Using Pharma 4.0 technologies has many advantages, including improved production and release processes, more reliable production, assurance of better overall control and data integrity, production automation, and a lower risk of falsification and counterfeiting. To obtain these benefits, it is essential to collect a very large amount of data in real time during production. IP-cProtect is salamanderU’s solution for the remote collection and control of production-related data. It includes the voice-controlled eBR SmartReg, which collects data on operations and equipment, and an Environmental Monitoring System (EMS).
IP-cProtect, our project partly sponsored by the European Regional Development Fund, enables you to remotely control your production processes in real time, whether the operations are being performed by you or by Contract Manufacturing Organizations (CMOs).
Take a look at the following diagram to see how the remote control feature of salamanderU’s IP-cProtect solution works.
Click to enlarge
IP-cProtect consists of three levels:
The first level relates to the data collected at the production stage: process and equipment parameters (for example incubators, centrifuges, microscopes, sensors, and scanners) and environmental parameters (such as pressure, temperature and relative humidity).
The second level, located in the cloud, consists of as many software packages as there are production units. Each of these units registers all the data related to production, equipment and environmental monitoring and places them in a local controller for use at the third level.
The third level, called the central controller, is also deployed in the cloud. It consists of a single portal, which brings together all data from all the production units and offers a general dashboard with an overview of the operations being carried out. This portal is a real-time monitoring tool that highlights any alerts and enables you to connect to any production unit to access all the information held there.
You can collect all the production data in real time (which can be numerous if you have several production sites) and compare them with production results (everything is digitized and modelled in the same way). This means you can improve your Master Batch Records very efficiently and deploy these improvements at all the sites at the same time.
Because salamanderU’s voice-controlled eBR SmartReg is part of IP-cProtect, the batch record reviewer and approver no longer have to analyse the complete batch record. So they can focus on potential production-related problems.
By collecting all the production data, wherever they are produced, and analysing them in real time, you can immediately correct any errors that may occur and improve the reliability of your production.
With real-time remote access to all the operational data, equipment parameters and environmental data, you can ensure that your critical process parameters are compliant and that all manufacturing steps are strictly followed for each batch of finished products.
IP-cProtect meets all European and US regulatory requirements: GAMP 5 (Compliant GxP Computerized Systems), PIC/S Guidance PI 011-3 (Good Practices for Computerized Systems in Regulated GxP Environments), EudraLex Volume 4 (Annex 11: Computerized systems), FDA 21 CFR Part 11, FDA Guidance Part 11 (Electronic Records; Electronic Signatures – Scope and Application) and FDA Guidance for Computerized Systems Used in Clinical Investigations.