Pharma 4.0 is a roadmap developed by ISPE for the pharmaceutical industry to introduce "Industry 4.0" (also called Smart Factory).
In Industry 4.0, continuous development is aimed at improving quality and productivity, reducing costs and ensuring supply stability throughout the entire product life cycle. This is primarily accomplished by reformation of business processes through IT innovation and digitalization.
Furthermore, Pharma 4.0 needs to meet not just business performance aims and objectives, but also obligations arising from governmental regulations specific to the pharmaceutical industry.
In other words, Pharma 4.0 can be viewed as leveraging IT capabilities throughout the entire product life cycle to build quality control processes founded on ICH-Q10 Pharmaceutical Quality System (PQS) guidelines.
To realize Pharma 4.0, it is essential to have IT implementation skills for digitalization and a clear vision that incorporates a detailed understanding of pharmaceutical regulations including PQS.
However, the pharmaceutical industry is caught between the increasing cost of compliance to ensure quality and the need to generate profits.
To move beyond this hurdle, Pharma 4.0 implementation can be of great benefit.
Effective, efficient, and continuous quality improvement efforts based on scientific evidence are necessary (i.e.,POS) throughout the pharmaceutical life cycle and according to that defined in the ICH-Q12 Product Life Cycle Management (PLCM) guidelines.
As a consequence, the compliance cost for quality assurance continues to increase in the pharmaceutical industry.
And in parallel, the industry climate of worsening returns in drug discovery has forced an increased need to extract productivity gains that often include the drug manufacturing process.
To address this idea, the pharmaceutical manufacturing industry has chosen to intensify industrial automation (i.e. Pharma 4.0) and drive business reform through digitalization and in full compliance with pharmaceutical regulatory standards.
Continuously since the 1980s and based on a strategic focus of measurement, imaging, analysis, diagnosis and integration; Yokogawa has offered manufacturing control systems and numerous instruments that support pharmaceutical production processes for active pharmaceutical ingredients (API), drug formulations, and biotechnology applications,
Since 1990s, we have been working on [Industrial Automation] of production in order to realize safe and efficient production by linking the vast amount of information obtained from equipment scattered in the factories and providing various solutions of production management for the utilization.
Beginning around the same time, Yokogawa began also providing live cell imaging solutions that used novel confocal microscope technology to the field of drug discovery and cutting-edge medical research.
By integrating and deepening our core technologies and experience, Yokogawa is developing safer and more efficient autonomous production systems that meet the needs of the pharmaceutical industry, allowing professionals more opportunity to apply uniquely human capabilities such as creativity and innovation to the work-place.
Autonomous production systems will also reduce the reliance on human judgement for decisions regarding pharmaceutical manufacturing, quality testing, documentation and release, thus providing greater consistency and time for staff to focus on higher-level productivity efforts.
We have defined this industry "world-view" as Bio Industrial Autonomy (BIA) and made its realization a mission of the Yokogawa pharmaceutical business organization.
Thus, we will contribute to Pharma 4.0 through the implementation of BIA.
For more information about BIA, click here.
An advanced network that connects information obtained from research, development, and manufacturing will provide a variety of positive effects by enabling complementary utilization of information from each department.
As an example, the concepts of Quality-by-Design (QbD) and Continuous Production can be enabled for new drug development and manufacturing processes. These can have the following effects:
This communication network and cycle enhances competitiveness and fosters continued business growth.
Please refer to the following product groups that provide solutions to pharma customer problems and can help you with your goal attainment.
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Yokogawa Solution List |
|
|---|---|
| 【Production scheduling】 | FLEXSCHE |
| 【Production, sales and cost management】 | mcframe |
| 【Quality management】 | OpreX Laboratory Information Management System |
| 【Environmental monitoring】 | OpreX Environmental Monitoring System |
| 【Equipment maintenance and management】 | eServ |
| 【Process database】 | PI System |
| Exaquantum | |
| 【Procedural automation】 | Exapilot |
| 【Production process monitoring and control】 | Collaborative Information Server (CI Server) |
| CENTUM VP | |
| Field Instruments | |
| 【After-sales service business support】 | ServAir |
Environmental Monitoring Compliant with Pharmaceutical Regulations
OpreX Environmental Monitoring System collects, measures, and stores data such as temperature and humidity as well as other management data to monitor the environment in pharmaceutical manufacturing area, quality control area, and storage area.
