From 25 to 28 December 2019, workshop 801 in Qidu Pharma, which produces PP ampoule, was under on-site inspection from GMP experts of Shandong Drug Administration. The panel of experts checked the institutions and staff, equipments, file management, production technology, quality control and assurance carefully and highly appreciated the new concept for process design and the intelligent control system. They agreed that the workshop had no serious or major defects and complied with current standards and passed GMP on-site inspection.

The newly-built workshop producing PP ampoule covers an area of more than 7,000 square meters and has design capacity for 1 billion needles, which is the latest generation of smart workshop enjoying intelligence, informationization and automatization. Process design adopts the concept of zoning management to avoid contamination and crossed contamination. The material storage area is divided from production area. The access for people is separate from the access for materials. The power system and production system of BFS equipment are independent. The production management adopts intelligent control technology. Blowing, filling and sealing are continuous. The workshop of filling is fully automated and the batching system can realize one-key operation. The SCADA data collection system can realize visual and paperless production. The MES manufacturing execution system can cover all production chains. Compared with traditional glass ampoule, PP ampoule is easy to open and has no debris and avoids scratching and contamination. The time for key production process is short and it’s less possible to contaminate needles. The product quality is more safe and reliable.

Qidu Pharma’s smart workshop of PP ampoule aims to build the top brand about PP ampoule series and become the benchmarking smart workshop. It can consolidate and broaden the advantages of the injection sector and satisfy various market demands better. It is significant to change and optimize product mix and accelerate the conversion of old and new kinetic energy and catch and surpass top domestic management.