The National Medical Products Administration (NMPA) of China is currently soliciting public feedback on the revised draft proposal for the annex amendment of the Good Manufacturing Practice (GMP) standards for blood products. This updated version introduces new requirements focusing on information technology and visualization in the manufacturing and testing processes of blood products, marking a departure from the 2010 revision of GMP.
Specifically, Article 25 in the Raw Material Plasma section now includes a mandate for “using information technology to accurately record the collection, storage, transportation, and inspection data of raw material plasma.” Additionally, a new Article 35 has been introduced in the Production and Quality Management section, stating that “enterprises should employ information technology to accurately document all data generated during production and inspection, ensuring ongoing compliance with legal standards.” It further emphasizes the need for visual monitoring measures in key production and inspection processes based on quality risk assessments. For manual operations, including manual actions, observations, and recordings, the data must be promptly entered into relevant information systems or transformed into electronic data to ensure the authenticity, completeness, and traceability of the data.- Flcube.com