Centralized management of user names and passwords using servers on the network is possible through active directory.
Centralized management of the recorded data file
Access Control
Users are assigned to groups and are given access privileges based on the group they belong to.
Only authorized users can login to the system and search and browse through data.
Audit Trails
All file operations by authorized users are recorded in an audit trail file.
Configuration Tool
Adminstrator configures the Data Management Package using this tool.
Monitor measured data in real time
Dedicated viewer software for browsing recorded data
SMARTDAC+ Series
Measure and record a variety of data
Advanced Security Function
Electronic recording of data is compliant with pharmaceutical regulations
Keeping up with a changing marketplace
Pharmaceutical manufacturers are under pressure to keep up with changes such as the shift to low-cost drugs in emerging markets and the demand for drugs that effectively satisfy unmet medical needs. To operate at a profit, manufacturers are looking for ways to improve efficiency and increase productivity. Lean manufacturing is the key.
Yokogawa's Leading-Edge Automation Solutions
Our solutions enable plantwide integration and lifecycle optimization at pharmaceutical plants. Here are some pharmaceutical applications for which Yokogawa provides comprehensive automation solutions and has a global network of experts at your service.
Production Management and Batch Control for Multipurpose Plants
The production of active pharmaceutical ingredients (API) involves batch processes, some of which produce multiple products for a variety of purposes. This necessitates the use of a comprehensive batch control system. The CENTUM VP integrated production control system supplies batch functions based on the ISA-88 batch process control standard and complies with the FDA's 21 CFR Part 11 requirements.
Paperless operations based on 21 CFR Part 11 are becoming more common in the pharmaceutical industry.
The SMARTDAC+® GX/GP Series Paperless Recorders support electronic recording functions that meet the requirements of Part 11. Electronic signatures can be added to the stored data. Yokogawa can offer complete installations with all essential validation documents.
Stable control for product quality assurance
The sterilization and freeze drying processes require high resolution and accurate temperature control in order to assure product quality. The FA-M3V IT machine controller is a high-performance programmable logic controller (PLC) that combines very high processing speeds with stable control features.
Compliance with globalized regulations and guidelines
Pharmaceutical companies operate in a global marketplace and the industry is encouraged to comply with international initiatives such as the PIC/S GMP Guide and the ICH Guidelines. GMP facilities need to follow established best practices and automated production equipment and computer systems are expected to adopt current computerized system validation (CSV) practices such as GAMP.
Assuring the Production of Quality Pharmaceutical Products
Over the years, Yokogawa has successfully realized numerous projects in compliance with Good Automated Manufacturing Practice (GAMP). Under a project validation plan (PVP) that follows the V model described in the GAMP guide, experienced Yokogawa engineers deliver outcomes for the functional specification, design specification, implementation, factory testing, and site acceptance testing phases. The verification and test results, including the installation and operational qualifications (IQ /OQ), serve as objective indicators for determining if project requirements have been met.
Need for a more rigorous approach to ensure product quality
With pharmaceuticals, a rigorous scientific approach is needed to ensure product quality. The ICH quality guidelines call for a quality-by-design (QbD) approach in pharmaceutical development and manufacturing. Manufacturing facilities face the challenge of implementing innovative technologies such as process analytical technology (PAT) and are expected to introduce real-time release (RTR) testing.
Yokogawa PAT Solution to Real-Time Release Testing (RTRT)
Yokogawa's approach to the development of process analytical technology (PAT) solutions relies on real-time monitoring of critical quality attributes (CQA) to achieve lean manufacturing. Online quality attributes can be directly monitored by means of near infrared (NIR) analysis. Another approach is the use of process modeling technology to monitor process health.
