Regulatory framework industry

The relationship of codes and standards to the regulatory framework should be cleady understood. By themselves, industry codes and standards have no authority. Flowever, an examination of both regulations and codes shows that the governmental jurisdictions that have authority over tanks usually... 

Good Manufacturing Practice and certification of starting materials for the industrial manufacture of medicinal products. Concept paper on a Community regulatory framework , 1995 European Commission, Directorate General IE, Industry Consumer Goods Industries III/E/3 Pharmaceuticals, July. 

The new Biocidal Products Directive is examined, which closes the gap in European legislation for products such as disinfectants and anti-foulants where there has not, until now, been a Europe-wide standard. The basic goals of the directive are to simplify and harmonise Europe s regulatory framework for biocides, and to remove trade barriers within the EU, and to improve the protection of both human health and the environment. The new directive must be enforced as national legislation in all member countries by 14 May 2000. Details are given of products defined within the directive, and ways in which the directive will be put into practice in the UK are discussed. The implications of the legislation on the industry in terms of time and money spent on testing for each active substance involved are examined. 

John A. Todhunter, Assistant Administrator EPA-OPTS, "Role of Administration and Industry in Implementing Hazard Evaluation Within a Regulatory Framework", December 1981. 

The manufacturing of the API is in principle a synthesis of fine chemicals with high quality requirements for the final product and a tight external regulatory framework. In API manufacturing, the process steps, physical and chemical characteristics of the sample and equipment are very similar to the chemical industries ... 

On 29 October 2003, the Commission adopted a proposal for a new EU regulatory framework for chemicals, the so-called REACH (Registration, Evaluation, and Authorisation of CHemicals). This new regulatory framework achieved all the objectives identified in the White Paper (EU 2001) and thus represents a model of sustainable development by pursuing its three main goals economic (industrial competitiveness), social (health protection and jobs), and environmental. 

Current practices in industrial pharmacy can now be put in perspective. Typically, the method of choice is univariate one variable at a time (OVAT). One variable is examined for a few conditions, which, in practice, are selected within a safe subset of the permissible design space. A value of this parameter is selected and kept subsequently constant. Another variable is then examined, a value is chosen, and the process continues sequentially. Intuitively, unless the target function is essentially a plane, if the end result is anywhere near the global optimum, it is only by chance. A historical reason for this dated practice is that the regulatory framework greatly discouraged implementation of the virtuous cycle mentioned above, which... 

Guidance for Industry PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (19) This guidance describes a regulatory framework that will encourage the voluntary development and implementation of innovative approaches in pharmaceutical development, manufacturing, and quality assurance. Many new... 

The regulatory framework is based on a risk management approach designed to ensure public health and safety while, at the same time, freeing industry from any unnecessary regulatory burden. 

The regulatory framework governing biological medicinal products is based on the European Community Treaty, which aims at the free movement of goods within the European Union. Although the legal base is built on the principle of free trade of medicinal products within the European Union, the essential aim of any rules governing the production, distribution, and use of medicinal products must be firmly based on protection of public health. Recital 3 of Directive 2001/83/EC notes that the objective of public health protection must be attained by means that do not hinder the development of the pharmaceutical industry or trade in medicinal products within the European Union. 

Prevention of Significant Deterioration (PSD) Of all the federal laws placing environmental controls on industry (and, in particular, on new plants), perhaps the most confusing and restrictive are the limits imposed for the prevention of significant deterioration (PSD) of air quality. These limits apply to areas of the country that are already cleaner than required by ambient air-quality standards. This regulatory framework evolved from judicial and administrative action under the 1970 Clean Air Act and subsequently was given full statutory foundation by the 1977 Clean Air Act Amendments. 

It also contains some information on the regulatory framework in these countries. There is some information about Mexico, but the self-regulatory code could not be found. In addition there are some overarching international codes of conduct, such as the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) code, the World Health Organization (WHO) guidelines and the European Federation of Pharmaceutical Industries and Associations (EFPIA). 

Hence, a regulatory framework to balance these issues and provide a framework for the low greenhouse gas emissions power industry of the future to make investment decisions will need to emerge. Future power plant owners may find the C02 transport component one of the leading issues in their decision making. 

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