MES for Pharma

Pharmaceutical manufacturers are facing increased pressure to deliver high-quality medicines quickly and efficiently while also complying with regulatory requirements, such as FDA 21 CFR Part 11 and EU Annex 11. Given the continued demand, paper-based manufacturing processes are no longer practical because they are error-prone, bloated with paper documentation and are manual.  These hinder companies from aligning with the FDA’s vision for continuous quality improvement and continuing their ISPE’s (International Society of Pharmaceutical Engineers) Pharma 4.0 journey.

Manufacturing Execution Systems (MES) make paper-based manufacturing a thing of the past for drug manufacturing companies.

With MES, pharma companies can replace their paper-based manufacturing execution processes with smart manufacturing technologies to optimize each operation phase, achieving and promoting manufacturing efficiency, resiliency and operational sustainability to ultimately accelerate drugs to market.

Since process optimization in the pharmaceutical industry is a priority due to today’s increasing volatile and complex environment, MES serves as a valuable investment. 

Values and Benefits of MES for Pharma

MES bridges the gap between the production floor and the enterprise level operation management in drug manufacturing companies. It automatically monitors, manages and synchronizes production processes in real-time with compliance by design. As a result, right-first-time manufacturing is achieved to increase production quality and throughput, mitigate product costs and cost associated to waste.

The Benefits of Manufacturing Execution Systems

There are several main benefits of using MES for pharma manufacturing. A MES: 

• Allows pharma manufacturers to expedite new manufacturing recipe deployments that traditionally require lengths of training and implementation time.
• Seamlessly scales and transfers production and associated recipes, regardless of production complexities, because procedural executions for both legacy and new processes are digitally enforced and tracked, promoting consistency and mitigating errors.
• Enables fast and predictive production decisions with analytics in pharma manufacturing to promote real-time decisions due to shifts in business demands.
• Sustains continuous improvement by capturing skillful knowledge gathering and sharing.
• Empowers operators to perform more value-added work.

FAQs

What is MES?

Manufacturing Execution Systems (MES) are software solutions that ensure quality and efficiency are built into the manufacturing process and are proactively and systematically enforced. They connect multiple sites, production information and integrate easily with equipment and enterprise business applications such as Enterprise Resource Planning systems (ERPs) and Quality Management Systems (QMS). The result is complete real-time visibility, control and manufacturing optimization of production and processes – at a single site or across multiple sites.

What does MES mean in the supply chain?

Manufacturing Execution Systems (MES) track product and order details on the plant floor, collect transactions for reporting to financial and planning systems and electronically dispatch orders and manufacturing instructions to shop floor personnel. They can also leverage smart technology like machine learning in pharma to continuously monitor and act upon KPIs, including machine readiness. The result is better real-time visibility to critical information for better, faster production decisions.

Long adopted in the mining industry, using MES led to terms such as mine optimization and smart mine. The success was recognized in vertical markets such as specialty chemicals and now pharma and was implemented to experience the same success.

What is MES validation?

To ensure the appropriate validation of MES, it is essential to have a well-defined validation strategy that is based on the company’s validation and quality standard operating procedures and further detailed in an approved Quality Assurance Plan (QAP). Good Automated Manufacturing Practice (GAMP® 5) provides a basis for the development of a companywide quality management system that comprehensively addresses requirements for validation, implementation and use of computerized systems.  

For MES, example elements that are considered in a validation or quality assurance plan are system intended uses, roles and responsibilities such as approvals on deliverables, system lifecycle policies, testing and qualification strategy and regulatory compliance that includes electronic documentation such as electronic signatures and batch records (eBR).