Pharmaceutical | Yokogawa Thailand

ปัจจุบันอุตสาหกรรมยากำลังเผชิญกับความท้าทายที่สำคัญในการใช้ประโยชน์จากโอกาสที่มีอยู่ในตลาดเกิดใหม่ขนาดใหญ่ ปัจจุบัน บริษัท ยาจำเป็นต้องแนะนำเทคนิคการผลิตแบบลีนซึ่งจะช่วยเพิ่มผลกำไรมากขึ้นกว่าเดิม ในฐานะหนึ่งในซัพพลายเออร์ระบบอัตโนมัติทางอุตสาหกรรมชั้นนำของโลก โยโกกาวา มุ่งมั่นที่จะนำเสนอโซลูชั่นที่ดีที่สุดสำหรับแนวทางการผลิตที่ดีที่สุดของคุณ

อุตสาหกรรม แผ่นพับ/โบรชัวร์

เอกสารอ้างอิง eBook

What is Pharma 4.0?

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.

Why is Pharma 4.0 still required?

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.

Yokogawa's business vision in the pharmaceutical business

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.

Effects of Pharma 4.0 Implementations

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:

An early identification of Critical Process Parameters (CPP) and Design Space (DS) through data analysis.
Monitoring of Critical Quality Attributes (CQA) by using Process Analytical Technologies (PAT) such as soft sensors.
Promotion of Real-Time Release Testing (RTRT) of intermediates or finished products by Critical Quality Monitoring.
An enhanced understanding of product characteristics and manufacturing processes based on accumulated data.
Rapid response time to abnormalities and deviations based on data-driven risk assessment by improving accessibility to data
Continued process improvement through feedback and reduction of time and costs involved in developing new drugs and manufacturing processes.

This communication network and cycle enhances competitiveness and fosters continued business growth.

Yokogawa's total solutions to realize Pharma 4.0

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
【การจัดตารางการผลิต】	FLEXSCHE
【การผลิตการขายและการจัดการต้นทุน】	mcframe
【Quality management】	OpreX Laboratory Information Management System
【Environmental monitoring】	OpreX Environmental Monitoring System
【การบำรุงรักษาและการจัดการอุปกรณ์】	eServ
【ฐานข้อมูลกระบวนการ】	ระบบ PI
	Exaquantum
【Procedural automation】	Exapilot
【การตรวจสอบและควบคุมกระบวนการผลิต】	Collaborative Information Server (CI Server)
	CENTUM VP
	Field Instruments
【After-sales service business support】	ServAir

Environmental Monitoring System

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.

Major features

Data Integrity

Meets ALCOA+ requirements

Data Collection and Long-term Storage

Long-term storage of collected data in recorders that are FDA 21 CFR Part 11 compliant

Real-Time Data Monitoring

Monitor measured data and alarms using the monitoring software

Centralized Management for Login User

Centralized management of user names and passwords using servers on the network is possible through active directory.

Centralized management of user name/password in data server and recorders
User login access control

Major fratires

Packages

Data Management Package

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.

การควบคุมการเข้าถึง

Audit Trails

All file operations by authorized users are recorded in an audit trail file.

File operations (archive, delete)
Backup and restore

Audit trail

Configuration Tool

Adminstrator configures the Data Management Package using this tool.

Register new recorders
Register new users
License management

GA10 Real-time Monitoring Software

Monitor measured data in real time

Measured value display (trend display / digital display)
Alarm notification on the screen
Monitor data for each measurement group

GA10

Universal Viewer

Dedicated viewer software for browsing recorded data

Display recorded data
Supports latest OS and offers best viewing quality
Supports 7 languages

universalviewer

Paperless Recorder

SMARTDAC+ Series

Measure and record a variety of data

Add I/O modules as needed
Wide variety of powerful display functions
A full range of network functions

Advanced Security Function
Electronic recording of data is compliant with pharmaceutical regulations

ความปลอดภัยเชิงตรรกะ
ฟังก์ชั่นเส้นทางการตรวจสอบ
Secure data storage in binary format (fraud proof)
Dedicated viewer software

universalviewer

ความท้าทายของลูกค้า

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.

โซลูชั่นของเรา

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.

SMARTDAC+® GX/GP Series Paperless Recorders

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.

ความท้าทายของลูกค้า

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.

โซลูชั่นของเรา

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.

ความท้าทายของลูกค้า

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.

โซลูชั่นของเรา

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.

Real-Time Release Testing (RTRT)