Personnel Elements of Good Laboratory Practices
Abstract
CLINICAL TOXICOLOGY, 15( 5), pp. 527-538 (1979) Personnel Elements of Good Laboratory Practices HOWARD THOMPSON Baxter-Travenol Laboratories Deerfield, Illinois 60015 The proposed Good Laboratory Practices require that we manage our human resources effectively in orde r that well-qualified personnel a r e carrying out effective procedures which will result in valid study results. The personnel requirements are rather specifically stated in Subpart B, Organization and Personnel, of the proposed Good Laboratory Practice regulation. These requirements a r e very similar to those specified in the proposed Good Manufacturing Practice regulation for drugs, outlined in Subpart B, Organization and Personnel (Fig. 1 . ) At Travenol Labs we have been working for some time with these G M P regulations and have implemented a GMP training system which we feel meets these requirements. We feel much of the training system we have developed for G M P can be related to the GLP requirements. It is from this point of view that I am speaking with you today regarding GLP personnel requirements. There are five personnel system elements we should examine which relate to developing qualified personnel and safety and health issues. These five elements include: 1 Identifying qualified