The more than 100 days and nights that have just passed are bound to be extraordinary and memorable. The sudden outbreak of COVID-19 has thrown people and businesses into a war without smoke. When there are battles, we must respond positively. How to deal with, for enterprises, fight is not only perseverance, but also strength. As an important member of domestic pharmaceutical enterprises, Yangzijiang Pharmaceutical Group has delivered a satisfactory answer paper with high quality in the face of the big exam.

Critical period in the outbreak, the first rescue of wuhan Yangtze river pharmaceutical group, medical institutions throughout all the provinces in succession donated a large amount of protective equipment and medicine, and on January 26, emergency production, in process and production safety with the staff at the same time, to find ways to overcome the work personnel, poor transportation, raw materials procurement difficult problems, such as, Overtime is being worked to produce urgently needed antiviral drugs. At the same time, it actively participates in the "Three Guarantees Action" (price, quality and supply) carried out by the State Administration of Market Regulation, and practices the responsibility and responsibility of pharmaceutical enterprises. After outbreak control, effective resume work and production group subsidiaries, and launched in February 25 group 43 times "quality brand safety environmental protection month" activities, with "the epidemic, production" as the theme, around the "disease prevention and control of brand first, quality first, safety environmental protection first, ensure supply first" activities, writing the resistance to disease and production's pen.

In the special period of epidemic prevention and control and resumption of work and production, Yangzijiang Pharmaceutical Group firmly holds on to the string of quality risk, keeps innovating, pursues excellence, and plays a new movement of high-quality and efficient development once again.

The quality risk control mode has been upgraded to the local standard of Jiangsu Province

The quality of the Yangtze river pharmaceutical group risk control mode is concise in long-term production quality management by the Yangtze river, and the risk control as the essence of drug quality management requirements, on the basis of risk management related to the advanced international standards and methods to carry on the innovation and development, has been clear about the "how" and "do", from the inside out, A quality risk control mode guided by "no risk for patients, no risk escalation, no risk transfer to other parties" and "continuous questioning, continuous identification, continuous control, and continuous review" should be established to carry out high-quality management of drug quality risks throughout the process.

On April 9, 2020, Jiangsu Provincial Bureau of Market Supervision published the 9th batch of Jiangsu Provincial Local Standard Catalogue, among which the Drug Production Enterprise Quality Risk Control System Requirements jointly drafted by Yangzijiang Pharmaceutical Group and Shanghai Academy of Quality Management Science was listed. The standard, the first local standard for a management system led by a pharmaceutical company in Jiangsu Province, was formally implemented on May 15.

Quality risk control system is an important part of quality system. Quality risk management (QRM) is defined in China's pharmaceutical GMP (2010 revision) as "a systematic process of assessing, controlling, communicating and reviewing quality risks in a forward-looking or retrospective manner throughout the product life cycle". That is to say, as a special product, the risks of drugs not only come from the inherent characteristics of adverse drug reactions, but also from process errors (such as the wrong identification of information such as the production date and expiration date of oral solid preparations) and system errors (such as the failure of the quality audit of the material supplier).

"We started the standard project in 2018. Through active practice, the company has established a set of scientific, rigorous and efficient quality risk control mode in drug quality management -- a drug quality risk control mode with the mission of "seeking, forging ahead and protecting all sentient beings". This model fits the characteristics of the pharmaceutical industry, and its approach can effectively control drug quality risks, which is scalable." Reference to this standard has been implemented, deputy chief engineer of the quality of the Yangtze river pharmaceutical group brand Xu Kaixiang said happily, "the company as a quality management standard enterprise, has an obligation to the experience of controlling quality risk sharing to the whole industry after standardization, standardization, to lead and promote the pharmaceutical industry in jiangsu province quality risk management to a new level, We will continue to promote the healthy development of the drug manufacturing industry."

