Common use of Good Laboratory Practices Clause in Contracts

Good Laboratory Practices. “Good Laboratory Practices” shall mean FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of nonclinical studies as set forth in 21 C.F.R. Part 58 and applicable guidance documents, as well as similar applicable standards in foreign jurisdictions.

Good Laboratory Practices. “Good Laboratory Practices” shall mean the FDA’s standards for the designconducting non-clinical laboratory studies, conduct, performance, monitoring, auditing, recording, analysis, and reporting of nonclinical studies as set forth including those standards contained in 21 C.F.R. Part 58 58, and all comparable standards of the EMA and any other applicable guidance documentsGovernmental Body or other entity with authority over the safety, as well as similar applicable standards in foreign jurisdictionsefficacy, approval, development, testing, labeling, manufacture, storage, marketing, promotion, sale, commercialization, shipment, import, export or distribution of pharmaceutical products.

Good Laboratory Practices. “Good Laboratory Practices” shall mean the FDA’s standards for the designconducting non-clinical laboratory studies, conduct, performance, monitoring, auditing, recording, analysis, and reporting of nonclinical studies as set forth including those standards contained in 21 C.F.R. Part 58 58, and all comparable standards of the EMA and any other applicable guidance documents, as well as similar applicable standards in foreign jurisdictionsSpecified Governmental Body.

Good Laboratory Practices. “Good Laboratory Practices” shall mean means the FDA’s standards for the designconducting non-clinical laboratory studies, conduct, performance, monitoring, auditing, recording, analysis, and reporting of nonclinical studies as set forth including those standards contained in 21 C.F.R. Part 58 58, and all comparable standards of the EMA and any other applicable guidance documentsGovernmental Body or other entity with authority over the safety, as well as similar applicable standards in foreign jurisdictionsefficacy, approval, development, testing, labeling, manufacture, storage, marketing, promotion, sale, commercialization, shipment, import, export or distribution of pharmaceutical products.

Good Laboratory Practices. “Good Laboratory Practices” shall mean means the FDA’s standards for the designconducting nonclinical laboratory studies, conduct, performance, monitoring, auditing, recording, analysis, and reporting of nonclinical studies as set forth including those standards contained in 21 C.F.R. Part 58 58, and all comparable standards of the EMA and any other applicable guidance documents, as well as similar applicable standards in foreign jurisdictionsSpecified Governmental Body.