GMP Drug Manufacture and GMP 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 (including for complex liquid formulations)
LATITUDE Pharmaceuticals provides clients with GLP- and GMP-compliant manufacturing and analytical testing services to fulfill the requirements of regulatory agencies around the world for the supply of Phase 1 and Phase 2 clinical trial materials (CTM, or clinical trial batch manufacture).
Operating within a centralized Quality Assurance System managed by our experienced and dedicated Quality Assurance Department, LATITUDE can GLP or GMP manufacture a variety of dosage forms such as sterile injectable or ophthalmic drugs, as well as non-sterile oral or topical formulations, to support GLP toxicology (GLP-tox) studies and early-stage human clinical trials. LATITUDE is particularly proficient in the manufacture of complex liquid formulations such as emulsions (e.g., nanoemulsion), 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 a GMP aseptic filling suite for sterile fill finish with an ISO Class 5 BSC and an ISO Class 7 background, as recommend by the FDA guidance for aseptic processing. LATITUDE has also been approved for pharmaceutical drug manufacture by the State of California Department of Public Health (Food and Drug Branch).
The addition of GLP and GMP services will allow LATITUDE to bring another level of offerings to our clients, providing clients with product development support from formulation development through manufacture of clinical trial material and GMP release testing.
Contact LATITUDE for more information.