The local standard of "Requirements for Quality Risk Control System of Pharmaceutical Manufacturing Enterprises" absorbs the advanced concepts of GB/T 19001 quality management system requirements, GMP for pharmaceutical production, ICH Q9 quality risk management, ISO31000 risk management and GB/T 19580 performance excellence management mode. From seven aspects of basic concept, leadership and organization, resource allocation, system planning, control process, process application, and evaluation and improvement, a systematic guide for the establishment and implementation of quality risk control system suitable for related enterprises in the pharmaceutical production industry was provided. In the appendix, the standard also summarizes the quality risk control experience of Yangzijiang Pharmaceutical Group in the four main business processes of R&D, procurement, production and marketing, and shares specific cases. Such as Pharmaceutical Research Design and Implementation Stage Control Method for Chemical Generic Drugs, Process Design and Implementation Stage Control Method for the Management of Raw Materials and Packaging Materials Suppliers, Process Design and Implementation Stage Control Method for Aluminium Plastic Packaging for Solid Drugs, and Process Design and Implementation Stage Control Method for Drug Information Traceability Management.

In the opinion of Xu Jingren, chairman of Yangzijiang Pharmaceutical Group, drug quality risk management should be linked to the ultimate goal of protecting patients. Because of this, the company has determined the "pharmaceutical for parents, pharmaceutical for relatives" quality culture, and diligently pursue and practice.

In addition to the local standards of "Requirements for Quality Risk Control System of Pharmaceutical Manufacturers", this year, Yangzijiang Pharmaceutical Group continues to promote the construction of the project of "Standardization Pilot (Demonstration) of High-tech Industry in Intelligent Manufacturing of Traditional Chinese Medicine Process" by the National Standards Committee, and at the same time, it begins to formulate 5 standards related to the intelligent factory of traditional Chinese medicine. In 2018, Yangzijiang Pharmaceutical Group undertook the construction of Standardization Pilot Project (Demonstration) of High-tech Industry in Intelligent Manufacturing of Traditional Chinese Medicine Process, which was implemented by its subsidiary Jiangsu Longfengtang Traditional Chinese Medicine Co., Ltd. (hereinafter referred to as Longfengtang). At present, Longfengtang has made beneficial attempts in the aspects of automatic transmission and whole-process traceability management of TCM decoction pieces, which greatly guarantees the consistency of TCM product quality.

According to reports, the five standards of Chinese medicine intelligent factory are completed by Yangzijiang Pharmaceutical Group and the China Institute of Standardization, aiming to promote the transformation of intelligent and standardized processing of Chinese medicine and improve the quality of Chinese medicine products. At present, the local standard of "Quality Control of Water and Alcohol Extraction Process of Traditional Chinese Medicine in Smart Factory of Traditional Chinese Medicine" has entered the final review stage and is expected to be released soon. Another four standards, also strive to pass efforts before the end of this year debut.

"At present, China's TCM industry faces severe challenges from insufficient inheritance and innovation." Xu Jingren said that Yangzijiang Pharmaceutical Group hopes to realize the rapid development of traditional Chinese medicine transformation through Longfengtang and promote the pace of Chinese traditional Chinese medicine to the world.

Since its establishment 49 years ago, Yangzijiang Pharmaceutical Group has focused on the market needs and technological trends, focusing on the special requirements of drug manufacturing, and devoted itself to standard research and innovation. By the end of 2019, a total of 198 national drug quality standards had been set, and most of its products had internal control standards set by enterprises. Company also participated in the National Administration of Traditional Chinese Medicine of traditional Chinese medicine industry special scientific research projects, such as rhizoma ligustici wallichii 80 flavour research on Chinese traditional medicine recommended international quality standards, to form a core team of experts, domestic research on traditional Chinese medicine (TCM) standard in the study of international quality standards, to undertake a study of 15 kinds of quality standard, at present, there are five taste of traditional Chinese medicine international recommendation has been adopted by the European pharmacopoeia.

Risk awareness builds the safety protection wall first

Yangtze river pharmaceutical group in the recently held in the first half of 2020 work summary on the meeting, Xu Kaixiang about the second half of this year the company in quality brand management will be the key to carry out the new revision of the pharmaceutical administration law and related regulations and normative documents and technical guidelines, and in December 30, 2020 "China pharmacopoeia" on the implementation of, and so on and so forth, Again, the company's attention.

"The introduction and change of each regulation have put forward new requirements for enterprises and industry risk management awareness and ability. We must prepare in advance and respond actively to effectively control all kinds of hidden dangers and truly achieve production safety." Xu Kaixiang said.

