DETAILS DESCRIPTION
Drug Product
- Position :
Our GMP Drug Products Pilot Plant can meet the production and storage needs of Phase I and Phase II clinical samples. With advanced equipment configurations and comprehensive functionalities, we can flexibly produce various processes with production batches ranging from 1 kilogram to 30 kilograms. Our state-of-the-art laboratory equipment includes spray dryers, wet granulators, dry granulators, pulverizers, granulators, multifunctional fluidized beds, mixers, tablet presses, capsule filling machines, high-efficiency coating machines, blister packaging machines, and more.
Our GMP preparation analysis laboratory has established a complete quality management system, which can not only meet the QC inspection and release work related to GMP workshops, but also meet the long-term stability and accelerated stability under GMP conditions for the consistency evaluation of generic drugs.The system covers institutions and personnel, laboratories and equipment, materials, verification, documents and records, inspection, calibration, quality assurance, etc. It specifies the responsibilities of departments and corresponding management personnel, and establishes personnel training and experimental record filling, auditing, documentation, change control, deviation and OOS/OOT processing procedures, CAPA management, reference preparation and control substance management, chromatography data processing, software authority management and other systems.
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