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Strict quality control and achievement of gold quality ——Shenzhen Zixin Pharmaceutical Co., Ltd. strict quality control work sca

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“3·15” publicity day, Zixin Pharmaceutical staff explained drug safety knowledge to the public

Zixin Pharmaceutical Packaging Workshop

In the workshop of the clean area, the employees are operating according to the regulations


On March 15, on the occasion of the 35th International Consumer Rights Day, Jilin Zixin Pharmaceutical Co., Ltd. launched a “3·15” publicity campaign throughout the province.


At the “3·15” consumer consultation service event in Liuhe County, Zixin Pharmaceutical not only displayed its own products and quality signs such as “Jilin Province Quality Award” and “China Well-known Trademark”, but also explained drug safety knowledge to the past citizens. Answer the public's questions about drug safety.


Promoting drug safety knowledge on each consumer's rights day is only a microcosm of Zixin Pharmaceutical's mission to fulfill the mission of the pharmaceutical industry and care for the health of the world.


Established in 1998, Zixin Pharmaceutical Co., Ltd. is a high-tech joint-stock enterprise integrating scientific research, development, production, sales and cultivation of medicinal plants and animals. As a pharmaceutical company that can produce 12 large dosage forms and has 206 drug approval numbers, Zixin Pharmaceutical knows that drug safety is of great importance. Over the years, Zixin Pharmaceutical has always adhered to the tenet of “Taking people to brew medicines with quality”, and regards product quality as a lifeline, starting from various aspects such as system guarantee, process guarantee and personnel protection to ensure the purchase of raw materials for medicines. The quality and safety of the whole process of processing and sales of medicinal materials, carefully brewing safe medicine and conscience medicine for consumers.


Institutional guarantee


Established quality supervision "Disciplinary Committee"


In Zixin Pharmaceutical, there is a “special” department that independently performs its job duties and is not affected by other departments and leaders; it “comes on coming, does not say hello”, often “quietly” Go to a workshop for a surprise inspection. This is the Zixin Pharmaceutical Quality Assurance Department, which was called “Disciplinary Committee” by Zixin people.



In Zixin Pharmaceutical's view, doing a good job in quality management and supervision is inseparable from an effective management system.


In order to do a good job in quality management, Zixin Pharmaceutical has established a relatively complete quality management system. "Finished Product Release Audit Management System", "Material Release Audit Management System", "Manufacturing Process Monitoring and Management Procedures", "Intermediate Products, Released Products Management and Approval Management System"... In order to achieve the standardization and normalization of system management, Zixin Pharmaceuticals continues Improve the quality management system and formulate more than a thousand quality system documents. These documents, from the management of the production environment and production links, to the specification of the production records, are aimed at achieving strict quality control from all processes such as material procurement, production processes, product storage, and release.


Zixin Pharmaceutical has also set up a quality assurance department and a quality control department to form a quality management model that combines production process supervision and product testing. Today, Zixin Pharmaceutical's quality department has more than 40 employees, accounting for 12% of the company's total. Xu Liang, vice president of quality of Zixin Pharmaceutical Co., Ltd., introduced a special self-inspection team to conduct quality supervision and inspection from time to time. “Once employees are found to have violated quality inspection and regulatory actions, they will be dealt with immediately and will be seriously punished at the year-end assessment.”


Management guarantee


Achieve full process monitoring


The system can only be effective if it is implemented in the depth of production. To this end, in addition to establishing a sound quality management system, Zixin Pharmaceutical also strictly controls every aspect of its daily work and production, and strictly guarantees quality and safety to every production process.


Good material can make a good medicine. Over the years, Zixin Pharmaceutical has always attached importance to source control and strictly controlled raw materials. Meng Lingyu, director of Zixin Pharmaceutical Laboratory, said that before the batch of medicinal materials enters the production workshop, the company's laboratory will test the traits, pesticide content and heavy metal content of the medicinal materials, and confirm that the drugs are safe before they can formally enter the workshop. in production. Entering the central laboratory, more than 50 high-performance liquid-phase testing instruments are in sight. These testing instruments are the “safeguards” for Zixin Pharmaceutical to ensure the safety of raw materials.


