The COVID -19 crisis has been the acid test for many businesses, including pharmaceutical and biotech manufacturers. Those who had invested in their resilience have gained a competitive advantage over organizations that are less prepared for unforeseen events.
Resilience understood as “strategic resilience”: the capacity to anticipate and adjust, to react quickly to changing conditions, to turn threats into opportunities and to seize those opportunities in due time.
Pharmaceutical and biotech manufacturers who invest in their resilience gain a competitive advantage over organizations that are less prepared for unforeseen events.
In this uncertain scenario Manufacturing Execution System (MES) prove to be a true game-changer as it provides the basis for automated real-time production and quality control by digitising production processes that allow fast and informed decision-making – ensuring GMP-compliant production processes from clinical trial to commercial manufacturing.
There are 7 good reasons for MES that can help manufacturers respond to their challenges and take the path towards Pharma 4.0.
1. Allow remote operations
The online services offered by an MES allow a large part of the workforce to work remotely and access data from home. For example, Master Batch Records (MBRs) can be designed, reviewed, tested, verified and approved in a completely remote way. Electronic equipment logbooks are accessible from home.
In the case of self-inspections or health authority audits, batch records can be quickly accessed in electronic format and presented remotely. It is no longer necessary to waste time searching for indexed paper records in physical archives to find specific documents that inspectors ask for.
2. MES as a service: remote delivery of manufacturing IT
Rather than setting up MES & Business Continuity infrastructure locally, pharma and biotech manufacturers can turn this time-consuming responsibility over to the remote MES supplier. The production data is stored in a dedicated data centre.
An ideal solution for those companies that are unable to implement a MES – for instance, because access to the facility is limited or because they don’t have any production-grade IT infrastructure in place.
3. Remote visibility to processes
With paper-based processes, it is not possible to monitor workflows, detect errors, integrate and share information in real-time and ensure data integrity at all times. This makes it difficult to react promptly and appropriately in a crisis situation when certain information is needed quickly and access to premises may be hindered. In an MES, critical batch status information is available anytime and anywhere with just one click.
4. Increase process efficiency and flexibility
MES increase process flexibility in various ways, for example with regard to supply chains, process design, scheduling and execution, resource management and allocation, or workforce mobility. At the same time, MES reduce dependencies by making process knowledge available to everyone. Operators or quality professionals can use online repositories of all relevant data, e. g., for batch record release.
5. Speed up time to market
MES shorten time to market by providing end-to-end, integrated knowledge management around the control strategy, starting in-process development for the drug substance and the drug product via clinical trials up to technology transfer and commercialization. No knowledge from earlier stages will be lost because the manufacturing control strategy is preserved in the electronic MBRs which are developed step-by-step to commercial maturity.
6. Safeguard regulatory & patient quality expectations
Especially when it is necessary to react quickly to increased demand, effective quality assurance is essential. Insufficient quality increases production costs and prevents on-time delivery. The MES helps to ensure compliance with the International Council of Harmonization (ICH) quality guidelines, FDA, EMA and cGMP quality assurance regulations by guiding the operator through approved process steps. It thus reduces repetitive human errors and provides real-time control of Critical Process Parameters (CPPs) by accurate decision-making based on precisely captured shop floor data to control the Critical Quality Attributes (CQAs) during quality-critical process execution.
7. Digitize manufacturing processes
MES enable the digitization of production-related processes, thus greatly increasing process transparency, flexibility and speed. Processes depending on paperwork require the physical presence of documents, available storage capacities, record management systems and people who handle them. Moreover, they have a high data integrity risk. This slows down processes, increases the probability of human error or total loss of a batch record, and impairs production quality and compliance. Digital processes, by contrast, are not only faster, but they can also be monitored and controlled remotely and much more efficiently.
In summary, keeping MES technology updated and supported, will not only mean that projects are more cost-effective, as the lifecycle is extended, it will also ensure that operations run smoothly, getting the maximum output from manufacturers’ investments.
How an MES supports your business continuity, Werum White Paper – Pharma software. Körber AG
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David is an experienced director in the MES area with a proven track record working in the pharmaceutical industry. He is skilled in people management, business process, IT service management, IT strategy, project portfolio management and outsourcing. At ProjectBinder, David heads the development of the MES/Analytics and Serialisation Team.