The FDF facility is located in Zone B of HUAPONT Pharmaceutical Industry Park， neighboring theR&D center. With a total area of58100 m2, it includes production area, warehouse, QA, QC and other buildings.
The quality management system ofFDF facility is set up based on EU GMP and FDA cGMP, which aims at strictly in-process control so as to ensure products quality, patients’ safety and drug efficacy.
PERSONNEL AND EQUIPMENT
More than 270 employees with qualification certificate are working in the facility; nearly half of them are from QC/QA/EHS departments which constitutes a strong quality management system supporting the running of facility.
With the intensive safe and effective requirement forhumanmedicine, the integrated and advanced analytical equipments and production equipments are installed. Moreover, the PMES/ LIMS management systems are introduced into the management of facility.
With the development of twenty years, seven production lines includingoral solid, oral solution, external preparation, injection and lyophilized are established. The annual manufacturing capacity is described as below:
|Dosage Forms||Capacity (Million unit/year)|
|Cream/ Ointment/ Gel/ Lotion||60||Tube|
With the extension of domestic market and overseas market development, the manufacturing capacity and manufacturing environment need to match the higher requirements. HUAPONTPHARMhas started the construction of new FDF manufacturing sitewith a targetto increase the manufacturing capacity and compliance with the GMP of CFDA, FDA, EU and PIC/S.
the overall planning for new FDF manufacturing sitegoing to put in use is that building construction will be completed in end of 2017; production lines and premises will be installed before June 2018; Corresponding inspections such as GMP/EHS will be conducted after then; Eventually the new FDF manufacturing site is planned to put in use in 2019. Allproducts will be transferred to new FDF manufacturing site, and the manufacturing capacity will increase 4~5 times comparing with the current level.