• Industry Introduction / Features

The pharmaceutical industry is derived from the chemical industry and is closely related to "life sciences", mainly involving two sub - fields: biotechnology and pharmaceuticals. Its products include pharmaceutical preparations (such as branded prescription drugs, generic drugs, over-the-counter drugs), active pharmaceutical ingredients, diagnostic substances, and biological products. The industry has the following remarkable characteristics. Firstly, the R&D cost is extremely high. From the initial research discovery to bringing a biotech product to the market, it needs to go through multiple complex and expensive stages, such as clinical trials. The R&D cost of a single new drug can reach as high as $200 - 800 million. Secondly, the R&D cycle is long. On average, it takes 10-14 years for a product to be developed and approved for marketing. This process involves many links such as basic research and clinical trials, and each link faces many uncertainties. Thirdly, it is strictly regulated. It is strictly supervised by agencies like the US Food and Drug Administration (FDA) and the European Union, and must follow a series of regulations such as cGMP and 21 CFR Part 11 to ensure product safety and efficacy. Fourthly, the competition is fierce. It faces challenges such as patent expirations, competition from generic drugs, and difficulties in developing new products. For example, after the patents of many "blockbuster" drugs expire, their market share is severely impacted by generic drugs.

• General Requirements

In production, pharmaceutical companies face challenges such as improving production efficiency, reducing costs, and ensuring product quality consistency. Traditional production methods are relatively inefficient. For example, the utilization rate of factory equipment is only about 50%, the product rework rate is as high as 50%, and the production cycle is long and unstable, which seriously restricts the development of enterprises. The application of automation and digitalization technologies can effectively solve these problems. For example, automated production lines can improve production efficiency and reduce human errors; digital monitoring systems can monitor the production process in real-time to ensure stable product quality. In terms of quality control, the pharmaceutical industry has extremely high requirements for product quality, and any quality problem may have a serious impact on patients' health. Currently, product quality is mainly verified through regular sampling and testing, but this method has certain limitations. Automation and digitalization technologies can achieve real-time monitoring and data analysis of the production process, and timely discover and solve quality problems. For example, the use of Process Analytical Technology (PAT) can monitor the key quality attributes in the production process in real-time, improving product quality while reducing costs. In terms of regulatory compliance, as regulatory requirements become more and more stringent, pharmaceutical companies need to ensure the traceability of the production process, the security of electronic records and signatures, etc. Automation and digital systems can provide complete electronic records and audit trail functions to meet regulatory requirements for enterprises. 

• Digital Factory Solutions

In the process of the pharmaceutical industry's advancement towards intelligence, the digital factory solution provides enterprises with a comprehensive and efficient operation model.

The core system, MES (Manufacturing Execution System), serves as the intelligent brain of the factory, boasting powerful and extensive functions. In terms of production management, it covers every aspect from scheduling to task allocation, enabling precise control over the production process. For the management of basic data such as material and recipes, it can accurately record and control, ensuring the accuracy and consistency of production materials. The shopfloor inventory management function rationally plans the material storage space, enhancing the efficiency of warehouse utilization

.

In the weighing and dispense process, the MES system strictly standardizes the operation procedures to ensure the accuracy of material ratios. The equipment management function monitors the equipment status in real-time and conducts preventive maintenance to reduce equipment downtime due to failures. The SOP (Standard Operating Procedure) production guidance management provides operators with clear and standard operation guidelines to ensure compliant production operations.

During the production execution process, MES enables audit trails and electronic signatures, ensuring the authenticity and traceability of data. The abnormal record management function promptly captures and records production anomalies, facilitating rapid response and handling. The material balance function accurately calculates material input and output to avoid material waste. The electronic batch record review and release ensure the standardization and reliability of production records. The process tracking and product traceability functions provide strong support for product quality trace - back.

