The Regulatory Environment

The regulatory environment applicable to electronic systems, such as an EDMS, became clearer with the publication of the U.S. Food and Drug 

Administration (FDA) electronic records and electronic signatures rule, 21 CFR 11 [3]. Although only applicable to systems subject to inspection by the FDA, it gives guidance on what should be considered when developing and implementing an EDMS. The details of this rule are covered in Chapter 16 of this book. 

A cGMP analytical laboratory typical operates under a set of SOPs governing the conduct of routine procedures, such as  

Defining user requirements and setting functional and performance specification 

Equipment testing to verify system is operating according to predefined functional and performance specification 

Verification that system is consistently operating as intended for the selected application (system suitability testing) 

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James L. Regens, "The Regulatory Environment for Coal Development," in Costs of Coal Pollution Abatement Results of an International Symposium. Paris Organisation for Economic Cooperation and Development, 1983. 

SFE instrument development has greatly been stimulated by the desire of the Environmental Protection Agency (EPA) to replace many of their traditional liquid-solvent extraction methods by SFE with carbon dioxide. In the regulatory environment, EPA and FDA approved SFE and SFC applications are now becoming available. Yet, further development requires interlaboratory validation of methods. Several reviews describe analytical SFE applied to polymer additives [89,92,324]. 

The latest developments in the regulatory environment related to plasticised or flexible PVC used in medical devices, alternatives to conventional PVC plasticisers and alternatives to PVC as the polymeric material are described. An assessment of strengths and weaknesses of the options is also provided. 3 refs. 

The regulatory environment is changing in Victoria with introduction from March 2000 of the Major Hazard Facilities Regulations, based on the Seveso II Directives. These are expected to flow on to the other states considered in this chapter. The key requirement of these regulations is the preparation of a Safety Case, which must demonstrate, among other requirements, that the risk from the new plant has been reduced to as low as is reasonably practicable - ALARP . The plants will incorporate a number of design features intended to reduce the risk from the facilities and demonstrate compliance with this criterion. 

Process monitoring and control of API production, sans the regulatory environment, is analogous to that within the chemical industry. Since the early 1990s, numerous papers have been published noting on-line specnoscopic techniques as applied to API reaction monitoring. A representation of some of these on-line specnoscopic reaction monitoring techniques will be provided herein with additional information discussed in Chapter 15. 

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... 

Despite widespread agreement that the current system is woefully inadequate in its ability to review new excipients, the regulation of excipients remains mired in the traditional system that relies upon approval of excipients only as components of a drug product, with no true independent review. In this chapter, we discuss the existing regulatory process for excipient review, as well as some potential alternatives to the existing process, some of which have been attempted, without much success, in the past. This article focuses on the regulatory environment in the United States. Where the discussion is applicable to other countries, it will be specifically mentioned in the text. 

Process spectroscopy is, almost by definition, done to measure and control an industrial process. Almost all of the work is driven by business needs, such as improving profits or product quality. In competitive business environments, firms preserve every advantage possible by protecting valuable measurement systems as trade secrets. Thus, firms are often reluctant to reveal process spectroscopy applications, whether successful or not. Notable exceptions to this include the desire for positive publicity around improved safety or to direct the regulatory environment. Often, companies will patent the work and will not publish in a scientific journal until after the patent is filed, if ever. Many applications, such as the classic titanium oxide-monitoring paper, are revealed only years after implementation. As a consequence, the current state of the art in the literature is quite likely far out of date. 

The regulatory environment will continue to change. As of this writing, the key regulatory instrument is OSHA 29 CFR 1910.119, Process Safety Management of Highly Hazardous Chemicals, which pertains to process safety management within plants in which certain chemicals are present. 

The relevance and importance of the regulatory environment cannot be overemphasized. This overview of the roles and responsibilities of both the sponsor and the regulatory agency serves to illustrate the interaction between the two, both before and after a drug is approved for marketing. As well as being experts on... 

The choice of a bioseparation technique will depend on a number of factors, including the initial location of the product inside or outside the cell, as well as the product size, charge, solubility, chemical or physical affinity to other materials, and so on. Economic factors also come into play, including the value of the product, the regulatory environment in which the product is manufactured, and the balance between the capital cost of the bioseparation equipment and the operating cost of running it. 

Commission Communication on Implementing the Lisbon Programme A Strategy for the Simplification of the Regulatory Environment COM(2005)535, 25 Oct. 2005. 

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