Drug quality control laboratory is one of the important departments in drug production and control process, one of the important compositions in CGMP regulation is about laboratory quality control and product testing. Austar can provide integrated laboratory solution conforming to Chinese GMP, FDA, EU or WHO standard.
The type of laboratory validation includes physicochemical analysis method validation and verification, analytical instrument verification, microorganism inspection validation, and bioassay method validation.
The analytical instrument and inspection auxiliary equipment is divided into A, B, C three categories according to requirement of USP.
Laboratory validation can be considered from the following three parts:
Austar can provide all-around solution for pharmaceutical product control laboratory from the following aspects: