EC verification

EC Type-examination Certification Certification of design based on testing of physical samples versus standards/essential requirements EC Verification Certification... 

EC verification provides an alternative to the model of establishing a certified production QA system. Independent testing of either all devices, or a statistically representative sample of each batch, is conducted by or on behalf of the Notified Body, which then issues a certificate of conformity for the tests conducted. This is not a popular option due to the costs involved. The procedure is not capable of providing adequate assurance as to the sterility of devices. Instead, an assurance of sterility must be based on the application of a production QA system to the sterilisation process. 

Q.l Does the EC verification mark on a product guarantee free access to the whole internal market for the product concerned ... 

Q.2 Is the EC verification mark recognized in all countries of the European Union ... 

Q.3 Is the Commission aware that, in some countries in the Union, other seals of approval are still in use in addition to the EC verification mark ... 

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances... 

The EC type-examination is the process that the manufacturer may use to obtain independent verification that a design conforms to essential requirements, when a certified QA system has not been applied to the design process. The manufacturer must submit an application to the notified body, accompanied by documentation on the device design and physical samples of the device. The Notified Body examines the... 

In the field of RM certification, NAA represents a major analytical technique. It possesses unique quality assurance and self-verification aspects. Not surprisingly, therefore, NAA has been used to certify NIST standard reference materials [470]. By analogy, NAA has also been instrumental in analysing the EC polymer reference materials within the framework of the PERM project [1]. NAA was also used to validate a TXRF procedure for the determination of additives containing Ti, Zn, Br, Cd, Sn, Sb and Pb [56],... 

In Europe Directive 2004/9/EC, on the inspection and verification of good laboratory practice, lays down the obligation of the Member States to designate the authorities responsible for GLP inspections in their territory. 

The Aimex I of the Directive 2004/9/EC consists of two parts Part A (Guides for compliance monitoring procedures for good laboratory practice) and Part B (Guidance for the conduct of test facility inspections and study audits). The provisions for the inspection and verification of GLP which are contained in Parts A and B are those contained in Annexes I and II respectively of the OECD Council Decision-Recommendation on comphance with principles of good laboratoiy practice. 

Design Qualification (DQ) is the first validation element of a new facility system or equipment, where adherence to the user s specifications and to GMP rules is demonstrated. Installation Qualification (IQ) follows with the verification of adequacy of the area, installation of equipment pipelines, utilities, instrumentation, and conformity of the material used to the project specifications. At the Operational Qualification (OQ) phase, carried out after installation of all equipment, it is verified whether the system, when in operation, complies with the acceptance criteria defined in the validation plan. Once the OQ phase is successfully finalized it is possible to proceed with the calibration procedures, operation and cleaning, operator training, and preventive maintenance program. After IQ and OQ are concluded, it is time for the Performance Qualification (PQ), with the aim of verifying that what was designed, built, and operated results in a product that meets the expected specifications. Production and QC personnel are specially trained for these assessments. The tests can be done with the product of interest or a placebo, and are related to all operations, from raw material reception to product release (EC, 2001). 

CCME 2002, available from http //www.ec.gc.ca/ceqg-rcqe/English/Pdf/GAAG Fluoride e.pdf). This may need to be followed up by the verification of unusual and potentially critical data through repeated testing. It is also essential that evidence-based decision making when deriving EQSs is fully recorded, transparent, and as consistent as possible from case to case. The draft EQS should then be subject to scientific expert peer review followed by public consultation. ... 

EU law expressly requires nonclinical (pharmacotoxicological) studies to be carried out in conformity with the provisions related to good laboratory practice set out in Directive 2004/10/EC [33] and Directive 2004/9/EC [34] on the inspection and verification of laboratory practice. 

Within the European Union, the European Commission (EC) has codified the GLP requirements for medicinal products in the Introduction and General Principles chapter of Directive 2003/63/EC [31]. Within this document it is stated that nonclinical (pharmacotoxicological) studies must be carried out in conformity with the provisions related to GLP laid down in Council Directives 87/18/EEC3 on the harmonization of regulations and administrative provisions relating to the application of the principles of GLP and the verification of their application for tests in chemical substances and 88/320/EEC4 (corrigenda 1, 2, and 3) on the inspection and verification of GLP [32,33], The OECD principles have been adopted by the European Union and published, in their revised form, in the appendix to Directive 2004/10/EC [32], The GLP Web site of the EC contains detailed reference information and links for member state GLP compliance [34],... 

The cleanliness and single crystallinity of electrode surfaces are not assumed even if the preparative steps outlined above are followed. The verification or identification of initial, intermediate, and final interfacial stmctures and compositions is an essential ingredient in our studies. The interfacial characterization methods employed to date have been conveniently classified in terms of whether they are conducted under reaction conditions (in situ) or outside the electrochemical cell (ex situ). In situ methods here consisted of cychc voltammetry (CV), EC-STM and DBMS. Ex situ methods included LEED, AES, and HREELS. 

EC Commission. Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use, April 2004, revision 1 (Brussels ENTR/CT3). 

Within the EC, existing and proposed Directives have implications for food and water microbiology laboratories with respect to standardisation methods and laboratory accreditation if there is to be mutual recognition of results within the single market. It is therefore important to be able to check both the performance of a method (national or international) as well as that of individual workers. The reference materials which have been and which will be developed and hopefully certified, will thus be available for the verification of both types of performance. 

Since the introduction of Tc-l,l-EC as a tubular radiotracer (Verbruggen et al. 1992), clinical verification of the pharmacokinetic parameters has been obtained in normal controls (Van Nerom et al. 1993) and in patients (Gupta et al. 1995 Kabasakal et al. 1995), using standard procedures and also by comparison with the reference compounds orilio-iodohippurate (OlH) labeled with iodine-125 and with " Tc-mercapto-acetyltriglycine (MAG3) (Kabasakal et al. 1995 Ozker et al. 1994 Stoffel et al. 1996). Tc-EG complex showed high similarity with OIH with respect to plasma clearance and elimination half-times (Ozker et al. 1994 Van Nerom et al. 1993). " Tc-EC was... 

The preparation of the fish extracts and the verification of their homogeneity and stability were carried out by the Danish Isotope Centre and the National Food Agency (Soborg, Denmark). The aqueous solutions were prepared at the Kemforschungsanlage (Jiilich, Germany), whereas the mussel and tuna samples were prepared at the Environment Institute of the EC Joint Research Centre of Ispra (Italy). 

European Commission. Regulation (EC) 882/2004 of the European Parliament and of The Council of 29 April 2004, on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Off. J. Fur. Commun. 2004 L65 1. 

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