Inspections European

In Austria, as well as all over Europe, the first and repetition tests of all pressure equipments including steam drums are required for security reasons within fixed time intervals. These repetitive inspections are done differently in the most European countries, but most time these inspections include, according to the European Pressure Equipment Directive" and the specific national law any kind of over-pressurisation (e.g. hydrotest) and visual inside inspection. 

The paper presents the results from systematic comparisons of contrast and resolution obtained with different types of radiation sources on steel thicknesses from 5 to 40 mm. These results have been taken into account with the definitions of the European standard for radiographic inspection of weldments (EN 1435) that is approved since 1997. Conclusions from practical investigations on pipe line sites, in petrochcemical plants and in nuclear power stations will be discussed as well. Furthermore, the presentation will stipulate a variety of advantages obtained from the new source in terras of coUimation and radiation protection. 

The three-part draft of the radioscopy standard pr EN 13068 is ready for the necessary european inquiries. This standard covers the requirements placed on the imaging system, the checking procedures as to the performance of the entire system and also the specifications of user guidelines for certain inspection tasks. The standard remains open to the definition of new inspection classes for future application cases. 

Computed Tomography of high performance for the inspection of large objects 7 European Conference for Non-Destructive Testing (ECNDT), these proceedings... 

The method was applied for determination of the quality of the detection media on test pieces following the type testing of the European standard [4] in order to check the validity of the method. The other application was the determination of the visibility in dependance of the variations of the inspection parameters (application of the detection medium, magnetization, inclination, viewing conditions) in a range which may appear in the practical inspections. The results leads to conclusions on the visibility level which is a measure of the probability of recognition for the indication that means of the reliability of the method. 

Hillger, W. Inspection of Concrete by Ultrasonic-Pulse-Echo-Technique, In Proceedings of the European Conference on Non Destructive Testing, Nice 1994, pp. II59-II63... 

R. A. Murgatroyd, G.M. Worrall, und S. Crutzen Lessons leamt from the RISC 111 study of the influence of human factors on inspection reliability. 6 European Conference on Nondestructive Te.sting, Nice. 1994, Vol. 2, p 989-993... 

Insofar as Ultrasonic Array probes have come onto the market from several years and are now moving from prototype stages into industrial tools for on-site inspections, methods and tools for acoustic characterization is becoming a real concern. Furthermore, the lack of standards, either national or European, enhances the needs for guidelines proposal. 

Inspectors findings and observations Relevant headings from The Rules Governing Medicinal relevant to the inspection and Products in the European Community, Good deficiencies Manufacturing Practice for Medicinal Products Vol. IV. (Guide to GMP, Basic Requirements, relevant for scope of inspection). ... 

Netherlands drug regulation now follow European Union rules. For example, GMP inspection is based on the 1983 European Union guidelines for GMP. Since 1 January 1995, a European procedure for registration has operated in the Netherlands. Now two types of trade licences exist a European licence and a national licence. Products with a European licence may be sold throughout the whole European Union, while the national licences are only valid for the country in which the licence was issued by means of the national registration procedure. 

Australia has a formal process for adopting European guidelines for drug development and evaluation, including the ICH guidelines. It also has bilateral agreements with a number of countries, and its membership of the Pharmaceutical Inspection Convention allows it to exchange GMP information with other members. 

Several countries (Cyprus, Estonia, Venezuela and Zimbabwe) have adopted the WHO GMP guidelines (25) as their statutory GMP standards. Australia has its own GMP guidelines. Malaysia uses the GMP guidelines of the ASEAN (26). The Netherlands has adopted the European Union guidelines on GMP inspection (27). The majority of the countries have also developed SOPs for their inspectors, as indicated in Table 7.1. Australia, Cuba, Cyprus, Malaysia, Uganda and Venezuela have not developed guidelines for GDP. 

In Tables 6.3 and 6.4 RMs of three major producers are mentioned, i.e. the World Health Organization (WHO, International Standards), BCR (European Union, CRMs) and the National Institute of Standards and Technology (NIST, USA, SRMs). Some important national producers of clinical reference materials are the Chemicals and Inspection Testing Institute (CITI, Japan), National Institute for Biological Standards and Control (NIBSC, UK), and Deutsche Gesellschaft fiir Klinische Chemie (DGKC). There are numerous commercial producers of secondary reference materials. 

Local certification has a number of advantages, not least that it is one way to reduce costs to producers in developing countries via locally determined fees reflecting local incomes (Barrett et al., 2001). To be accepted by the European Union (EU), local certification bodies are required to demonstrate that their standards of organic production and inspection are equivalent to EU regulations. The standards need not necessarily be identical, however, and as such this means more locally appropriate standards can be set in place. For example, local certification bodies may well allow the use of such natural pesticides that would not normally be allowed under EU Standards (Myers, 2000). 

Lists of field-test notifications in the European Union, the USA, Canada, Australia and Japan respectively. Available from http //engl.jrc/it http //www.nbiap.vt.edu/ http // www.inspection.gc.ca/ http // www.health.gov.au/ogtr/index.htm www. s. affrc.go. jp/docs / sebtan / eguide / edevelp.htm. List of field tests applications for many countries in Asia, South America and Africa are available from http //binas.unido.org/binas/home/ php. 

In Europe, inspections are conducted by member states on behalf of the European Union. For drugs approved under the centralized procedure, inspections are coordinated by the European Medicines Agency (EMEA refer to Sections 7.3 and 8.3). For countries that are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S see Section 7.13), there is mutual recognition of inspections performed by members. 

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