Validation organisation

Another crucial problem for any neurochemical model is cause and effect. Neuroleptics have a high affinity for dopamine receptors, particularly the D2-subtype. There is also a highly significant positive correlation (r > +0.9) between this receptor binding and their clinical potency (Seeman, 1980). But, this does not necessarily implicate elevated dopamine levels as the cause of schizophrenia. Moreover, blockade of dopamine receptors happens very rapidly, whereas clinical benefits are only seen after chronic treatment. Rose (1973) has criticised the reductionist statement that an abnormal biochemistry causes schizophrenia because it relates cause and effect at different organisational levels (namely, the molecular and behavioural). But, while it can be legitimate to discuss cause and effect at the same level that chlorpromazine blocks dopamine receptors (one molecule altering the response of another), it is not valid to infer that increased dopamine activity causes schizophrenia. Put another way ... 

For standardised instrumental analytical methods, i.e. biomarkers, biosensors and bioassays, there are well-established standard protocols on the national level, e.g. under Association Francaise de Normalisation (AFNOR), British Standard Institute (BSI), DIN (German Organisation for Standardisation), etc., and all those standards are formed by ISO-Working Groups and by validation studies into ISO - and CEN - Standards. Normal accredited and well-qualified laboratories should be able to perform the monitoring. 

Once the test method has been validated, the ECVAM Scientific Advisory Committee (ESAC) produces a statement or recommendation on the use of the test method. In some cases, regulatory acceptance is achieved via adoption of the test method by a relevant European commission (e.g., a new Commission Regulation) or a new OECD Test Guideline (Organisation for Economic Co-operation and Development (OECD)). 

Does the organisation seriously address the subject of noise emissions Does the organisation maintain valid training certificates proving that personnel are trained regularly in the handling of hazardous materials ... 

IUPAC, ISO, and AOAC International International Union of Pure and Applied Chemistry, International Organisation for Standardization, Association of Official Chemists Method validation, Standardization, internal quality control, proficiency testing, accreditation 4,8, 62-71... 

FAO/WHO Codex/ CCMAS Food and Agricultural Organization/World Health Organisation Codex Committee on Methods of Analysis and Sampling Method validation 21,75-78... 

OECD (1999b) Final record First Meeting of the OECD Validation Management Committee for the Screening and Testing of Endocrine Disrupting Substances — Mammalian Effects, Tokyo, Japan, 8-10 February 1999. Paris, Organisation for Economic Co-operation and Development. 

Validation Policy Plans Training Plans GMP Risk Assessments) Validation Rationale Organisation Chart Validation Procedures Quality Procedures... 

The validation era brought with it the need for humans involved to communicate with new terminology. The purpose of this chapter has been to identify and explain the key terminology needed to understand nonaseptic process validation. A currently popular, lucid, and accurate definition of process validation itself is well-organised, well-documented common sense. 

The fibre-optic-based collection scheme developed for conventional Raman spectroscopy [29] is equally valid for SORS. In the original concept, the collection fibres (arranged in a disk pattern) were re-organised onto the spectrograph slit into a linear pattern matching the geometry of the spectrograph... 

When developing the validation plan, a decision has to be made about the manner in which the documents will be organised ... 

The guiding factor for organising validation documentation is the criticality and complexity of the system, and the type of software. Refer to Appendix D. 

Improvement schemes can be defined as a succession of individual interlaboratory studies in which several laboratories analyse the same test samples for the same characteristics (usually the content of an analyte), following a similar protocol to validate each individual step of their own analytical method (Quevauviller, 1999a). They enable laboratories to develop and validate all steps of new or existing analytical procedure(s) in adequately organised successive exercises which may be considered as preliminary studies for laboratory or method performance studies or certification of RMs (Griepink and Stoeppler, 1992 Quevauviller, 1998b). Such programmes are particularly valuable in the case of speciation studies since the analytical procedures include several complex and critical steps. 

It seems that these conclusions are also valid for the key comparisons organised by CCQM. 

Participate in a world-wide series of comparisons of standards which provide the ultimate technical validation of the CMC claims. At present there are some 400 key comparisons registered into the BIPM s database (the KCDB), conducted by the CIPM and the Regional Metrology Organisations (RMOs) ... 

Fig. 4 Elements in the proficiency testing organised to evaluate matrix bias and method validation...

The second area of VAM activity, developing the tools needed for reliable analytical measurements, has always represented the most extensive part of the programme. The emphasis lies with the development of reference methods and the production of reference materials and calibration standards. In the early days, distribution of reference materials was seen as a key part of VAM, aimed at encouraging and facilitating their use. Today, however, the importance of reference materials is widely accepted and the distribution function is undertaken as a completely separate, commercial function by LGC-Promo-chem. A very important aspect of the second area is the collaborative development of validated methods, protocols and guides working in close collaboration with both UK laboratories and overseas organisations. 

The Concept of V AM has been promoted since the start of the programme as a way of encouraging laboratories, and their managers, to adopt best practice. The message is clear by adopting six straightforward principles organisations can ensure their results are fit for purpose, demonstrate the validity of data to their customers, and achieve consistency with results obtained elsewhere. These six principles,... 

This point is a general one, independent of the specific application. The Organisation for Economic and Co-operational Development (OECD) proposed five principles within the guidelines for the validation of regulatory QSAR models (18). OECD says that a model should be associated with the following informations ... 

Guidance Document on the Validation of (Quantitative) Structure Activity Relationship [(Q) SAR] Models, No. 69 OECD Series on Testing and Assessment Organisation of Economic Cooperation and Development Paris, France, 2007. http //www.oecd.org. Accessed May 2008... 

Organisation for Economic Co-operation and Development [OECD]. 2005a. OECD principles for the validation, for regulatory purposes, of (quantitative) structure-activity relationship models. http //www.oecd.Org/document/23/0,2340,en 2649 34365 33957015 l l l l,00.html (accessed December 15, 2005). 

OECD (2003b) OECD draft report of the validation of the rat uterotrophic bioassay Phase 2. Testing of potent and weak oestrogen agonist by multiple laboratories. Paris, Organisation for Economic Co-operation and Development (ENV/JM/TG/EDTA(2003)1 http //www.epa.gov/scipoly/oscpendo/pubs/edmvac/uterotrophic oecd rodent validation p2 3 5 2003.pdf). 

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