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Quality management of pharmaceuticals according to international standards with Pharmasoft

Quality management of pharmaceuticals is one of the crucial factors in ensuring the safety and efficacy of medical products. To achieve this goal, businesses need to adhere to international quality standards such as WHO-GMP, EU-GMP, and others. However, complying with these standards is not an easy task and requires investment in human resources, equipment, and technology.

Quality management of pharmaceuticals according to international standards with Pharmasoft

 

Quality management of pharmaceuticals according to international standards with Pharmasoft

One effective solution to help businesses manage quality efficiently and cost-effectively is to utilize the Pharmasoft ERP software. This specialized enterprise management software for the pharmaceutical industry is developed by EnterSoft Software Solutions Joint Stock Company.

  1. 1. The concept of pharmaceutical quality management

Quality management is the process of ensuring that products meet the requirements and expectations of customers, as well as technical and legal standards. Quality management of pharmaceutical products includes activities such as quality planning, quality design, quality testing, quality control, quality assurance, and quality improvement.

  1. 2. International standards for pharmaceutical quality management

International standards for quality management of pharmaceutical products can be classified as follows:

  • ▪ ISO standards (International Organization for Standardization): This includes ISO 9001 and related standards for the quality management of products. ISO standards ensure consistency in quality management processes within businesses and enhance the reliability and effectiveness of production, quality control, and product distribution activities.

  • ▪ GMP standards (Good Manufacturing Practice): This is an important standard in the pharmaceutical industry to ensure the safety and quality of products. GMP standards encompass regulations on manufacturing practices, quality control, and document management. They ensure that products meet the quality and safety standards of the pharmaceutical industry. Some common GMP certifications include WHO-GMP, ASEAN-GMP, EU-GMP, etc.

  • ▪ GLP standards (Good Laboratory Practice): This is a standard that ensures the accuracy and reliability of test results in laboratories.

  • ▪ GCP standards (Good Clinical Practice): This is a standard that ensures the safety and quality of clinical trials.

  • ▪ GDP standards (Good Distribution Practice): This is a standard that ensures the safety and quality of pharmaceutical product distribution activities, including transportation, storage, and product handling.

Compliance with these standards is essential for pharmaceutical businesses to ensure the safety and quality of their products, as well as to comply with relevant legal regulations in the pharmaceutical manufacturing industry.

  1. 3. Pharmasoft ERP Software in pharmaceutical quality management

Pharmasoft is a comprehensive Enterprise Resource Planning (ERP) software designed specifically for the pharmaceutical industry. This software helps companies manage and monitor their operations, from production to distribution, including product quality management.

Pharmasoft provides various functionalities to manage product quality, including process management, quality management and analysis, material management, and supplier management. With Pharmasoft, pharmaceutical companies can easily monitor all aspects of the production process and ensure that their products meet international quality standards.

  1. 4. Functions and Benefits of Pharmasoft ERP Software in pharmaceutical quality management

Pharmasoft also provides advanced functionalities to monitor and manage pharmaceutical quality, including document management, product records, and production processes. This enables companies to comprehensively manage and monitor their operations.

The Pharmasoft ERP software offers the following functions and benefits for product quality management:

  • - Close monitoring and control of the origin, batch numbers, and expiration dates of raw materials and finished products.

  • - Management and inspection of the quality of incoming materials, production processes, finished products, and products sold.

  • - Storage and reporting of quality data based on criteria such as product codes, batch numbers, production dates, inspection dates, test results, and personnel responsible for testing.

  • - Ability to integrate with other systems such as financial management, inventory management, and customer management. This enhances the connectivity between various company operations and creates an integrated management system.

Overall, Pharmasoft ERP software is an essential tool for managing product quality in the pharmaceutical industry. With its functions and benefits, Pharmasoft helps pharmaceutical companies ensure that their products meet quality standards and customer requirements.

  1. 5. Product Quality Management Process of PharmaSoft ERP System

PharmaSoft software provides functionalities to support pharmaceutical quality control processes. The process includes the following steps:

Product Quality Management Process of PharmaSoft ERP System

Product Quality Management Process of PharmaSoft ERP System

  • - Testing Standard Catalog: Created to store information about testing standards, including names, codes, descriptions, testing methods, and standard requirements.

  • - Testing Standards: Include standards for evaluating product quality. These standards are stored in the testing standard catalog.

  • - Testing Sample Form: Used to store information about product samples taken for quality testing. The form includes the name, code, batch number, sampling date, and information about the sampler.

  • Conducting Testing: Through the software's functions, users can input information about testing results, including measured values and product quality evaluation results.

  • Testing Result Verification: The software automatically verifies testing results and displays notifications if the product does not meet the standards.

  • Warehouse Entry Confirmation: After the product has undergone testing and quality confirmation, the software allows users to confirm warehouse entry.

Applying this process ensures that the manufactured products meet quality standards, enhance production efficiency, and improve product quality management. Through the management of production processes and quality control systematically, data analysis, and information management, the PharmaSoft ERP system helps manufacturers maintain control over product quality while optimizing processes.

  1. 6. Benefits of Implementing PharmaSoft ERP Software in Pharmaceutical Quality Management

Implementing PharmaSoft ERP software in quality management brings significant benefits, including:

  • - Enhancing accuracy and reliability of quality control processes, reducing the occurrence of errors and mistakes.

  • - Minimizing time and costs in quality management, from defining the list of testing standards to conducting tests and confirming warehouse entry.

  • - Improving the ability to monitor and supervise quality management, detecting issues and deficiencies early on, while enhancing responsiveness and problem-solving capabilities.

  • - Strengthening the integration among departments involved in the quality management process, ensuring accurate and swift information sharing, thus increasing work efficiency.

  • - Supporting testing procedures and monitoring quality across the entire supply chain, ensuring safety and product quality for end consumers.

  • - Meeting the accreditation requirements of regulatory agencies, ensuring that products meet industry standards and regulations.

  1. 7. Conclusion

With the continuous development of technology and the increasing demand for quality, implementing ERP software in product quality management is essential for manufacturing enterprises today. Especially with international standards such as ISO 9001, GMP, and GLP, using PharmaSoft ERP software helps businesses easily comply with these standards effectively.

PharmaSoft ERP software not only automates the pharmaceutical quality management process but also enhances transparency and monitoring capabilities, minimizing risks and costs in quality management. With its notable advantages and the necessity of quality management, applying PharmaSoft ERP software will undoubtedly help pharmaceutical manufacturing enterprises enhance management efficiency and achieve the highest international standards. If you are interested in PharmaSoft ERP software, please contact us for consultation and support.


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