Medicilon has constructed the GMP Drug Products Pilot Plant to meet the rising needs for innovative medicine R&D, production, packaging, inspections and stability tests. We are aiming for qualified CDMO services for clients with requirements for the development of innovative medicine.
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 40 kilograms. Our state-of-the-art laboratory equipment includes hot melt extrusion machines, 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.
In order to maintain project quality and data truthfulness, we have established a complete and meticulous SOP quality system that we adhere to strictly. From project kick-off to results delivery, we control and monitor the entire formulation process. At the same time, Medicilon’s 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.