Automating the Batch Record Management Process
Automation and digitalization of drug manufacturing processes now step in as essential armor for drug manufacturers. Electronic batch record management system (eBRM) helps in the automation of manufacturing processes.
- The batch manufacturing record (BMR) is issued and executed online to manage the entire batch production.
- Instrument/ weighing balances interfacing enables fetching relevant details like weighing and dispensing information directly into the application.
- With SAP/ERP integration, material management is performed online.
- Electronic logbooks (eLog) help in automating all the logbooks, like area clearance logs, equipment logs, and maintenance logs.
- IPQC management automates the in-process quality control measures taken by the drug manufacturers.
Through digitalization and automation of the processes, time consumed in data collection, effort, and human presence can be reduced considerably.
Further, with digitalization and automation of drug manufacturing processes, companies can get it right the first time. As per the “Do it right the first time” concept, automation helps in avoiding transcriptional errors, deviations, changes, etc. IT enablement would greatly help in knowing how the current batch is performing compared to previous batches of the same material, thereby providing an opportunity to increase the process capabilities. It ensures that calibration schedules are met stringently. The system completely prevents (and alerts users of) the usage of expired materials in production. Training to concerned operators is provided on the processes and SOPs from time to time. Methods are followed stringently and are up to date. The system triggers alerts to ensure that different processes are going on smoothly.
Facing Audits
Quicker audits and regulatory clearance are a desirable change in the audit process, which usually take quite a long time. Manufacturing companies that recently received FDA clearance play a pivotal role in the production of some important life-saving drugs and medicines. The clearance is received relatively easily and in short time due to digitalization of manufacturing companies. Companies that automated their processes with applications helped in making them more compliant through built-in controls, and as a result, the audit process became simpler.
Taking a cue from the current situation, Pharma companies should automate and digitalize their manufacturing processes completely. If Pharma companies have not given it a serious thought, now is the time to take some immediate action.
