With steady demand for medicines, and even in the midst of an evolving global health situation, it is still business as usual for drug manufacturers. However, everything is not the same, thanks to social distancing and the lockdown. With thousands of employees working in limited spaces in person dependent operations, social distancing becomes a challenge. Recently, the presence of a few Covid19 infected employees in a life science company led to stringent home quarantine of 1000 employees and their families. In such a scenario, how will businesses continue serving the market demand? Automation and digitalization of drug manufacturing processes now step in as essential armour for drug manufacturers.
A blessing in disguise, there has been a constant automation effort in Quality Control and Quality assurance due to the increased audit observations on quality management and DI. However, manufacturing area has been the least automated and still person dependent. Many applications are available that can support different stages of manufacturing to automate. They can help perform functions without manual presence to a large extent. Reviews and approvals can also be performed remotely. All this facilitates the reduction of number of people working at a plant considerably. With fewer number of people at the plant site, social distancing is possible, thereby reducing the risk of Covid19 type of infectious disease spread. At the same time, it ensures smooth and uninterrupted operation of manufacturing processes.
Electronic batch record management system (eBRM) helps in automation of manufacturing processes. The batch manufacturing record (BMR) is issued and executed online. Instrument/ weighing balances interfacing enable 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) usage of expired materials in production. Training to concerned operator 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.
Quicker audits and regulatory clearance are a desirable change in the audit process which usually take quite a long time. Manufacturing companies which 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.