Regulatory requirements recommendations

U.S. EPA s recommendations regarding stack emission tests, which may be performed at hazardous waste combustion facilities for the purpose of supporting MACT standards and multipathway, site-specific risk assessments, where such a risk assessment has been determined to be necessary by the permit authority, can be found in the U.S. EPA document on Risk Burn Guidance for Hazardous Waste Combustion Facilities.32 The applicability of the new standards has been demonstrated in the management of hazardous waste incinerators, whose performance was shown to clearly surpass the regulatory requirements in all tested areas.33... 

Established Practices Codes, standards, regulatory requirements, industry guidelines, recommended practices, and supplier specifications have all developed over the years to embody the collective experience of industry and its stakeholders in the safe handling of specific materials. These should be the engineer s first resource in seeking to design a new facility. 

Globalization of fhe pharmaceufical industry has created the need to harmonize the recommendations for fhe developmenf of new pharmaceuticals as well as the regulatory requirements. To address this need, in 1990, experts from the pharmaceutical industry and regulators from fhe United States, Europe, and Japan joined together to establish the ICFl... 

Level 2 sampling programs are directed toward a more detailed representation of stream composition. They are not as inclusive as Level 1, in that resources are expended to improve information only on streams of a critical nature and on compound classes defined as present by Level 1 analysis. Level 2 sampling is optimized for specific compounds or classes of compounds contained in the streams sampled. Level 2 also provides a more quantitative description of the concentrations and mass flow rates of the various substances in the stream. Further, recommended procedures for compliance testing should be introduced into the program to ensure that the data acquired by the procedures selected for Level 2 sampling can be correlated with regulatory requirements. 

During Level 3 programs, it is anticipated that Level 2 sampling will be conducted at predetermined intervals to check the limited Level 3 information. Further, recommended procedures for compliance testing should continue to be applied in the program to ensure that data correlations with regulatory requirements can be met on a long-term basis. 

Sertindole is one of the newer antipsychotic medications available. It is classified chemically as a phenylindole derivative and has activity at dopamine and serotonin receptors. It is not associated with sedative effects. Sertindole was voluntarily withdrawn from the market late 1998 due to concerns over the risk of cardiac arrhythmia s. The European Commission recommended lifting the marketing restrictions on sertindole in 2005 with a regulatory requirement of ECG monitoring. 

Global Harmonization Task Force (GHTF), which was formed to harmonize regulatory requirements for the medical device may recommend referring to ISO 10013 for general guidance on the content of a quality manual. 

IAEA has been developing recommendations on classification of radioactive waste and principles for exempting radioactive waste from regulatory requirements for radioactive material for more than 30 y. This Section briefly reviews these developments. 

Significance of Guidance. This document represents recommendations from the GHTF study groups and does not describe regulatory requirements. The FDA is making this document available so that industry and other members of the public may express their views and opinions. 

Because the framework of every clinical research study relies on a number of interdependent disciplines, the development of a clinical study protocol is ideally a multidisciplinary task. Teamwork, coordinated by one experienced person in clinical research with good knowledge of the regulatory requirements for new drug development, is essential. The protocol design team should also include input, recommendations, and review by the following ... 

Recommendations would provide a method for checking products marketed in the EU - whether produced in the EU or imported into the EU - including articles. This reinforces the principle (and World Trade Organisation (WTO) requirements) that imports should face the same regulatory requirements as products produced in Europe. A company placing a product on the EU market for... 

You write to ask me for my opinion of XXXX, who has applied for a position in your department. I cannot recommend him too highly, nor say enough good things about him. The validation he conducts is the sort of work you don t expect to see nowadays. His documentation clearly demonstrates his complete capabilities. His understanding and appreciation of regulatory requirements will surprise you. 

The FDA excuses electronic records from 21 CFR Part 11 where they are printed and it is the printed copy that is used rather than the electronic version. The electronic record in these circumstances is considered incidental. The FDA will, however, challenge how such printed copies are used to determine whether in practice there is still a dependency on the electronic version. It is recommended that pharmaceutical and healthcare companies document their use of electronic and printed copies within SOPs. Printed copies must not be taken in an effort to side-step regulatory requirements. 

Many of the recommendations of the ICRP and other radiation protection groups regarding radiation exposure have been incorporated into regulatory requirements by various countries. For the U.S. Department of Energy facilities, radiation exposure limits are found in Title 10, Part 835 of the Code of Federal Regulations (10CFR835). Table 3.1 provides a summary of the dose limits for occupational external exposures. 

It is recommended (see Documentary Requirements, Genereil Documentation section) that a photocopy of an outer pack be enclosed in the registration documentation. This greatly assists the registration committee in determining if the submission is in compliance with the Hecilth Authority regulatory requirements. 

---