Citing a new version of the Chinese Pharmacopoeia, which will be implemented by the end of this year, he said one of the biggest changes in Yangzi Pharmaceutical Group's view is stricter controls on exogenous contaminants in traditional Chinese medicines, including testing for all heavy metals that affect product quality and 33 pesticide residues. "The previous' Chinese Pharmacopoeia 'did not have such strict requirements, whether heavy metals exceed the standard, whether pesticide residues, some to test, such as American ginseng, licorice and a few other Chinese medicinal materials only tested nine organochlorine pesticide residues; Some are not checked, such as notoginseng, angelica and other heavy metals and harmful elements. The 2020 edition of the Chinese Pharmacopoeia requires that '33 pesticides banned in medicinal materials and prepared pieces (plants) shall not be detected,' and it also increases the detection requirements for heavy metals and harmful elements." Xu Kaixiang said.

The Chinese Pharmacopoeia is the core of the national drug standard system and the basic guarantee for drug manufacturers to ensure product quality. It is revised every five years to continuously improve and improve the quality of drugs. The 2020 edition of the Chinese Pharmacopoeia puts forward higher and stricter requirements for overall quality control, especially the quality control and safety level of pharmaceutical excipients, as well as the application of advanced and mature testing technologies, marking a new level of drug standards in China.

In recent years, the excessive residues of heavy metals and pesticides in the planting process of Chinese herbal medicines have been a concern, which has also become an important bottleneck restricting Chinese herbal medicine products from going abroad. In order to change this situation and improve the competitiveness of Chinese traditional medicine in the international market, the 2020 edition of Chinese Pharmacopoeia has made significant changes in this aspect. This change is a new challenge for all pharmaceutical enterprises, which must be actively dealt with in terms of consciousness and action in order to prevent any problems.

It is reported that the 2020 edition of the "Chinese Pharmacopoeia" revision and consultation period, Yangzijiang Pharmaceutical Group has organized a study for the changes, and developed relevant measures. Xu Kaixiang introduced that in addition to learning in advance, the company is also in the purchase of advanced testing equipment, from abroad to purchase reference products to take the lead in qualitative and quantitative analysis and other aspects of the action, and plans to invite relevant experts to the company in the next two months for systematic training, optimization of the implementation strategy and implementation. "We have to take risk assessment first." Xu Kaixiang emphasized that.

According to introducing, it is because of the advanced consciousness of risk control, in 2012, an outbreak of "poison capsule" event, many pharmaceutical companies because of choose and buy the use of industrial gelatin production of hollow capsule, are involved, the product reputation and brand, product sales, but the Yangtze river pharmaceutical group away from the event. Investigate its reason, is the high risk early warning consciousness has built the security protection wall. Because the 2010 edition of the Chinese Pharmacopoeia, the amount of chromium in hollow capsules put forward new requirements. Based on this change, Yangzijiang Pharmaceutical Group purchased relevant equipment such as atomic absorption spectrometer to detect the content of heavy metals in materials in advance, and carried out strict self-control on the content of chromium in capsules to ensure the safety and quality of products.

The risk awareness of Yangzijiang Pharmaceutical Group is not only reflected in the advance cognition and early warning of the change of relevant national regulations, but also runs through all links of the production process. The best proof is that more than 100 QC teams active in the production line carry out quality and technical breakthroughs around the problems all the year round.

At present, Yangzijiang Pharmaceutical Group has obvious competitive advantages in the traditional Chinese medicine varieties represented by Lanqin oral liquid, Suhuang cough capsules and Weisu granules, which have been exported to more than 10 countries and regions such as Russia and Thailand. By the end of 2019, 7 varieties of Yangzijiang Pharmaceutical Group have obtained EU GMP certification.

Implement lean quality management to achieve high quality and efficient production

The quality and safety of drugs are not only related to the health and quality of life of patients, but also closely related to the happiness of a family. Because of this, Yangzijiang Pharmaceutical Group has always taken quality and safety as the bottom line and red line that can not be touched, and formulated the quality spirit of "any difficulties can not beat us down, only quality". As the head of the company Xu Jingren is to use various opportunities and occasions to repeatedly emphasize this spirit, and all-round implementation.

To ensure the quality and safety of drugs, in addition to emphasizing cognition from the perspective of consciousness, there must be a good management system to support and guarantee, so there is a drug quality risk control mode with the mission of "seeking, forging ahead and protecting all sentient beings". When entering the production workshop of Yangzijiang Pharmaceutical Group, the control mode is not only reflected in the publicity board, but also in every link of the production process. It covers six basic elements: people (staff), machine (equipment), material (raw material), method (operating rules), environment (environment) and measurement (detection), with only one purpose. Let every pill (vial) that goes to market meet the standards and be safe. For Yangzijiang Pharmaceutical Group, the road of quality improvement is endless. In addition, the market development environment is constantly changing, and there is still room for continuous improvement of quality management methods and means. Based on this, the company put forward the concept of lean quality management, and vigorously implemented from the second half of this year.

