Manufacturing Facility & Quality System

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Manufacturing Facility

Yiling Pharma has two sites located in Beijing and Shijiazhuang. 6 workshops are under operation. We can produce general OSD, soft capsule, injectable, and high potent OSD. Our technical team drives projects from pre-formulation development to commercial-scale manufacture, and has finished over 30 site transfer projects, 10+ new drug projects of small batches for a clinical trial, and submitted 10 ANDAs to US FDA.

For tablet and capsule, blister packaging and bottle packaging lines are available in our facility. The annual capacity exceeds 6 billion units and batches size range from 2kg to 2500kg. A new finished the drugs production center is setting up, targeting to be one of the largest finished drug production sotes.

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Quality System

Yiling Pharma has established an independent and strict quality management system covering the entire value chain in accordance with cGMP. Yiling Pharma has passed inspections from US FDA, MHRA, TGA, and authorities of Canada, New Zealand.

QA is responsible for the supervision of the quality during production, vendor management, deviation management, and change control to ensure GMP compliance of production. With regard to site-transfer projects, QA is responsible for approval of BMR, BPR, MVP, PKV, HTS, Stability Protocol, and other related documents.

QC is equipped with state-of-the-art instruments. QC is responsible for the establishment of product specification and development, validation, or transfer of the analysis method of raw material, intermediates, and final products in compliance with GMP requirements.

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In 2017,Yiling Pharmaceutical obtained the accreditation certificate from CNAS, with the accreditation scope covering 95 capability parameters in the 4 major testing fields of medicine, food, health food, and environmental monitoring. Such accreditation certificate is internationally mutually recognized by 149 accredited bodies from 129 economies.

CNAS Laboratory issued the test report. Such accreditation has gained recognition in more than 60 countries and regions, including the EU and the Asia-Pacific region, and boasts international credibility.