Qidu Pharmaceutical Passes Inspections by Provincial Drug Regulatory Authorities

In September, Qidu Pharmaceutical successfully passed multiple consecutive inspections by the Shandong Provincial Drug Regulatory Authorities. The production capacity of Qidu’s oral solutions, APIs, injections, and other products has been unlocked, laying a solid foundation for meeting market demand, expanding market share, strengthening its brand influence in the industry, and enhancing overall market competitiveness.

September 7–11: Experts from the Shandong Center for Food and Drug Evaluation & Inspection visited the company for inspections. These included: first, a license change inspection for adding Production Line 15D in Workshop 411 to the oral solution production scope; second, GMP compliance inspections for oral solutions on Production Line 15D in Workshop 411, APIs on Production Line 3F in Workshop 605, and large-volume injections on Production Line 11C in Workshop 305; and third, a production supervision inspection for drugs in the 12th batch of centralized procurement.

September 8–11: Commissioned by the Shandong Center for Food and Drug Evaluation & Inspection, inspection team experts conducted pre-review on-site registration inspections for Fat Emulsion Injection (C14~24) and Loversol Injection, for which the company submitted supplementary applications. They also conducted post-marketing manufacturing site changes  on-site inspections for Glucose Injection and Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets (15 mg/500 mg). Specifically, the manufacturing site for Glucose Injection was expanded to include Production Line 14B in Workshop 211, and the manufacturing site for Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets (15 mg/500 mg) was expanded to include Production Line 11D in Workshop 411.

September 14–18: Commissioned by the Shandong Center for Food and Drug Evaluation & Inspection, two inspection teams of experts conducted GMP compliance inspections on the post-marketing manufacturing site changes and contracted production lines for 7 injectable products in 12 specifications, which are contract manufactured by our company on behalf of Shandong Wego Pharmaceutical Co., Ltd. as the marketing authorization holder.

September 16–18: Experts from theShandong Center for Food and Drug Evaluation & Inspection visited the company for inspections. These included: first, a production license change inspection for the newly added contract manufacturing of Sodium Chloride Injection; second, a production license change inspection for adding the production of a nonsteroidal mineralocorticoid receptor antagonist API on Production Line 4F in Workshop 605; and third, a compliance inspection of the granule production line (including traditional Chinese medicine extraction).

These inspections covered a wide range of areas and were highly professional. During the inspection response process, relevant leaders and staff from quality, production, logistics management, and other functions collaborated with a clear division of labor, worked in an orderly and efficient manner, actively supported the inspections, and delivered a high-quality inspection response. This demonstrated the employees' excellent professional competence and team spirit, and highlighted the company's first-class pharmaceutical production quality management and GMP implementation standards.