Animal testing facilities operation

The purpose of the GLP regulations is to assure the quality and integrity of the data submitted to the FDA in support of the safety of regulated products. To this end, most of the requirements of the proposal would have been considered familiar and reasonable by any conscientious scientist. Protocols and standard operating procedures (SOPs), adequate facilities and equipment, full identification of test substances, proper animal care, equipment maintenance, accurate recording of observations, and accurate reporting of results are... 

Parts 58.41 through 58.51 cover the physical facihties of the laboratory. The inspector must determine whether or not the facilities are of adequate size and design for completed or in-process studies. The physical parameters and systems of the facilities as they are used to accommodate the various operations employed in the GLP studies are examined. Investigators also deal explicitly with the environmental control and monitoring procedures for critical areas, especially the rooms used for animal housing, the test article storage areas, and the laboratory areas in which biohazardous material is handled. The procedures and methods for cleaning equipment and areas critical to study conduct as well as the cur-... 

GMP is probably the most widespread quality system followed across the pharmaceutical industry as a whole. GMP compliance is a requirement within the R D environment for the manufacture and testing of clinical trial materials (both drag product and API) and for commercial manufacture and testing of these materials for human and animal consumption. R D facilities performing these operations may be subject to audit for compliance to GMP commercial facilities will be audited by the appropriate regulatory authority, possibly without prior warning. 

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