From July 4th to 6th, in accordance with the requirements of Directive 62 of the European Union for the active substances exported to the EU, the Jiangsu Province Drug Administration Certification and Evaluation Center appointed a three-person inspection team to conduct a GMP on-site compliance inspection of our company's dehydroepiandrosterone product. Changzhou Municipal Market Supervision Administration appointed observers to accompany the inspection throughout the inspection.

According to the requirements of the new GMP and its appendices for API, the inspection team carried out site tour and document review, the inspection covered quality management, organization and personnel, plant and facilities, equipment, materials and products, qualification and validation, document management, production management, quality control and quality assurance, product shipment and recall and self-inspection, etc. , and the focus of the inspection was computerized system, process validation, use of mother liquor and recycled solvents, and air purification system.

After three days of careful and meticulous inspection, the inspection team believes that: our company's organizational structure is sound and technical management personnel are in place; production and inspection facilities meet the needs of product, and production, materials and product management meet the requirements; quality management system including change control, deviation handling, OOS, CAPA, risk management, product annual quality review is established, and trend analysis of some key parameters is performed. Neither critical nor major observations are made during the site inspection.

This is the second GMP site inspection that we have received regarding our company's dehydroepiandrosterone product. It is not only a test to verify that our company's six quality management systems continue to meet the new GMP requirements, but also a preliminary test for preparing to accept the US FDA registration inspection. This inspection has laid a foundation for further expanding our company's dehydroepiandrosterone product's market share in the EU.