Modernising Pharma Manufacturing with Co-Innovation: The Yokogawa Way
By- Sajiv Nath, MD, Yokogawa India Ltd
Envision a pharmaceutical plant where people are watchful and attentive as the business responds to changing times quickly and efficiently. As digital transformation ensues to disrupt, transform and reshape industries, we can now picture an operation that delivers consistent production, real-time information and accurately controlled safe processes that comply to the regulatory and demanding requirements of the pharmaceutical industry. Product quality is affected by factors such as fluctuations in the quality of raw materials and the aging of manufacturing facilities. To help address such problems, manufacturers are turning to digital technologies and solutions such as AI, big data, and Industrial Internet of Things (IIoT).
Therefore, the time has come for co-innovating.
We at Yokogawa have identified the value of automation as we have come to recognize that industrial automation is a business tool, not just a control tool, which can help process businesses meet their industrial challenges. It is imperative for pharmaceutical companies to achieve compliance and safety while maintaining cost efficiency, as any deviation in the set standards can lead to jeopardizing the lives of the end users.
Ideally, an intelligent and scalable Plant Information Management System should be at the heart of the system which provides an analysis and reporting application that collects, stores and displays current and historical data from batch production, equipment and recipe viewpoints. This enables production and recipe management, process engineering, quality management and operations staff to easily access batch information for decision support, production planning & scheduling, analysis, process improvement and quality purposes. These are ideal productivity improvement tools that enable users to focus on KPIs (Key Performance Indicators) such as a cycle time and frequency using web-based browsing, analysing and reporting user interface to develop action plans for process improvements. Intelligence and scalability vary from developer to developer, and the user needs to exercise right diligence to select the one suitable for present and future needs.
It is important to achieve net-zero emissions, take a transition to a circular economy and to encourage pharmaceutical companies to operate in a global marketplace. The industry is encouraged to comply with international initiatives such as the PIC/S Good Manufacturing Practice (GMP) Guide and the ICH Guidelines. GMP facilities need to follow established best practices and automated production equipment, and the computer systems are expected to adopt current computerised system validation (CSV) practices such as Good Automated Manufacturing Practice (GAMP). As a company, the goal of Yokogawa is to contribute to society through broad-ranging activities in the areas of measurement, control and information. Individually, we aim to provide citizens with the courage to innovate. Automation of processes and embedding rules help companies in ensuring that the data produced is compliant. It can be thus concluded that automation is the first step towards achieving improvement in compliance from the regulatory point of view. Contribution from Pharma Industry is seeing a high growth rate over the last couple of years. With innovative IIoT solutions, inherent reliability and Quality –hallmark of Yokogawa and synonymous with Pharmaceutical Industries, we are poised for higher growth in this segment.
The automation of data → knowledge → insights is an area of focus in the immediate future. In order to get to this stage of maturity, we find that majority of the organisations the size of Yokogawa are significantly unprepared to be data driven. Often, customers replace existing big data technologies and the culture has not yet transformed to leverage data as a critical digital asset. Some of the other critical issues in transforming an organization to become data driven include organizational alignment on analytics, overcoming existing master data issues, recruit new talent (data scientists, machine learning experts) and best-in-class data governance practices. In essence, organisations should leverage data as a pathway to drive operational efficiency, growth and sustained operational value improvements.
Pharma companies can look for:
- Secure flexible reporting incorporating data from Batches, Master Recipes, Equipment, Trend values, Alarms and Events.
- Built-in reporting workflow to configure templates, approve templates, assign to report scheduler, run templates to generate reports, approve reports and view reports.
- 21 CFR Part 11 capable option is available, if required.
Here are a few guidelines:
- ‘Out of the box’ integration with Batch control systems, providing immediate usability and benefits without complex engineering and database configuration.
- Standard data analysis capability, providing:
- Automatic calculation and charting of cycle times and unit utilization for each batch.
- Automatically calculated performance ratings for each batch.
- Comparison of batches to peer groups.
- A powerful tool for sorting and comparing batch history data.
- A customizable web-based user interface providing:
- Batch, master recipe and equipment data accessible from one place
- Ad-hoc web access to data without custom display generation.
- Secure data storage with minimal administration.
At Yokogawa, we have understood that both compliance and regulation are required while manufacturing the products and packaging them. In today’s new age IIoT age process automation system is applied in the primary manufacturing of the active pharmaceutical ingredients and process and discrete automation techniques are applied during packaging and formulation — which include compounding, washing, labelling and packing.