Good Practice regulations

Bames D, Alford-Stevens A, Bimbaum L, et al. 1991. Toxicity equivalency factors for PCBs Quality assurance Good Practice, Regulation, and Law. 1 70-81. 

The business model described in Figure 2.1 shows the high-level structure of a pharmaceutical business organization. Company policies are set within an environment of the company mission—the purpose for existence, e.g., to research and develop pharmaceutical products, and external influences including legislation and Good Practice regulation. As this model... 

Known impact of Good Practice regulations on business processes and information strategy... 

Laboratories wishing to claim GLP compliance are nonually registered with Competent Authorities who issue statements of compliance following successful periodic inspections of the premises to monitor compliance with the relevant legislation. In the UK compliance with the Good Laboratory Practice Regulations 1999 is audited by the Medicines Control Agency. 

SI 1999/3106 Health and Safety - The Good Laboratory Practice Regulations... 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

Good manulacluring practice regulations In 21 CFR Parts 210.211 or applicable regutalions. Parts 696, arnlfor 620-... 

Status of current good manufacturing practice regulations. 

Good Laboratory Practice Regulations, edited by Allen F. Hirsch... 

Good Laboratory Practice Regulations Second Edition, Revised and Expanded, edited by Sandy Weinberg... 

From 6 April 2005, the Control of Substances Hazardous to Health Regulation 2002 has been significantly updated. There is now a new focus on good practice to help employers prevent their employees health being harmed by workplace chemicals, and a change to the way limits are set for exposure to chemicals in the workplace. An outline of the updated regulations is given. 

FDA (Food and Drug Administration). (1987a). Good Laboratory Practice Regulations Final Rule. 21 CFR Part 58, Federal Register, September 4, 1987. 

Food and Drug Administration (1987). Good Laboratory Practice Regulations Final Rule. 

The GLP Pocket Book the Good Laboratory Practice Regulations 1999 and Guide to UK GLP Regulations 1999, MCA Publications, London, 1999. 

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