"When the processing is complicated, it will not dare to save labor. Although the taste is expensive, it will not reduce the material resources." Into the production workshop of Zixin Pharmaceutical, drying room, frying chamber, crushing room, cutting room, washing room... Each workshop door will clearly mark the “safe production responsible person”. The staff of Zixin Pharmaceutical told the reporter that the company strictly follows the quality standards such as the Pharmacopoeia to produce medicines and strictly controls every production detail. Every aspect of pharmaceutical production must be carried out under the strict supervision of quality personnel. At the same time, the staff of each link has strict operation and inspection procedures. Only after confirming that all the processes in this link are qualified, will the products flow into the next link, and absolutely no unqualified intermediate products will be allowed to flow into the next process.


In the product release process, each batch of finished products still needs to undergo strict audit and inspection, and finally the quality is granted by the licensee to ensure that the production process meets GMP requirements. In Zixin Pharmaceutical, the internal control test indicators are 20% to 30% higher than the legal standards. Zixin said that although the upward adjustment of the inspection indicators will increase the company's production costs, it is done to provide genuine medicines to ensure that no unqualified drugs have entered the market.


Personnel protection

Let the safety concept be deeply rooted

Whether it is the system management system or the strict production process, if you want to achieve the desired results, you can't do without human operations. In Zixin Pharmaceutical, quality safety and quality management are not only rooted in the company's business philosophy, but not only in the company's various management systems, but also deeply imprinted in the hearts of every employee.


Crossing the high anti-mouse board and entering the pharmaceutical production workshop, the first thing to do is to standardize the dressing process: taking off life shoes, turning 180°, changing shoes, taking off clothes, washing hands, drying hands, wearing overalls... It seems simple, but it is the first step to put "bacteria" into the production workshop, and it is a step that employees need to repeat day after day.


It is not difficult to do this process well, and it is difficult to perform it carefully every time. In the production workshop of Zixin Pharmaceutical, not only the staff did this, but also the strict requirements for “outsiders” – even wearing the hat first or wearing the clothes first, can you bring the tiny details of the glasses into the workshop, A careful reminder from the staff. In the production hall, employees focus on each process of the work, and after completion, they will organize their work areas according to regulations. According to Zi Xin’s own words, this serious and responsible attitude has already become a work habit.


In order to improve employees' awareness of safety production, each year, Zixin Pharmaceutical will develop a number of training programs to enhance employees' quality and safety awareness.


As the quality standards of pharmaceuticals continue to improve, science and technology continue to develop rapidly, and the requirements for the quality and quality of quality workers are also increasing. Zixin Pharmaceutical Quality Department conducted special training for quality staff for half a year. At the same time, in order to allow them to quickly adapt to the working environment and improve their work abilities, the company specially selected excellent old employees to carry out “transfer, help, bring” and tailored the “Training Period Post Skills Teaching Plan” for new employees. . For the old staff of the Quality Department, a six-month Work Skills Enhancement Plan was designed.


For the staff of other positions, Zixin Pharmaceutical has developed a universally applicable training plan for everyone, and also developed specialized skills and quality and safety knowledge training for different job responsibilities to ensure that in the whole process of drug production, The staff can tighten the string of quality and safety and keep the quality and safety moment in mind.


Every year, the company conducts quality assessments of employee operations, and the results of the assessment will directly affect the employees' annual assessment results.


Hard work pays off. Strict quality control has won tangible benefits for Zixin Pharmaceutical. In the 19-year development of Zixin Pharmaceutical, there has never been a drug safety related complaint. Zixin Pharmaceutical also won the “word of mouth” for patients because of its excellent product quality.


Zixin Pharmaceuticals often receives calls from patients and consults the purchase address. It turns out that although some products are also sold by other manufacturers, many patients only recognize the brand of "Zixin". In their view, they saw the "Zixin" and they gave their heart to the quality.


The gold cup silver cup is not as good as the consumer's reputation. This trust from consumers is the best compliment to Zixin Pharmaceutical's quality control work.