Biopharmaceutical industry as an important part of China's strategic emerging industries, the quality of its products is directly related to the life and health of the people. This paper analyzes the important role of quality assurance in the production process of biopharmaceuticals from the perspective of biopharmaceutical production support system, and puts forward corresponding measures and methods, with a view to providing reference for the sustainable development of China's biopharmaceutical industry.

Biopharmaceuticals It refers to the use of biotechnology to produce drugs with good efficacy, low side effects, targeted and other characteristics. In recent years, with the rapid development of biotechnology, the biopharmaceutical industry has achieved remarkable results worldwide. China's government attaches great importance to the development of biopharmaceutical industry and has listed it as a national strategic emerging industry. However, the quality assurance problem in the production process of biopharmaceuticals has become a bottleneck restricting the development of the industry. The purpose of this paper is to discuss the quality assurance problems in the biopharmaceutical production support system to provide a reference for China's biopharmaceutical industry.

Overview of the biopharmaceutical production support system

The biopharmaceutical production support system mainly includes: Raw material supply, production equipment, production process, quality control, warehousing and logistics, sales service and other links. The following is a brief introduction to the main content of each link:

1. Raw material supply: biopharmaceutical raw materials mainly include biological raw materials, chemical raw materials and excipients. The quality of raw materials directly affects the quality of the final product.

2. Production equipment: Biopharmaceutical production equipment requires high precision, high cleanliness and high automation. The selection and maintenance of the equipment is critical to the quality assurance of the production process.

3. Production process: Biopharmaceutical production process includes fermentation, extraction, purification and preparation. Process optimization and stability is the key to ensure product quality.

4. Quality control: Quality control includes quality testing of raw materials, intermediates, and finished products, as well as monitoring of the production process.

5. Warehousing and logistics: Warehousing and logistics are required to ensure the quality and safety of raw materials and finished products during storage and transportation.

6. Sales service: sales service mainly includes marketing and after-sales service, which is important for improving product quality and satisfaction.

The role of quality assurance in biopharmaceutical production support system

1. Ensure product quality: the quality assurance system can strictly monitor all aspects of the production process to ensure that product quality meets national standards.

2. Improve production efficiency: By optimizing the production process and reducing the rate of defective products, we can improve the production efficiency and reduce the production cost.

3. Enhance market competitiveness: High-quality products and services help to improve corporate brand image and enhance market competitiveness.

4. Satisfy regulatory requirements: Quality assurance system helps enterprises to meet the requirements of national and industry regulations and avoid legal risks caused by quality problems.

Measures and methods of quality assurance in the biopharmaceutical production support system

1. Establishment of a sound quality management system: Enterprises should establish a sound quality management system in accordance with the requirements of GMP (Good Manufacturing Practice) to ensure that the production process is standardized and standardized.

1. Strengthen the management of raw material suppliers: Strictly audit the raw material suppliers to ensure that the quality of raw materials is qualified.

2. Optimize production process: improve product quality through technological innovation and process optimization.

3. Improve the quality of employees: Strengthen the training of employees, improve the quality awareness, and ensure that the production process is stable and controllable.

4. Strengthen quality inspection: adopt advanced quality inspection equipment and methods to ensure product quality.

5. Strengthen the management of production equipments: Regularly maintain and overhaul the equipments to ensure stable operation.

6. Establish a traceability system: to realize the whole process of traceability from raw materials to finished products, which is convenient for problem identification and accountability.