European Union practices

The Rules Governing Medicinal Products in the European Union, Volume 4, Medicinal Products for Human and Veterinary Use Good Manufacturing Practice. 

Until 1991, manufacturers seeking authorizations for pesticides had to fulfil country-specific requirements of validation of enforcement methods. The term enforcement method means analytical methods which are developed for post-registration control and monitoring purposes. The harmonization of these requirements was initiated with the European Economic Community (EEC) Council Directive 91/414/EEC and temporarily finalized with the Guidance Document on Residue Analytical Methods SANCO/825/00 rev. 6, dated 20 June 2000 [Santd et Protection des Consommateurs (SANCO)]. The evaluation of validation studies by the competent authority is conducted by comparison of these European Union (EU) requirements with the study results and most often without any practical experience of the method. Some details of this evaluation are discussed below. 

Field residue data, which are generated to meet requirements in the pesticide registration process, are used to regulate the use of agriculture products within the European Union (EU). This article examines the best practices to conduct crop field trials and to generate crop residue samples in Europe in order to provide part of the data that the agrochemical producers of the active ingredients must provide to the EU Commission. 

This information sheet from the Health and Safety Executive summaries the health hazards that can arise from exposure to styrene. It provides practical advance to FRP manufacturers on how to assess and control styrene levels in the workplace and how these control measures should be monitored and maintained in accordance with the Control of Substances Hazardous to Health Regulations 2002. The document applies mainly to contact moulding processes, and aims to define what level of control is currently recognised as being reasonably practicable. EUROPEAN COMMUNITY EUROPEAN UNION UK WESTERN EUROPE... 

In early 2007, the EMEA reported the analysis of GMP deficiencies in its document entitled Good Manufacturing Practice An Analysis of Regulatory Inspection Findings in the Centralised Procedure. It detailed the deficiencies reported in 435 inspections of manufacturers of medicinal products and starting materials in the European Union and third countries in the period 1995 to 2005. Altogether there were 9465 deficiencies, of which 193 were critical (2%), 989 major (10%), and 8283 (88%) others. The top 20 deficiencies are presented in Table 10.1. 

Some regulatory authorities have foreseen the future impact of TM and set up appropriate guidelines. The European Union has legislation for traditional herbal products. Another example is the Therapeutic Goods Administration of Australia, which has set up a complementary medicine section that controls the regulatory practices for TM. 

Some sectors of industry are already developing practical programmes on substitution. At the same time, expertise exists within the European Union to helpsmall and medium companies implement safer products and processes. Some governments, such as in Sweden and Denmark, already provide technical and other support to companies to help them identify safer substitutes to harmful chemicals. 

AIJN Code of Practice for Fvaluatlon of Fruit and Vegetable Juices, Association of the Industry of Juices and Nectars from Eruits and Vegetables of the European Union Brussels, Belgium, 1996. 

Compliance with the GLP principles covers many aspects of accreditation to ISO 17025. The European Union has adopted the procedures for Good Laboratory Practice of the Organization for the Economic Cooperation and Development (OECD) and calls on member states to take all measures necessary to ensure that laboratories carrying out tests on chemical products comply with the GLP principles. The OECD s GLP principles are part of the Eiuopean Commission Directive 2004/10/EC (http //eur-lex. europa.eu). 

From this and other guidelines have developed current principles of good clinical practice ( GCP ) centred on ethical review by committee, with a favourable opinion being at least a moral precondition of the commencement of any human research project. In 1989, the CPMP (the Committee for Proprietary Medicinal Products) adopted GCP guidelines (based on a previous 1987 version) for the European Union. Although they were not in themselves legally enforceable, the pharmaceutical industry saw compliance with the guidelines... 

The FDA has clarified the minimum requirements for an IND submission in three areas chemistry, toxicology reports (draft) and size (2-3 volumes, each 3" thick) in an attempt to relax current practices somewhat, to the level required for a UK CTX. However, full reports are to be provided within a short time after the initial drafts. (Conversely, however, information needed to conduct human studies in the European Union has increased, recently, with the implementation of the Clinical Trial Directive.)... 

European Union member states European Food Safety Authority, European Union No ban. Issued opinion from advisory group. Recommended a notification to public of the potential health risks and proper preparation practices Alexander et al. (2004)... 

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