Drug quality is closely related to patient safety and health. As a pioneer in innovative drug production in China, Chipscreen’s Quality Management Department has established a product lifecycle management system based on the concept of Quality-by-Design (QbD) and risk management principles, and conforming to domestic and international guidelines as well as NMPA, ICH, FDA, and WHO regulations. The system encompasses supervision of the quality systems operated by each member of the Chipscreen Group, quality management of the life cycle of the MAH product chain, and joint management of product lifecycles by each quality unit, ensuring product quality across the entire Group, and keeping patients safe.
Patient safety is our top priority. In accordance with the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the regulations of National Medical Product Administration (NMPA), and with reference to the drug alert system maintained by international pharmaceutical companies, Chipscreen Biosciences has created an integrated multi-division pharmacovigilance system administered by a dedicated Pharmacovigilance Department, which is responsible for supervision, evaluation and management of drug safety throughout the entire product life cycle, from the first human trial to post-marketing safety assurance.
To ensure drug safety, the Pharmacovigilance Department is also responsible for communications with regulatory authorities and filing reports as required by regulations. We have also instigated a series of standard operating procedures (SOPs) and regular employee training, requiring any issues related to drug safety or product quality to be reported immediately.