Pharmaceutical Edition

Yokogawa's role

Pharmaceuticals play an essential role in ensuring that people can enjoy good health and well-being. To ensure that pharmaceutical plants produce high quality and reliable medicines, they follow Good Manufacturing Practice (GMP) manufacturing and quality control standards that cover everything from the receipt of raw materials through to production and shipment.
Yokogawa supports pharmaceutical plants by providing a wide range of solutions, including measurement devices such as flowmeters and level meters; analytical devices such as pH analyzers and conductivity analyzers; and control and information systems. Our information systems help to improve data utilization and operational efficiency by managing work instructions, recording and tracking manufacturing operations, and handling quality information and assurance tasks throughout each stage of the production process.

How pharmaceuticals are made

Pharmaceuticals come in various types and forms and are manufactured using chemical synthesis or cell cultures. Yokogawa contributes broadly across the pharmaceutical spectrum—from the production of active pharmaceutical ingredients (APIs) to final formulation—for small molecule drugs (conventional pharmaceuticals), medium molecule drugs (e.g., peptide-based), and large molecule drugs (biopharmaceuticals).

In this section, we will be taking a closer look at small molecule and large molecule drugs.

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As for small molecule drugs that are to be administered using oral solid dosages, APIs are transported to the formulation plant, where they are processed into a suitable dosage form based on intended use, expected effects, and the timing of those effects after administration. Personnel in charge of the formulation process proceed with this work while checking the types of raw materials, required quantities, and work procedures. All work records are managed by the manufacturing execution system (MES). Once the results of quality testing and the records from the MES confirm that the product has been properly manufactured, the pharmaceuticals are shipped.

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 Receipt and storage of raw materials

After confirming the quality of raw materials such as APIs, additives, and packaging materials, they are delivered to the formulation plant and stored and managed in the raw materials warehouse.

 Weighing

In accordance with work instructions that are based on the production plan, the required quantities of designated raw materials are accurately weighed.

 Granulation

The weighed raw materials are processed from powder form into granules. Under specified conditions and following established procedures, the granules are given a uniform size and shape.

 Mixing

Additives are added to the granulated particles and put into a mixer, where they are mixed thoroughly to evenly distribute the components.

 Tableting

The uniformly mixed granules are placed into a tablet press to form tablets. The finished tablets are sampled regularly to measure characteristics such as weight, thickness, and hardness.

 Coating

To protect the tablets from light and moisture and control the timing of the drug’s effect after administration, a sugar or thin film coating is applied to the surface of the tablets.

 Visual inspection

Using cameras, the tablets are inspected for shape, dirt, chipping, cracking, and discoloration. Defective products are removed, and tablets that pass inspection proceed to the packaging process.

 Packaging

The tablets are packaged in specified configurations. Together with package inserts, the individual boxes are packed into cartons and transported to the product warehouse.

 Product storage

Cartons in which the tablets have been packed are stored and managed. A warehouse management system is used to provide instructions for transportation within the plant, direct incoming and outgoing cartons, and manage inventory, thereby helping to prevent shipping errors and operational mistakes.

 Product shipment

After shipment approval, the products are shipped to pharmaceutical trading companies or wholesalers.

Information management in pharmaceutical manufacturing

In order to consistently supply high-quality and reliable pharmaceuticals to the market, it is necessary to thoroughly implement manufacturing management, quality control, and quality assurance in accordance with GMP. Yokogawa helps to improve productivity and ensure quality by integrating information related to production activities and manufacturing processes, thereby preventing an over-reliance on individual expertise.

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The role of each information system

Managing overall production activities (Production Management System – PMS)

The PMS integrates information related to pharmaceutical production, including manufacturing, sales, procurement, and costs. It streamlines pharmaceutical operations from production planning to manufacturing, inventory, and quality control. The PMS also connects with the manufacturing execution system (MES) and the laboratory information management system (LIMS) to ensure that manufacturing is done in accordance with the production plan.

Ensuring Quality (Quality Management System – QMS)

In the event of occurrences that can affect quality or safety, such as changes or deviations, and to prepare for annual audits, the QMS records and manages data related to all quality assurance activities, including data from the LIMS and the MES, to ensure quality and safety.

Inspecting Quality (Laboratory Information Management System – LIMS)

The LIMS manages the items measured during quality testing of raw materials, intermediates and finished products, along with the test specifications and results. It uses data from analytical instruments to conduct tests and manages the results as test reports, helping prevent data errors, tampering, and inconsistencies, thereby ensuring the accuracy of quality inspections. The LIMS also integrates with the MES, QMS and the PMS to improve the efficiency of quality testing operations.

Managing the Manufacturing Process (Manufacturing Execution System – MES)

The manufacturing of pharmaceuticals is subject to various strict regulations, requiring thorough production and quality control. The MES visualizes and records work instructions, implementation details, progress status, and production data for each process according to the production plan, enabling manufacturing in compliance with GMP.

Managing Logistics (Warehouse Management System – WMS)

The WMS manages the locations, storage conditions, container transport instructions, and inventories of raw materials, intermediates, and finished products within a pharmaceutical plant. It helps prevent mistakes in selecting or adding raw materials and supports operational efficiency.

Monitoring the Environment (Environmental Monitoring System – EMS)

Pharmaceutical plants require monitoring of work environmental data such as temperature, humidity, and differential pressure between rooms. The EMS collects data from temperature sensors, hygrometers, and pressure transmitters, and works with recorders to log and store data in real time. Even during non-production hours, it continuously monitors environmental conditions to support regulatory compliance and risk management.