A conflict of analysis: analytical chemistry and milk adulteration in Victorian Britain.

This article centres on a particularly intense debate within British analytical chemistry in the late nineteenth century, between local public analysts and the government chemists of the Inland Revenue Service. The two groups differed in both practical methodologies and in the interpretation of analytical findings. The most striking debates in this period were related to milk analysis, highlighted especially in Victorian courtrooms. It was in protracted court cases, such as the well known Manchester Milk Case in 1883, that analytical chemistry was performed between local public analysts and the government chemists, who were often both used as expert witnesses. Victorian courtrooms were thus important sites in the context of the uneven professionalisation of chemistry. I use this tension to highlight what Christopher Hamlin has called the defining feature of Victorian public health, namely conflicts of professional jurisdiction, which adds nuance to histories of the struggle of professionalisation and public credibility in analytical chemistry.

Combining ISO/IEC 17025:2005 and European Commission Decision 2002/657 audit requirements: a practical way forward.

Laboratories involved in the analyses of veterinary drug residues are under increasing pressure to demonstrate that they produce meaningful and reliable data. Quality assurance and quality control systems are implemented in laboratories to provide evidence of this and these are subject to external assessment to ensure that they are effective. Audits to ISO/IEC 17025:2005, an internationally accepted standard, and subsequent accreditation provide laboratories and their customers with a degree of assurance that the laboratories are operating in control and the data they report can be relied on. However, national or regional authorities may place additional requirements on laboratories to ensure quality data are reported. For example, in the European Union, all official control laboratories involved in veterinary drug residue analyses must also meet the requirements of European Commission Decision 2002/657/EC which sets performance criteria for analytical methods used in this area and these are subject to additional audits by national or regional authorities. All audits place considerable time and resource demands on laboratories and this paper discusses the burden audits place on laboratories and describes a UK initiative to combine these audits to the benefit of both the regulatory authority and the laboratory.

Methodologies for the transfer of analytical methods: a review.

The transfer of a method from a laboratory to a production site is an important step in the development cycle of new pharmaceutical products. Method transfers are increasingly implemented due to the economical pressure coming from the rationalization of production sites, analytical subcontracting and fusion of pharmaceutical groups. However, no official guidance regarding study design, data analysis, or decision procedures is present neither in FDA documents nor in ICH documents for method transfers. The experiments performed in such a transfer and the methodology used to accept or reject it should be fitted for purpose. In order to provide to analysts a global view of the problematic of analytical method transfer, this paper reviews the documentation available in the scientific literature about the design of transfer studies and the required sample size. Special focus is also made on the statistical methodologies available for decision making with particular emphasis on risk management. Examples of transfer of pharmaceutical, bio-pharmaceutical and biological methods published in the literature are reviewed in order to illustrate the various possibilities among the strategies for methods transfer.

GLP staff training, records and supporting documentation.

GLP is a government legislation that must be complied with when conducting safety studies for regulatory submission. The availability of documentation to verify the training and ability of staff employed in the laboratory is one of the requirements of this legislation. This article gives an overview of the use of training and training records in a bioanalytical laboratory. This article is designed to offer guidance to staff involved in GLP work and to outline some options with regard to the design of a training plan, recording of information, implenting training and reviewing records. However, the formal recording of training has benefits within any quality system, regardless of legislation.

LabCorp v. Metabolite Laboratories: The Supreme Court listens, but declines to speak.

In the United States, a longstanding legal rule exists against patenting natural phenomena. The Supreme Court recently had an opportunity to help define the boundaries and clarify the implications of this "natural phenomenon doctrine" in Laboratory Corporation of America v. Metabolite Labs., dismissed as improvidently granted. This article argues that the natural phenomenon doctrine renders both the patent claim at issue in LabCorp, and the patents that directly or indirectly claim biological correlations between genotypes and medical phenotypes, invalid or unenforceable under U.S. patent law.

Overview of mycotoxin methods, present status and future needs.

This article reviews current requirements for the analysis for mycotoxins in foods and identifies legislative as well as other factors that are driving development and validation of new methods. New regulatory limits for mycotoxins and analytical quality assurance requirements for laboratories to only use validated methods are seen as major factors driving developments. Three major classes of methods are identified which serve different purposes and can be categorized as screening, official and research. In each case the present status and future needs are assessed. In addition to an overview of trends in analytical methods, some other areas of analytical quality assurance such as participation in proficiency testing and reference materials are identified.