemistry, Special Topic Issue on Green Chemistry, 2000, 72(7) 1327. 

This Topic issue might therefore be considered as a timely update report of the Newkome/Moorefield/Vogtle book on Dendritic Molecules published in 1996. 

Designing nanoprobes whereby imaging agents (for PET, SPECT, and/or optical imaging methods, as well as for simultaneous imaging and therapy) are anchored to (or encapsulated by) nanosize carriers is a topical issue (144). 

Croom S., 2001. Topic Issues and Methodological Concerns for Operations Management Research, EDEN Seminars, Brussels. 

After raising a selection of topical issues in this field and briefly introducing some spectroscopic and numerical techniques to probe the hydrogen bond dynamics, recent results for alcohol clusters are presented in order of increasing complexity. They are followed by some general conclusions and an outlook on future research goals. 

The growing interest in physical characterization of solid catalysts as they function has stimulated a new series of congresses, the first held in Lunteren (The Netherlands) in 2003 and the second in Toledo in 2006. The subject has been documented in recent books (B. M. Weckhuysen, Ed., In situ Spectroscopy of Catalysts, American Scientific Publishers, 2004, and J. F. Haw, Ed., In situ Spectroscopy in Heterogeneous Catalysis, Wiley-VCH, 2002) and in topical issues of journals Top. Catal. 15 (2001) Phys. Chem. Chem. Phys. 5, issue 20 (2003) and Catal. Today 113 (2006). It is our intention that our set of volumes be more nearly comprehensive than these publications, as well as providing many newer results. 

PureAppl. Chem. 2000. Special topic issue on Green Chemistry 72. 

This has been a topical issue in Madagascar recently (data exchange, benefit sharing, use of natural resources, information technology and communications, etc.), but to date, no regulations have been adopted. 

Ranking of objects on basis of expert multi-factor analysis of outstanding topical issues... 

Figure 2.4 provides an overview of the changing topical issues that have faced pharmaceutical and healthcare companies over the last 20 years. The pivotal inspections behind these topical issues are reviewed below. 

Trill, A.J. (1993), Computerized Systems and GxP — A UK Perspective Part 1 Background, Standards and Methods Part 2 Inspection Findings Part 3 Best Practices and Topical Issues, Pharmaceutical Technology International, 5 (2) 12-26, 5 (3) 49-63, 5 (5) 17-30. 

The validation of computer systems has been a topical issue for over a decade, and for many companies it is a routine topic for regulatory inspections. The importance of computer systems validation is set to continue with regulatory interest in the role of new technology and ever more pervasive use of computer systems to support the development, manufacture, and distribution of pharmaceutical and healthcare products. ... 

The Chemical Sciences Roundtable workshops foster discussion among representatives from the academic, industrial, not-for-profit, and governmental sectors on topical issues facing the chemical sciences community. The reports based on these workshops are designed to make the presentations and discussions available to a wider audience and to catalyze additional activities by individuals or organizations that have an interest in the topics. 

Bartlett, R. J., Purvis, G. D. Physica Scripts, Topical Issue on Many-Body Theory of Atomic Systems (1980)... 

This article provides an overview of the properties and occurrence of amorphous pharmaceutical materials, and outlines their key applications in dosage form development. It describes their characteristics and the fundamental scientific basis for these characteristics. It also highlights the topical issues of chemical/ physical stability and polyamorphism. ... 

Special topical issue on Nanostmc-tural Systems, Pure Appl. Chem., 2001, 72, 2002, 74. 

Frebortovd, J. Galuszka, P. Frdbort, I. In Floriculture, ornamental and plant biotechnology advances and topical issues, Teixeira da Silva, J.A., Ed. Global Science Books London, 2006 pp. 379-384. 

Abstract The protection of the coherence of open quantum systems against the influence of their environment is a very topical issue. The main features of quantum error-correction are reviewed here. Moreover, an original scheme is proposed which protects a general quantum system from the action of a set of arbitrary uncontrolled unitary evolutions. This method draws its inspiration from ideas of standard error-correction (ancilla adding, coding and decoding) and the Quantum Zeno Effect. A pedagogical demonstration of our method on a simple atomic system, namely a Rubidium isotope, is proposed. 

Hurley, S. D. and Streit, W. J., Microglia and the mononuclear phagocyte system, in Topical Issues of Microglial Research, Ling, E. A. and Tan, C. K., Eds., Singapore Neuroscience Association, in press. ... 

As the series has progressed, we have provided more volumes on topical issues and, in some cases, single author(s) volumes. This flexibility has made it possible for us to diversify the series. Therefore, the course of the series has been dictated by the workers in the field. The editor not only welcomes suggestions from the readers, but also eagerlv solicits your advice and contributions. 

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