The quality management system of Huapont Shengchem is established on ICH Q7 and six system theories of FDA, which aims at strictly process control to ensure products quality, patients’ safety and drug efficacy. Huapont Shengchem applies high precision instruments and apparatus as HPLC, GC, IR spectrophotometer, UV spectrophotometer, TGA, ICPE-9820 Plasma Atomic Emission Spectrometer, Mastersizer 3000 Laser Diffraction Particle Size Analyzer, etc.

Comprehensive quality assurance system, precise quality control methods and environment-friendly production plants are the strong guarantee of products’ quality.

In 2007, a production base of API with high-standard hardware facilities which is accordance with cGMP and international requirements were built in Hechuan district, Chongqing. Huapont Shengchem passed GMP inspection of NMPA and had been granted GMP certificate for the first time in 2008.

 

So far, Huapont Shengchem has accepted audit from authorities and customers for over 100 times:

In 2010, 19 products of Huapont Shengchem had been granted GMP certificate.

In 2012 and 2014, Huapont Shengchem passed GMP inspection of New Zealand Authority (Medsafe).

In 2012, 2015 and 2018, Huapont Shengchem passed GMP inspection of US-FDA.

In 2015, Huapont Shengchem passed GMP inspection of US-FDA with 0 deficiency (No FDA 483).

In 2013, 21 products of Huapont Shengchem had been granted national GMP certificate 2010 version, and Huapont Shengchem also passed GMP inspection of Mexican Cofepris.

In 2014, 2 products of Huapont Shengchem had been granted GMP certificate.

In 2015, 1 product of Huapont Shengchem had been granted GMP certificate.

In 2016, 8 products of Huapont Shengchem had been granted written confirmation exported to EU.

In 2017, 4 products of Huapont Shengchem had been granted GMP certificate.

In 2018, 11 products products of Huapont Shengchem had been granted GMP certificate and 17 products passed GMP recertification.

In 2019, 2 products of Huapont Shengchem passed GMP inspection for drug consistency evaluation.

In 2020, 3 products of Huapont Shengchem passed GMP inspection.

In 2021, 5 products of Huapont Shengchem passed GMP inspection.