The Quality Control (QC) department at LuinaBio is responsible for sampling and testing a wide range of materials including raw materials, in-process samples, drug substance samples, drug product samples, stability samples and environmental monitoring samples. LuinaBio’s QC staff is trained in state-of-the-art analytical techniques. The instruments LuinaBio employs are validated according to current guidelines (including ICH) and the methods of analysis meet all international requirements and will be qualified / validated as appropriate for the specific product development stage.
LuinaBio’s QC department perform two distinct functions, being the Analytical (Bio)chemistry analysis and the Transfer and Validation of analytical methods. Analysis includes raw material testing, in-process/intermediate control testing, bulk drug substance testing, drug product testing and stability testing. Method Transfer and Validation activities ensures efficient transfer of analytical methods and set-up of new methods to support our client production processes.