API prepared under cGMP guidelines
24 Scientists Trained for GMP
J-STAR is focused on providing high standards in Quality Assurance in every aspect of the cGMP synthesis and manufacturing process. This is achieved through our focus on our quality systems management. Dedicated quality assurance personnel ensure that documentation and records, SOP’s and laboratory controls are maintained. This group is also responsible for reviewing batch record preparation and execution as well as analytical support. Our Quality Assurance team works closely with clients to facilitate site audits, implement special requests and manage any GMP issues that arise during the manufacturing process.
J-STAR has a dedicated team of analytical chemists to ensure that Intermediates and API manufactured materials are properly evaluated and conform to the assigned purity specifications using properly qualified or validated methods. This team has the capability to develop, qualify and validate analytical methods for the following test methods, many of which are performed in our limited access quality control release laboratory:
Obtained by a qualified outside analytical laboratory and reviewed by our QA and QC group:
Qualified stability chambers are available on-site which are operated and maintained under standard ICH conditions of:
We have the ability to identify impurities and degradants that form in the API upon storage using LC/MS and comprehensive NMR techniques. In addition to identifying these degradants, we can then synthesize them to confirm the structure, to provide material for response factor determinations, and for use a reference standard.