The Gansu Medical Products Administration has issued a set of “Measures for the Management of Key Quality and Safety Personnel within Production and Operation Enterprises in Gansu Province (Trial)”. The notice is designed to regulate the key management personnel of drug production and distribution enterprises within the province.
According to the document, key management personnel of pharmaceutical production enterprises, including the enterprise leader, production leader, quality leader, and quality authorized person, must be full-time employees. It is stipulated that the positions of quality leader and production leader cannot be held by the same individual. The document emphasizes that key management personnel should maintain stability and not change positions frequently.
In the event of a change in key management personnel (excluding the person in charge of drug vigilance) of drug production and trading enterprises, companies must apply for registration of the change of drug production license and drug operation license with the provincial drug regulatory bureau, the corresponding city (prefecture), or county (city, district) market supervision bureau within 30 working days from the date of the change. Following the change, the original license will be reissued, with the termination period of the changed license remaining unchanged. These measures will come into effect from the date of issuance and will be valid for a period of 2 years.- Flcube.com
