How to control the circulation process of pharmaceutical intermediate suppliers?

The circulation control of pharmaceutical intermediate suppliers needs to focus on key aspects such as supplier qualifications, quality acceptance, storage and transportation to ensure compliance with regulatory requirements and quality standards. ‌
Supplier Qualification Review
It is necessary to select suppliers with legal production/operation qualifications, review their qualification documents (such as business license, drug production license, etc.), and regularly review and update them. The intermediate of traditional Chinese medicine decoction pieces must ensure that the supplier has the qualifications for the production or operation of traditional Chinese medicine decoction pieces, and keep relevant qualification documents and purchase receipts. ‌
Quality acceptance management
After arrival, it is necessary to conduct batch by batch acceptance, inspect the appearance, labels, and quality testing, record the drug batch number, production date, supplier information, etc. Intermediate products that implement approval number management need to be recorded with a number. Intermediates that fail the acceptance inspection shall not be stored in the warehouse. ‌
Storage and maintenance
Store according to packaging labels or instructions, regularly monitor temperature and humidity, and manage areas to avoid cross contamination. It is necessary to establish an inventory management system, conduct regular inventory checks, and handle expired or deteriorated intermediates. ‌
transport control
Delivery vehicles must comply with drug transportation standards, maintain stable temperature and humidity during transportation, and use temperature control equipment if necessary. Record the delivery trajectory and delivery information to ensure traceability. ‌
Regulatory compliance
It is necessary to comply with regulations such as the "Measures for Quality Supervision and Management of Drug Operation and Use", clarify that the legal representative or main person in charge of the enterprise bears the main responsibility for quality, establish a quality traceability system, and strengthen logistics standards and risk control.