Vaccine factories need informatization and automation
Recently, the accident at the Emergent Bio Solutions plant has spread in the industry.
In addition to watching this incident, what inspiration can we have? I believe you, like the author, have many questions to ask. Why is the SOP that complies with GMP regulations not implemented? Why is there no timely record at the scene? Is the training of employees too formal? Has the manual handover created any confusion? Do all the abnormalities, CAPAs, and deviations get enough attention from the QA staff?
The author believes that apart from strengthening information and automation, we seem to have no better way.
1. Why is the SOP that complies with GMP regulations not implemented? Why is there no timely record at the scene? The role of the information management system is to ensure that the execution of the process must comply with the specifications. But most of the system's operation is outside the B-level zone, if it is a fully automatic process, there is no problem. Manual operation and manual handover make it impossible to realize real-time recording. 2. Is the training of employees too formal? There are also such problems in China. According to the book, there are few opportunities for actual operation. After all, actual operation has a cost. If we use AR and VR technology for training, we may also provide good training effects and enhance quality.
3. Has manual handover caused confusion? In some processes that require manual handover, automatic equipment is introduced. Reduce the possibility of human error. 4. Do all abnormalities, CAPA, and deviations get enough attention from QA personnel? It is reflected in the information system in time, and the information system can provide early warning. Including but not limited to system reminders, sound alarms, phone calls, text messages, and WeChat.
We believe that in the fields of vaccine biopharmaceutical production, cell and gene therapy, for the future trend, the whole production process of the enterprise adopts computerized system management, data recording and analysis of the whole life cycle of the product, to ensure the safety and control of the product , Traceability is a key part of ensuring product quality, and it is also the general trend of industry development.