Verification of compliance

The verification of compliance with the standards of good clinical practice and the need to subject data, information and documents to inspection in order to confirm that they have been properly generated, recorded and reported are essential in order to justify the involvement of human subjects in clinical trials. 

Verification of compliance of investigational medicinal products with good clinical and manufacturing practice... 

At the request of the Agency, within the framework of its powers as provided for in Regulation (EEC) No 2309/93, or of one of the Member States concerned, and following consultation with the Member States concerned, the Commission may request a new inspection should verification of compliance with this Directive reveal differences between Member States. 

Careful records must be kept to enable verification of compliance. Each lot of wine must be traceable back to the grapes and vineyard. Tanks must be carefully gauged and the capacities recorded on them. If the wine is to be labeled "estate botded," not only must the wine be fermented, processed, and bottled by the state winery at their listed address, but the vineyard must also be owned or controlled by that winery. Other label terminology, subject to some further intricacies, are "produced," ie, fermented 75% or made into a different class of wine "prepared," "vinted," or "cellared," ie, subjected to cellar processing or aging without changing the class of wine "blended," ie, combined at the stated address, wines (probably purchased) of the same class and type and "botded" or "packed" by the stated winery. 

The entry into force of the 1993 CWC on 29 April 1997 was unique in the history of arms control. This agreement both banned an entire class of weapons and simultaneously addressed chemical proliferation concerns. It was not, however, the attention to non-proliferation that made the Convention unique, rather that the CWC incorporated an elaborate international system for verification of compliance.1... 

The States Parties to the CWC have established the Organization for the Prohibition of Chemical Weapons (OPCW www.opcw.org) to achieve the object and purpose of the CWC, to ensure the implementation of its provisions, including those for international verification of compliance with it, and to provide a forum for consultation and cooperation among States Parties (SPs). All SPs to the CWC... 

The verification of compliance with the specific migration limits (SML) provided in the Directives may be replaced by the verification of compliance with the maximum permitted quantity of substance in the finished product (QM), which corresponds to the SML. The correspondence between the specified SML and the QM shall be established by a calculation based on adequate experimentation of the finished product or by the application of generally recognized diffusion models. However, if the limit of QM is exceeded, for a judgement of non compliance of the material or article, it is necessary to obtain a confirmation that the SML has been exceeded . 

Because arms control treaties are agreements between adversaries, a central feature of them are provisions for verification of compliance. Each side may believe... 

ISO certification is not an assurance of compliance with GMP and is not a replacement or substitute for verification of compliance with GMP. 

G. Inspections, Verification of Compliance of Investigational Medical Products with Good Clinical Practice and Good Manufacturing... 

The report indicates elements as being in place in more that 50% of the 42 countries for most of the milestones in features 1 and 4, and better than 30% implementation of the milestones in features 5 to 7. The lowest level of implementation is for verification. Only 7% of the countries have begun external verification of compliance and performance, and are making the results public. 

On this latter point see T. Bernauer, Verification of Compliance with the Biological Weapons Convention Developing Countries Between Passive Participation and Obstruction, in Oliver Thranert (ed.), The Verification of the Biological Weapons Convention Problems and Perspectives, Report No.50 (Bonn Friedrich Ebert Foundation, 1992), pp.55-67. 

Verification of compliance with instructions issued with regard to storage, manufacture and packaging. 

The organophosphorus nerve agents and their analogues have been well characterized by infrared (IR), nuclear magnetic resonance (NMR) and mass spectrometry (MS). In recent years, efforts have been made to compile comprehensive spectroscopic data bases in support of analysis required for verification of compliance with the Chemical Weapons Convention (see Section XIV). Compilations of spectroscopic data are included in the series of Blue Books for the verification of chemical disarmament, published by the Ministry for Foreign Affairs of Finland "". These volumes address the application of spectroscopic and chromatographic techniques to verification analysis ... 

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. 

Nations currently implicated with chemical and biological weapons (ie, Iraq and Libya) also signed the protocol, raising questions about the agreement s true effectiveness. Verification of compliance was not addressed. 

The CWC provides for routine and challenge inspections to assist in the verification of compliance w ith the Convention. Routine inspections of declared facilities are mandated by the Convention. In accordance w ith CWC provisions, challenge inspections may be conducted at a facility w here a Party suspects illegal activities. The CWC does not include a specific list of controlled chemicals or equipment. It does contain an Annex on Chemicals in which are listed three Schedules of toxic... 

Common sense has led to simple rules that are the result of the long history of humankind activity that history is constantly evolving, and the activities are always under diversification and specialization. These rules are deeply rooted in humankind, but they do not have absolute value, as they might require verification of compliance with a specific problem. Eor example, humankind has always been led to distinguish between good and bad, to make comparisons and then performance rankings in this way, different materials are ranked, and scales of resistance are devised for different environments. These scales are not absolute rather they have relative value, related to a specific problem, and they may be generally valid but not necessarily always true. 

The pyrotechnist s relation to the pyrochemically active materials in a formula depends on the specific purpose For the production to prescribed specifications of a standardized item, he is mainly concerned with obtaining the materials promptly From commercial sources and in the verification of compliance of the ddivered materials with the specifications, In a developmental effort the emphasis is on the experimental study of different grades of known and proven materials in varying proportions. Final y, in research as well as in development of new types of devices, he may also consider substances formerly not regarded as useful for pyrotechnics. 

When the verification of compliance is based on full scale testing, the evaluation of the loss of shielding may be made by putting a suitable radioactive source into the specimen and monitoring entirely the outside surface with an appropriate... 

The Chemical Weapons Convention (CWC) is the strongest of the arms-control treaties that outlaw a specific class of weapons. The Organization for the Prohibition of Chemical Weapons (OPCW) in The Hague is responsible for inspection and verification of compliance with the provisions of the CWC [25]. The United States has not fully supported the OPCW in its difficult tasks of inspection and in urging nations to comply with the CWC. 

Derivation of and verification of compliance with waste acceptance requirements... 

Such mathematical tools as statistical tests and uncertainty evaluation are prerequisite to the practical application of an analytical result. In any situation involving verification of compliance with conventions, agreements, regulations, or laws, analysis is expected to provide the meaningful and objective criteria required for assessing the material facts. This means that observed analytical values must be supplemented with quality criteria applicable to the analytical procedure itself, such as the limit of detection, limit of determination, standard deviation, and measurement uncertainty. 

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