The production performance and report analysis functions provide enterprises with data insights, helping to optimize production strategies. The factory intelligent dashboard displays key production data in real-time, enabling visual and intelligent production decision making. The system permission management strictly controls the operation permissions of different personnel to ensure system security. Meanwhile, MES has interfaces for interaction with third-party systems, facilitating system expansion and integration.

LIMS (Laboratory Information Management System) focuses on QC lab management and quality control. From sample receiving, test process management to test result analysis, it strictly adheres to regulations, providing a reliable guarantee for pharmaceutical product quality.

SCADA (Supervisory Control and Data Acquisition), as a data hub, is closely connected to field devices via Ethernet and OPC protocols, collecting equipment and environmental data in real-time and enabling dynamic monitoring of various equipment such as filling and packaging machines.

On this basis, this solution achieves deep integration with the automation control system, including DCS and Batch, WMS (Warehouse Management System), and ERP (Enterprise Resource Planning) system. The automation control system precisely adjusts production parameters based on the collected data to ensure stable production. WMS optimizes the warehousing and logistics management of raw materials and finished products, increasing inventory turnover. The ERP system integrates resources such as finance, procurement, and sales, realizing the coordination and optimization of overall enterprise operations.

Through the coordinated operation of core systems such as MES, the digital factory solution realizes digital and refined production management, visual and intelligent production decision-making, and enables enterprises to reduce costs, improve efficiency, and continuously comply with industry regulations.

• About CSV

In the pharmaceutical industry, computer system validation is of utmost importance for ensuring the reliability of production processes, product quality, and regulatory compliance. With the increasing reliance on automation and digital technologies in pharmaceutical manufacturing, computer systems play a crucial role in various aspects such as production, quality control, and data management. As a result, the validation of these systems has become a key focus in the industry.

Automation control systems, Laboratory Information Management Systems (LIMS), and Manufacturing Execution Systems (MES) are responsible for data collection, processing, storage, and transmission, directly influencing product quality and production efficiency. Any system malfunction or data deviation could lead to product quality issues or even production accidents.

Currently, the industry widely adheres to the GAMP 5 (Good Automated Manufacturing Practices) standard for computer system validation. It has become an internationally recognized guideline for computer system validation. Based on the life cycle model, GAMP 5 adopts a prospective validation concept, helping enterprises develop automated systems that meet regulatory requirements and ensuring that systems remain in a validated state during operation.

Take a large-scale pharmaceutical enterprise as an example. When implementing a new MES system, it strictly follows the GAMP 5 standard for validation. During the project planning phase, the functional requirements and expected performance indicators of the system are clearly defined, and a detailed validation plan is developed. During the development process, the software design and coding are reviewed to ensure compliance with specifications. Before system deployment, an installation qualification is carried out to check whether the hardware equipment is correctly installed and the software configuration meets the requirements. Subsequently, an operational qualification is conducted to test the system's functionality and performance in various actual production scenarios. Finally, a performance qualification is performed to verify whether the system can continuously and stably meet the production process and quality standards. The documentation generated throughout the validation process provides strong support for the system's compliance and also serves as an important reference for subsequent system maintenance and upgrades.

In addition to GAMP 5, pharmaceutical companies also need to ensure that computer systems comply with other regulatory requirements, such as FDA's 21 CFR Part 11. This regulation stipulates requirements for electronic records and electronic signatures, mandating that enterprises establish a comprehensive audit trail mechanism to ensure the integrity, accuracy, and traceability of data. When conducting computer system validation, enterprises need to incorporate these regulatory requirements into the validation process to ensure that the system not only meets functional requirements but also complies with regulatory standards.

In conclusion, computer system validation is a critical link in the pharmaceutical industry to ensure production quality and compliant operation. With the continuous advancement of technology and the increasing stringency of regulations, pharmaceutical companies should continuously pay attention to the update of validation standards and optimize the validation process to ensure that computer systems operate stably and reliably in a complex and ever - changing production environment.