Regulatory environment authorities

The goal of this section was to outline current differences between the implementation of process analytics in the chemical and pharmaceutical industry, specifically in the areas of business model, technology and regulations. The reader of this chapter should be aware that this status quo is changing rapidly in the pharmaceutical industry due to a changing business cUmate, combined with a more technology-aware regulatory environment in the major pharmaceutical markets. The authors of this chapter would expect that future editions of this book would see major revisions to this comparison of the industries. 

The most important of these is the regulatory environment in which the industry works. In a series of judgements resulting from isolated cases of poor laboratory practice the regulatory authorities of many countries, particularly the United States, have defined a strict code of practice for the industry to ensure that the highest standards of development and manufacture are observed by all... 

A product found to be unsuitable for retrospective validation because of a revised manufacturing process is a likely candidate for prospective validation, which is beyond the scope of this chapter [1], Such a discovery, however, should be brought to the attention of the appropriate authority. In today s regulatory environment ignoring the matter would be imprudent. 

A ninth chapter, guest-authored by Carl A. Rockburne, a retired Canadian trade console and regulatory consultant, compares the FDA process with those in Canada, the European Union, Japan, and Australia, the four other major regulatory environments. Fie has included FDA documents describing the regulatory harmonization process in his chapter. 

In the United States, the regulatory environment allowing the development of drug safety evaluation as a distinct discipline began with the Food and Drug Act of 1906. This act provided governmental control over food contaminants, but provided no authority to ensure the safety of new drugs. 

Overview of Regulatory Environment/Background Regulatory Authorities Regulatory Requirements and Procedures Application for a Marketing Authorization (MA)... 

Tables 2.6 and 2.7 give examples of the modes of action of pollutants in animals and in plants/fungi, respectively. It is noteworthy that many of the chemicals represented are pesticides. Pesticides are designed to be toxic to target species. On the other hand, manufacturers seek to minimize toxicity to humans, beneficial organisms and, more generally, nontarget species. Selective toxicity is an important issue. Regardful of the potential risks associated with the release of bioactive compounds into the environment, regulatory authorities usually require evidence of the mode of toxic action before pesticides can be marketed. Other industrial chemicals are not subject to such strict regulatory requirements, and their mode of action is frequently unknown.

As U.S. EPA continues to revise the regulatory program for incinerators in order to adequately protect human health and the environment, the omnibus permitting authority, site-specific risk assessments, and public participation issues have received greater attention. The following discusses both issues in greater detail. 

Land application of wastes is becoming more widespread as regulatory authorities move to protect water quality by restricting waste disposal into rivers, lakes and the marine environment. It is not clear, however, that soil is in fact an appropriate dumping ground for all our wastes. 

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