Government guidance

Despite the obvious answers to the concerns expressed in Government guidance, few companies or health service units appeared to have had the enthusiasm to take on the inevitable obstacles and bureaucracy involved. Few saw the rewards outstripping the effort. 

Identifying and implementing best practice and performance in the organisation s employment sector and other appropriate sectors (e.g. from relevant Government guidance industry advisory committees and trade association guidelines)... 

The CTD format has been incorporated into the E U regulations and is set out in the revised version of Annex I to directive 2001/82/EC, which was published as Commission Directive 2003/63/EC. It is also supported by detailed guidance in the Rules Governing Medicinal Products in the European Union, Volume 2B - Presentation and content of the dossier - CTD2001 edition. The relationship between the CTD format and the previous four-section format that was used in the E U is shown in Table 6.1. 

The Community procedure for establishing MRLs of veterinary medicines in foodstuffs of animal origin is set down in Council Regulation (EEC) No. 2377/90 as amended by Council Regulation (EC) No. 1308/1999. The regulations are supported by detailed guidance contained in The Rules Governing Medicinal Products in the European Union, Volume 8 - Maximum Residue Limits. 

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

United States Environmental Protection Agency, Electronic Submission and Review Pilot Interim Guidance Documents, US Government Printing Office, Washington, DC. Also available on the World Wide Web http //www.epa.gov/oppfeadl/esr pilots.htm. 

Regulatory authorities govern and direct much of the work of the statistical programmer in the pharmaceutical industry. It is important for you to know about the following regulations, guidance, and standards organizations. 

This guidance document governs how electronic files should be sent to the FDA. Currently, the FDA requests that electronic documents be submitted as Portable Document Format (PDF) files. The PDF page should be a standard 8.5" x 11" page with 1" margins and 12-point font. Data sets are currently to be sent to the FDA as SAS XPORT transport format files. In the future it is likely that data sets will be required to be sent as XMF files, probably formatted in the CDISC ODM. 

The National Research Council has recognized the importance of the food protection problem and the need for an organization to provide technical counsel on the utilization of new materials in the production and processing of foods. The desirability of cooperative action by industry, government, and other research organizations in providing the scientific guidance required for the protection of the food supply has been emphasized. 

Source U.S. GPO, Occupational Safety and Health Guidance Manual for Hazardous Waste Site Activities, DHHS-NIOSH-85-115, U.S. Government Printing Office, Washington, DC, October, 1985. With permission. 

U.S. Environmental Protection Agency (USEPA). Implementation guidance for the arsenic rule. U.S. Environmental Protection Agency U.S. Government Printing Office Washington, DC., 2002a. 

This work was carried out with the strategic guidance and financial support of Penn West Energy Trust, AERI (Alberta Energy Research Institute), Western Economic Diversification Canada, Natural Resources Canada, and the Alberta Government. 

In 1985, AIChE established the Center for Chemical Process Safety (CCPS) in response to the Bhopal tragedy. Manufacturers, government, and scientific research groups sponsor CCPS, which has published extensive industry guidance in the area of process safety technology and management. CCPS recently produced a safety alert on reactive hazards, and a more comprehensive product is under development. 

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