By Sandy Weinberg
Fresh adjustments within the interpretation and enforcement of 21 CFR half eleven have shifted the focal point of excellent Laboratory perform (GLP) laws to pay attention to the recognition of digital signatures, the archiving of knowledge, the protection of digital records, and the automation of laboratory techniques. This all-encompassing Fourth variation addresses each severe point of fine Laboratory perform (GLP) rules and demonstrates powerful concepts for implementation in quite a few laboratory settings. This up to date and increased vintage textual content includes new information regarding using 21 CFR half eleven to the laboratory surroundings, GLP documentation platforms, laboratory hazard research, approach validation and inspection, method analytical applied sciences, and value regulate for the prevention of pitfalls and the reassurance of compliance in different examine environments.
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Additional resources for Good Laboratory Practice Regulations, Fourth Edition (Drugs and the Pharmaceutical Sciences)
Laboratory management therefore has considerable latitude to define job qualifications. Any reputable laboratory will find it to be in its own best interest to hire competent individuals and to provide adequate on-the-job training to qualify those individuals to perform their assigned duties. The FDA is not likely to make an issue of employee qualifications unless an inspection reveals an obvious case of employee incompetence. Documentation of employee qualifications should include at a minimum an educational history for each employee, an employee’s employment history to the extent that prior employment has a bearing on the employee’s competence to perform their current job assignment, and a description of any additional on-the-job training provided to the employee.
There are differences in these regulations and guidelines that pose problems for sponsors planning studies to meet the requirements of different agencies or countries (19). As a solution to part of this problem, the FDA has developed memoranda of understanding (MOUs) with Canada (1979), Sweden (1979), Switzerland (1985), France (1986), Italy (1988), Germany (1988), the Netherlands (1988), and the United Kingdom (1988). These MOUs acknowledge mutual recognition of the adequacy of inspectional programs in the participating countries and permit the exchange of data between the countries without need for independent verification by the recipient country.
Good laboratory practice regulations: final rule. Fed Reg 1987; 52:33768 –33782. 17. Environmental Protection Agency. Federal Insecticide, Fungicide and Rodenticide Act (FIFRA): Good laboratory practice standards, proposed rule. Fed Reg 1987; 52:48920 – 48933; Environmental Protection Agency. Toxic Substances Control. Act (TSCA): Good laboratory practice standards, proposed rule. Fed Reg 1987; 52:489933 –48946. 18. Environmental Protection Agency. Toxic substances Control Act (TSCA): Good laboratory practice standards, final rule.