Good information practices

The Assembly appealed to the pharmaceutical industry, health professional and consumer organizations, and other interested parties to promote the formulation and use of good information practices consistent with the principles of the WHO Ethical Criteria for Medicinal Drug Promotion monitor and report problem cases and aspects of cross-border advertising, promotion, and sale of medical products using the Internet and maintain legal and ethical standards in these activities. 

Other offices within ODER may become involved in the review process via consults. Eor example, the Office of Epidemiology and Biostatistics analyzes statistical data, the Office of Research Resources provides bioavailabiHty reviews, and the Office of Compliance determines from the results of inspections whether the firms meet EDA s Current Good Manufacturing Practice (cGMP) regulations. Advisory committees composed of independent experts are often asked to meet and further analyze the data. Often they also advise as to what additional data and information may be needed. After PDA s review is completed, PDA issues either a Summary Basis of Approval (SBA) for the dmg or a recommendation against approval. If approved, PDA releases the SBA and a summary of the safety and effectiveness data to the general pubHc. 

Smaller companies can benefit by the assistance offered by these larger corporations. It is clear that access to information is of major importance when implementing efficient pollution-preventiou programs. By adopting such programs, industiy is affirming pollution prevention s application as a good business practice and not simply a noble effort. 

When setting the goals of a measurement project, it has to be asked, What exactly has to be determined. What are the final quantities required and what is the inaccuracy that can be tolerated in these quantities Only when these factors are known can an analysis be made, where the quantities to be measured and the measurement accuracy of each quantity are defined. This analysis is based on the mea surement method selected, and on the computation of measurement uncertainties. Usually the analysis of measurement uncertainties is made after monitoring however, making it beforehand is part of good planning practice. This approach ensures that the correct information with the desired accuracy is achieved. 

In order to use any of the results obtained by objective methods as the basis for the acceptance or rejection of a product, there must be available reliable information as to the relationship between the values obtained and organoleptic quality in terms of consumer acceptance and utility. Where standards are based upon measurement of such labile constituents as ascorbic acid or sugar, a knowledge of the normal values for good commercial practice is necessary. Such values have not yet been adequately established. This should constitute a useful field for research of inestimable value to the industry. 

The manufacture of all investigational medicinal products (including placebo) that are intended for a clinical trial must be authorised and conducted according to Good Manufacturing Practice (GMP). This should be supervised and certified by a Qualified Person . An import authorisation is required for any product from outside the EU, which should also be manufactured to GMP standards. (See Ghapters 11 and 12 for information on GMP, manufacturing authorisations and Qualified Persons.)... 

EURACHEM is a network of organizations in Europe, having the objective of establishing a system for the international traceability of chemical measurements and the promotion of good quality practices. It provides a forum for the discussion of common problems and for developing an informed and considered approach to both technical and policy issues. 

At this stage in planning, the essential study design information listed below should be determined and a written study plan (i.e., protocol) including these key study details prepared. A formal, pre-approved study plan is required for field soil dissipation studies conducted under Good Laboratory Practice (GLP). A written study plan for non-GLP studies is highly recommended since the document serves as valuable guidance for study personnel. 

Danzer K (1993) Information content of an analytical result and its assessment by interlaboratory studies. IDF Special Issue 9302 Analytical quality assurance and good laboratory practice in dairy laboratories. IDF, Brussels... 

Analysts like to make chemical measurements to the highest quality they can, and this is possible with modem instrumentation and good analytical practice. Chemical parameters are generally measured more accurately and reproducibly than parameters measured in biological systems, and the results are more reliable than values calculated by software from structure alone (e.g., calculated log P, pKa). Of all the information available to medicinal chemists, measured chemical parameters are probably the most reliable. With these thoughts in mind, it makes sense not to... 

In design it is typical that the same mistakes are done again since the use of available information is not organized. The use of case-based reasoning enhances the reuse of available experience, which reduces the possibility that the same errors are done more than once. In this work CBR was used for the evaluation of the inherent safety of process structure. The casebase was collected from design standards, accident documents and good engineering practice. 

To date, the Part II Programme has focused upon four major projects (1) The development and implementation of a set of Principles of Good Laboratory Practice (GLP s) (2) Resolution of issues concerning Confidentiality of Data (3) Development of a Glossary of Key Terms and (4) Development of guidelines and other procedures for the exchange of information (e.g., re test data, the export of hazardous chemicals, and the labelling of hazardous chemicals). 

The Directive contains these other requirements concerning toxicity information and test data (1) Notifications must include descriptions of the studies conducted and methods used (Article 6(1), and Annex VII, Introductory Statements) (2) The tests must be performed according to the methods specified in Annex V (Article 3(1)), and must be "recognized and recommended by the competent international bodies where such recommendations exist" (Annex VII, Introductory Statements) (3) The persons who carry out the tests must comply with the principles of current good laboratory practice (Annex VII, Introductory Statements) and (4) The notifications must include the composition of samples used in testing, and the name of the persons responsible for carrying out the studies (Annex VII, Introductory Statements). 

Barton, B. (1998). International Conference on Harmonization good clinical practices update. Drug Information J. 32 1143-1147. 

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