Source of Quality



Source of Quality

What is the quality of the product? Some people say, "Can the product meet the requirements of consumers", some people say, "Damaged or deteriorated, its quality is poor, otherwise it is a good quality product". It can be seen that quality, including the objective characteristics of the product, also contains the subjective requirements of people, so in the subjective requirements, but also developed a series of quality standards. Quality standards play an important role in enterprises. In the process of drug research and development, production and inspection, quality standards are written into laws and regulations, guiding the whole production process of products from scratch. So, where do these quality standards come from and form a unified understanding from the inspection results of the final product? Or is the production stage strictly in accordance with the process and the final inspection results? Or from the design and development phase of the drug?

The quality of drugs originates from inspection. Inspection is an after-the-fact behavior. When the quality of samples is uneven, only the right amount is taken for inspection, and the result cannot reflect the quality of the whole batch of drugs. Drug quality comes from the production, drug research and development stage, the production process of the drug has not been fully optimized, screened, verified, so even if strictly in accordance with the process of production, still can not guarantee the quality of the drug produced. Therefore, the quality of drugs is produced through good design, and quality control is carried out from the research and development stage.

Quality comes from design, which is to consider the quality of the product at the source-R & D stage. As a member of Lijiexun R & D Center, I deeply realize the importance of drug quality. The design of drug quality is based on the summary of the target product quality as the starting point, on the basis of understanding the key material attributes, through experimental design, understanding the quality attributes of the product, establishing the key process parameters, in the raw material characteristics, process conditions, environment and other factors, to establish a design space that can meet the product performance. These are also what I need to come into contact with in my future work, and also what I need to learn and understand deeply.

Whether it is product quality or service quality, in the final analysis, it depends on the "quality" of the people who make products and provide services ". As an employee of Lijiexun, in the process of drug research and development, production and inspection, it is reasonable to put the quality concept in the first place, pursue perfect quality, start with small things, do a good job in details, and carry out production operations in strict accordance with quality standards. produce good drugs that reassure consumers.

(Author: Lin Lizhi)