Xu Kaixiang said that lean quality management is a higher management measure introduced by the company based on the current stricter drug regulation, generic drug quality and efficacy consistency evaluation, as well as new changes and challenges such as drug volume procurement, aiming to achieve high quality, low cost and high efficiency in drug production.

According to introducing, the Yangtze river pharmaceutical group is pushing lean quality management, refer to the quality characteristics of the FDA, and some of the internal quality system evaluation index, the multinational pharmaceutical companies set up four evaluation index of the target value, the product quality of complaints, the general is invalid OOS rate (OOS is refers to the laboratory test results beyond the prescribed standards, OOS invalid is defined as an out-of-specification test result due to laboratory reasons other than a material or product problem. The total invalid OOS rate refers to the percentage of the total invalid OOS in the total OOS in the laboratory. The index reflects the testing technology and management level of the laboratory to some extent. , the rate of OOS failure in finished product and long-term stability tests (the percentage of OOS failure in finished product release tests and long-term stability inspection tests accounted for the total number of OOS failure in finished product release tests and long-term stability inspection tests) and the closed loop rate of deviation, as well as 11 indicators to be improved. That is, batch acceptance rate, timely complaint handling rate, timely completion rate of stability test and timely completion rate of annual product review, etc.

"To achieve these goals, we can start from a quality cost management, including the prevention cost, inspection cost and the loss of internal and external costs, enhance risk awareness, reduce caused by unqualified personnel, material and customer complaint to solve, such as waste, through the process optimization and the use of advanced quality management tools, and repetitive problem solution formulation, etc., Significantly improve production efficiency and ensure quality." Xu Kaixiang added.

Xu Jingren believes that lean quality management and drug quality risk control mode complement each other, firmly holding the door of safe and high-quality production of the company, and further enhancing the competitiveness of the company and the strength of expanding the international market.

In the process of carrying out lean management, Yangzijiang Pharmaceutical Group continuously reduces the probability of producing unqualified products in the production process and the problem of low efficiency caused by personnel testing by using a large number of automated and intelligent equipment with online monitoring function. At the same time, we should focus on solving repetitive problems, strengthen tackling key problems, share experience and reduce unnecessary expenses.

At the beginning of 2019, a difficult problem of "drug selection", which had troubled Yangzijiang Pharmaceutical Group for many years, was solved by Wang Wei, deputy director of Solid Preparation No.3 Workshop of the company. The original company in the production of roxithromycin capsules, because of the powder is relatively fine, the machine will fill the appearance of defects, has been through the manual "drug selection"

At present, Yangzijiang pharmaceutical group is still actively at the present stage of the appearance of defective products to carry out technical breakthroughs. Since July, we have re-classified the reasons for the rejected unqualified products in the production process, and taken measures such as moving forward the gate to reduce the quality risk and cost loss, so as to continuously improve the quality of products. In addition, by reducing unnecessary stability tests of finished products, and sorting out and optimizing records filled in by employees, the company has continuously reduced costs and improved benefits.

Because of its dedication to quality and safety, Yangzijiang Pharmaceutical Group has not only established its position as a leading enterprise in the industry, but also become increasingly competitive. Taking the consistency evaluation of generic drug quality and curative effect as an example, up to now, the company has passed or deemed to have passed the consistency evaluation of 30 varieties and 36 specifications, among which 15 varieties are the first to pass the consistency evaluation in China and are in the leading position in the industry. In 2015, Ginkgo biloba extract and Ginkgo biloba leaf were both the first in the country to pass the EU GMP certification, which laid a foundation for the products to open the EU market.

In recent years, Yangzijiang Pharmaceutical Group has been striving for the China Quality Award, in order to achieve better management, more efficient and safe production. This year, the company will strive for the European quality award on the agenda, in order to improve the quality management level, enhance the company's global brand image, and help the drug market in Europe and the United States.

Reprinted from A04, China Quality News, July 17, 2020

http://epaper.cqn.com.cn/article/490793.html