Pharmaceutical digital transformation in China: digital quality assurance takes the driver’s seat

[...]to comply with regulatory requirements, the data integrity of a GMP plant should be at a high level to provide foundational assurance to demonstrate that medical products are safe and effective for their intended use [9]. [...]a majority of drug injury events in China were caused by intentional will or technical reasons, suggesting that there are still gaps between the holder's due diligence ability and high regulatory expectations [10]. Since the revised Drug Administration Law was enacted in 2019, the key drug quality responsibilities of MAH have been further clarified but not adequately implemented; one possible reason for this situation could be a lack of technical capability. The difference between digital quality assurance (DQA) and ordinary quality assurance (QA) Information bearing How it is recorded Data volume Timestamp Modifying the mark Review Physical space Search Backing up Review time cost Ordinary QA Paper Manual Fragments Handwritten Sign In person The archive Carrying and reading Photocopying On a monthly basis DQA Electronics Automatic Massive System generated Audit trail Remote tag Machine room or cloud Electronic terminals Copying In seconds Compared with existing digital quality management systems, such as trackwise systems commonly used in the pharmaceutical industry, the scope of DQA is broader and more holistic and intelligent. [...]in consideration of the weak universality and poor compatibility issues, there is still a lack of corresponding standards in this field on, e.g., how to monitor and control mistakes, manipulation and negligence in critical data affecting drug quality, how to focus and refine manufacturing data collection, calculation and output, and how to coordinately and efficiently apply and assess DQA technologies. [...]it is important to establish a consensus on the DQA-related technology used in pharmaceutical manufacturing, both in concept construction and implementation practice.