Regulatory requirements listed

The testing of chemicals/wastes to establish the nature of their hazard capacity/threat in accordance with regulatory requirements falls into four categories (1) reactivity, (2) ignitability/flammability, (3) corrosivity, and (4) EP toxicity. Commercial chemical products, specific wastes, and wastes from specific processes may be listed as hazardous wastes because they are known to present toxic hazards in the manner of the tests above and/or are known to present serious toxic hazards to mammals/humans. In the discussion to follow, various chemical groups will be examined primarily in the context of reactivity, ignitability, and corrosivity. 

Other regulatory requirements of a DFR smdy and important factors that need to be considered to design a DFR study are listed in Section 2. 

Voluntary industry initiatives supplement regulatory requirements. The chemical industry has voluntarily undertaken several initiatives to provide guidance on chemical process safety, including processes involving reactive hazards. However, at present, no industry initiatives list specific codes or requirements for reactive hazard management. 

The concept of a safety case comes from the requirements of the European Union/European Community (EU/EC) Seveso Directive (82/501/EC) and, in particular, regulations that the United Kingdom and other member states used to implement that directive. United Kingdom regulations (Control of Industrial Major Accident Hazards [CIMAH], 1984 replaced by Control of Major Accident Hazards Involving Dangerous Substances [COMAH] in 1999) require that major hazardous facilities produce a safety report or safety case.64 The requirement for a safety case is initiated by a list of chemicals and a class of flammables. Like the hazard analysis approach (Section 8.1.2), experts identify the reactive hazards of the process if analysis shows that the proposed process is safe, it may be excluded from additional regulatory requirements. 

If the plant used or produced listed chemicals at levels greater than the TQ level listed in PSM and RMP regulations, plant management would be required to comply with all regulatory requirements as related in the regulations. 

List the common excipients used and also the regulatory requirements for approving excipients. 

This section lists sources used to develop the incident investigation management system corporate guidance, regulatory requirements, and other reference materials such as this hook. 

Identification of exceptional regulatory requirements (SARA .311/ .313 lists status FDA controlled substance list NORM or other radiation issues, chemical-specific registration or license requirements)... 

While there is some overlap among these, the regulatory requirements are easier to evaluate when taken in these separate parts. Break up your evaluation of any new or existing system into these three areas. Create a generic list of questions or preferred features based on these three areas, keyed to specific sections in the regulation, then apply these questions or research these features for the systems in question. Remember that not all electronic records require signatures, so the electronic signature controls may not even be relevant to the system under review. 

Harmonization of regulatory requirements was pioneered by the European Community (now the European Union) in the 1980s, as it moved towards the development of a single market for pharmaceuticals. The success achieved in Europe demonstrated that harmonization was feasible. The harmonization process was then extended to include Japan and the United States. The ICH was formed from a government body and an industry association from each of these regions. These bodies and associations as listed by Molzon (2006) are ... 

Bioburden testing is required for biologies used in pivotal preclinical studies to support clinical development and registration. Endotoxin levels are the primary concern in this regard. There are several major regulatory documents listed below (taken from Associates of Cape Cod Inc. Web site http //www. acciusa.com/) that describe how drugs, devices, dialysate, water, and other substances are to be tested for endotoxin. 

The appended tables in Annex A summarize the main regulatory requirements for pharmaceuticals for man and animals and may answer many initial questions. Those who need more detailed information should consult the information sources and references listed in Annex B to this chapter. 

Electronic records can be identified by searching regulatory requirements for the key words record and document. This appendix is based on the U.S. Code of Federal Regulations and EU Directives, and is not intended to be exhaustive. More definitive listings are expected to be published by industry groups such as ISPE/GAMR... 

The requirements listed above can be considered the prime reasons for including excipients in dosage forms since they relate directly to product performance. Issues such as regulatory acceptability, environmental effects and impact on cost of the product are also important selection criteria. 

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