GMP MANUFACTURING

GLP→

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.

Providing GLP and GMP manufacturing services allows LATITUDE to offer our clients full product development support, from formulation development through manufacture of clinical trial material and GMP release and stability testing.

GMP→

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 Pharmaceuticals provides clients with GLP- and GMP-compliant manufacturing and analytical testing services (including method development and validation) to fulfill the requirements of regulatory agencies around the world for IND-enabling studies (e.g., GLP Tox), as well as 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, package and label a variety of dosage forms to support GLP toxicology (GLP-tox) studies and early-stage human clinical trials, including:

  • sterile injectables

    • sterile fill/finish, including lyophilization

    • vials, prefilled syringes, IV bags

  • ophthalmic drugs

    • eye dropper bottles

  • oral liquid dosage

  • oral solid dosage

  • topical formulations

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 been approved for pharmaceutical drug manufacture by the State of California Department of Public Health (Food and Drug Branch).

LATITUDE’s GLP/GMP Capabilities →

(including for complex liquid formulations)