GMP Manufacture and Analytical Testing of Drug Product
GLP and GMP Manufacturing and Analytical Testing
Good Laboratory Practice (GLP) is a set of principles and requirements to support nonclinical studies involved in the drug development process. Manufacture and testing under GLP helps satisfy regulatory authorities that information submitted in applications is accurate and can be relied upon for risk and safety assessments.
Good Manufacturing Practice (GMP) is a system for assuring that drug products are consistently produced to set specifications and are tightly controlled by strict quality standards; GMP is primarily concerned with ensuring the safety and efficacy of an individual batch of drug product that will be released for human use.
LATITUDE’s GLP/GMP Capabilities
LATITUDE Pharmaceuticals provides clients with GLP- and GMP-compliant manufacturing and analytical testing services to fulfill the requirements of regulatory agencies around the world.
Operating within a centralized Quality Assurance System managed by our experienced and dedicated Quality Assurance Department, LATITUDE can manufacture a variety of dosage forms such as sterile injectable or ophthalmic drugs as well as non-sterile oral or topical formulations to support early-stage human clinical trials. LATITUDE is particularly proficient in the manufacture of complex formulations such as emulsions, liposomes, nanoparticles and other controlled-release products.
LATITUDE has completed validation activities related to aseptic filling of Phase I clinical pharmaceuticals. With the successful completion of our media fills, we have validated an aseptic filling suite with an ISO Class 5 BSC and a ISO Class 7 background, as recommend by the FDA guidance for aseptic processing. This will allow LATITUDE to bring another level of service to our clients, allowing LATITUDE to support clients’ product development from formulation development through clinical trials.
Contact LATITUDE for more information.