How can biopharmaceutical companies ensure that their purified water systems can smoothly pass GMP, FDA, and other certifications?

Qiqin follows the latest Chinese, American, and European pharmacopoeia standards from the design source, and the system fully complies with GMP, FDA certification requirements, and ISPE/FDA guidelines. We provide full process validation services, including URS, DQ, FAT, SAT, IQ, OQ, PQ and other complete validation documents. All functional units have undergone strict confirmation. At present, we have assisted multiple listed pharmaceutical companies such as Shengxiang Biotechnology in obtaining domestic and international certifications in one go, with a stable water resistivity of 18.25M Ω. cm, TOC<5ppb, and microorganisms<0.1cfu/ml, which are all superior to pharmacopoeia standards.