Innovative paperless manufacturing in the pharmaceutical industry

Asia is a region rife with exponential growth opportunities. This is no different for the healthcare industry. Factors such as increased incomes, expansion of the middle class, higher life expectancy, surge in chronic diseases, as well as growing government healthcare investments are fuelling the demand for healthcare products and services in the region. Adopting innovative technologies and going paperless is a move that manufacturers should look into in order to improve pharmaceutical processes, maintain high product quality and reduce risk.

According to BMI Research, Asia Pacific is projected to see medicine sales increase by 5% year-on-year this year, from US$305 billion to US$321 billion. Thanks to the rollout of universal healthcare, penetration of global companies and an increase of private healthcare providers, the region possesses an abundance of opportunities in the healthcare and pharmaceutical markets.

The pharmaceutical manufacturing industry, in particular, is expected to grow exponentially in the next few years. This is largely due to the fact that governments in Asia Pacific have been aggressively pushing to cultivate and grow the industry in order to boost their country’s economy.

A good example is Singapore, which has evolved into one of the most important healthcare hubs in the world, thanks to its geographic location, world-class infrastructure, skilled workforce and favourable government policy initiatives. The Singapore Economic Development Board (EDB) notes that more than 30 of the world’s leading biomedical sciences companies have chosen Singapore as the key location for their manufacturing and R&D activities, and at the same time set up their regional headquarters here. This has allowed them to identify strategic business opportunities while accelerating product innovation and growth in the region.

The need to constantly remain efficient

One of the main challenges that have been observed or experienced by fast-growing pharmaceutical companies is the need to keep up with customer demands in terms of quantity, quality and immediacy. Product quality and safety are of utmost priorities, but at the same time, they have to cut costs while constantly enabling innovations in order to remain competitive.

Healthcare products have to go through highly complex and often, lengthy processes before medical practitioners and consumers can use it. In this process, all manufacturing steps have to be accurately recorded, which means there are massive costs and time required for manual documentation.
Additionally, creating and maintaining master batch records (MBRs) in a paper-based environment involves huge effort. During production, there may be issues such as human error, duplication of information due to multiple systems and unnecessary time spent to gather and input all relevant data. The review and reconciliation of this information can also be very time-consuming and subject to unforeseen mistakes.

Standardisation in the definition of the different manufacturing processes is also even more difficult because information is not always centralised. Analysis of the key performance indicators of executed batch records is possible only after the labour-intensive re-entry of data from disparate systems.

With all these challenges in mind, manufacturers need to look at adopting the right technology to enhance their production processes. Being innovative would enable them to adhere to Good Manufacturing Practice (GMP) guidelines by setting and maintaining high standards of performance while reducing costs and minimising risks.

Go paperless

Electronic master batch record management with a manufacturing execution system (MES) is based on master batch record templates that are subject to automatic version management. Master batch record/electronic batch record (MBR/eBR) systems provide the ability to create standardised processes or sub-processes and facilitate their maintenance and validation.

These systems provide a framework for setting up and generating an empty eBR form for data collection during production. Then the required production parameters are distributed to the relevant systems for execution. The MES then automatically synchronises and collects all batch-related information into an eBR.

This approach provides error reduction and prevention as well as data centralisation for further analysis.

An integrated solution for paperless manufacturing

Siemens offers a paperless manufacturing solution for enhancing both efficiency and product quality, while at the same time bringing down risk and costs.

For several years, Simatic IT eBR has been successfully applied in MBR and eBR management. Step by step, the solution follows the lifecycle of the batch record, taking advantage of the wide range of out-of-the-box MES functionalities, such as order management, tracking and tracing of materials, and equipment management.

The new Simatic IT eBR 6.1 facilitates the implementation of the paperless manufacturing. With a new Master Batch Record module and a "Project Startup" package, it provides a list of out-of-the-box deliverables to speed up project execution time. In addition, it offers native integration with Siemens PCS 7 Batch and new access to electronic work instruction lists embedded in SCADA/HMI clients. By accelerating the design, execution, review and release of regulated production processes and electronic batch records, Simatic IT eBR helps both enhance product quality and lower production costs.

To further simplify the implementation and operation of an eBR solution, the latest version of Simatic IT eBR features a web-based MBR module. This facilitates the management of key process parameters and offers native integration with the Simatic solution in the automation layer. With the new MBR module, users can easily acquire definitions for critical process parameters (CPPs) and critical quality parameters (CQPs). These are configured directly in the system or sourced from enterprise resource planning (ERP), product lifecycle management (PLM), or general recipe systems.

Together with product and process recipe definitions, these key parameters can then be used to create a comprehensive description of the batch record. This helps reduce engineering time and significantly accelerates the introduction of new products. The native integration between Simatic IT eBR and Simatic PCS 7 helps streamline the entire batch record lifecycle from design to execution and review.

During the design phase, Simatic IT eBR provides users with the ability to browse batch recipes and directly use eBR-relevant critical parameters that are defined in the batch system. Users can define the set points and threshold values for automatic and manual process actions based on MBR data. The integration of the MES and the distributed control system (DCS) enables the capabilities of each system to be used in one environment: a robust and powerful batch engine in the DCS for complex low-level S88.01 recipes, and an intuitive and easy-to-use tool in the MES to design processes and implement parametric MBRs according to S95 standards. The recipe information is available directly in the MES tool, and desig­ning MBRs is greatly simplified.

During production execution, every key process parameter defined in the MBR is enforced in the eBR execution. Manual operations are guided with electronic work instructions; automated operations are controlled by the DCS; and every resource used across the process is verified, tracked, and traced. Quality testing (in-line, at-line, and off-line sampling) is completely integrated during the execution of the process. Alarms and alerts are recorded in the MES and can be configured to trigger corrective or preventive actions. In addition, the system will aggregate charts and reports as part of the eBR, which is based on real-time data and can be accessed anytime.

In the review phase, this solution enables the electronic release of the batch by exception. In addition, the integrated manufacturing intelligence tool allows review and comparison of batch data to identify potential for improvement, thus supporting operational excellence initiatives.

Manufacturers, if they have not already, should look at going paperless and adopting innovative technologies in order to improve pharmaceutical processes, maintain high product quality and reduce risk.