Regulatory authorities controls

Spedficalions regarding pharmaceutical premises, personnel and procedures must be followed by pharmaceutical manufacturers, distributors and retailers if they wish to obtain and retain their licence to operate. By means of these licences, dmg regulatory authorities control the activities of pharmaceutical manufacturers, importers and distributors and companies engaged in dmg promotion and advertising. 

Under certain situations, for specific equipment configurations, it may be possible to safely operate above the NFPA limit of 60% of the LFL. If this method of operation is to be considered, system-specific test data should be generated which demonstrates dial the combusdble concentradon can be controlled in a safe manner, and only then in consultadon with appropriate company and (where required) regulatory authorities. 

Tlie views expressed in this chapter are those of the author and do not necessarily represent the views or the opinions of the Medicines Control Agency, other regulatory authorities or any of dieir advisory committees. 

Alternatively, the regulatory authority may be a department or division of the executive branch. Authorities of this type are headed by a director, who is appointed by the head of the executive branch or ministry. This structural arrangement allows the head of the executive branch/ministry greater influence or control over the decision-making and enforcement activities of a regulatory authority (22). 

The TGA in Australia, the MEB in the Netherlands and the Medicines Control Agency in Zimbabwe are financed entirely by the fees and charges they collect. Unlike the countries mentioned above, these dmg regulatory authorities have full powers to dispose of the revenue they collect. And because their financial viability depends on the revenue they generate, fees and charges reflect the real cost of services. 

In addition to controlling information used for promotional and advertising purposes, dmg regulatory authorities in the majority of the countries also provide independent dmg information. This is hue of Cypms, Estonia, Malaysia, the Netherlands, Tunisia, Venezuela and Zimbabwe. Dmg information is mainly disseminated via regular bulletins. Other bodies besides the DRA also provide independent information about dmgs. 

Such a problem is not necessarily inevitable in federal-state delegation of authority. Mechanisms exist in some countries which can provide a link in the line of command and control. In Malaysia, the chief officer of the state regulatory authority is also a member of the federal-level organization. Policy communications between the federal and state levels, such as reporting, thereby become a routine. 

Enforcement methods provided by the manufacturer are not generally tested in the laboratories of the European regulatory authorities. Very often, proposed methods are evaluated by assessing the logic of proposed procedures and only for the completeness of validation data. For this theoretical review process, as much information as possible should be available. Recovery data from many validation experiments with different kinds of matrices and the resulting chromatograms of control and fortified samples provide the confidence needed by the referee. In the following sections, the most important aspects of this evaluation will be considered. 

RCRA has a regulatory focus and authorizes control over the management of wastes from the moment of generation until final disposal. 

When applying legislation to atmospheric emissions, the regulatory authorities can either control emissions from individual points of release or combine all of the releases together as a combined release from a bubble around the manufacturing facility. 

Analytical chemistry is a critical component of worker safety, re-entry, and other related studies intended to assess the risk to humans during and subsequent to pesticide applications. The analytical aspect takes on added significance when such studies are intended for submission to the U.S. Environmental Protection Agency and/or other regulatory authorities and are thus required to be conducted according to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Good Laboratory Practice (GLP) Standards, or their equivalent. This presentation will address test, control, and reference substance characterization, use-dilution (tank mix) verification, and specimen (exposure matrix sample) analyses from the perspective of GLP Standards requirements. 

The textbook on Pharmaceutical Drug Analysis would enormously serve the undergraduates, postgraduates, researchers, analytical chemists working in the Quality Assurance Laboratories, new drug development, production and control, teaching, or regulatory authorities. 

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