Good Laboratory Practice requirements

Much of what is done (and how it is done) in repeat-dose studies is a response to a number of regulations. Three of these have very broad impact. These are the Good Laboratory Practices requirements, Animal Welfare Act requirements, and regulatory requirements that actually govern study design. 

The 1989 OECD council decision Recommendation on Comphance with Good Laboratory Practice requires the establishment of national comphance monitoring program based on laboratory inspections and study audits and recommends the use of the guides for comphance monitoring procedures for good laboratory practice and the guidance for the conduct of laboratory inspections and study audits. 

In a modem laboratory the general guidehnes encompassed in good laboratory practices require careful interpretation when apphed to a laboratory that relies heavily on automated documentation, data files, and electronic signatures 21 CFR part 11 provides that interpretation. 

The system must provide the ability to print various inventory, sample, and pre- and post-dispensing labels. All labels should include a bar code and printed text with the pertinent batch and/or lot information. Labels must comply with GMP-GLP (good laboratory practices) requirements to meet the needs of both laboratories and clinical manufacturing. Labels should be available in multiple sizes to accommodate laboratory sample containers as well as production drums. 

Good laboratory practices require that management establish a QAU to monitor each study to assure conformance with the regulations. The GLPs also state that the QAU must be entirely separate from and independent of personnel engaged in the direction and conduct of the study. 

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