It becomes necessary for pharmaceutical enterprises to make long-term strategic plans to deal with changes brought by policies after China’s proposal of the Made in China 2025 strategy. The intelligent manufacturing is not merely a great change to pharmaceutical enterprises, but also a process to analyze and look at the issues and intractable problems encountered in enterprises’ development.

What are the difficulties for pharmaceutical enterprises to achieve automation and informatization? How should Chinese pharmaceutical industry walk out own road of Industry 4.0?

Let’s listen to the ideas shared by pharmaceutical enterprises that have breakthroughs in intelligent manufacturing. The enterprise sharing this time is Shandong Shinva Medical Instrument Co., Ltd.

Company profile

As the first medical device manufacturer established by the Communist Party of China and Chinese People's Liberation Army in 1943, Shandong Shinva Medical Instrument Co., Ltd. successfully went public at Shanghai Stock Exchange (600587) in September 2002. With dozens of new products launched to the market every year, Shinva has possessed up to 14 China State-level New Products, and is the first enterprise that owns a "State-level Enterprise Technical Center" in the Chinese medical device industry.

Q&A

1. What corresponding strategic plans have you made in recent years since China’s proposal of the Made in China 2025 strategy?

Shinva has vigorously developed the automated and information-based pharmaceutical machinery and Equipment used in API manufacturing in recent years.

I. Form the R&D and production system of automated equipment classified by production of infusions, solid preparations, TCM preparations and blood products, and provide pharmaceutical enterprises with comprehensive and full services on equipment level from the two main directions of product type and product precision, to improve product precision and operation stability.

II. Recognize the current situation of automation construction of pharmaceutical enterprises, and make the part missed in previous enterprise automation the direction for new products and vigorous promotion.

III. Conduct layout of consulting services for new informatization products and intelligent plant construction, and establish a new independent plant to provide information products and services, with products including the ERP, WMS, MES and LIMS, etc. required by pharmaceutical enterprises.

IV. Integrate resources of each sector, fuse own automated equipment and information-based products, carry out practice in pharmaceutical enterprises, and construct the road of intelligent manufacturing together with them.

V. Business promotion: Provide consulting services for process R&D and process improvement, etc., and provide pharmaceutical enterprises with product test and R&D platform and relevant resources.

2. What intractable problems of the pharmaceutical industry do you think the intelligent plants could solve?

From bottom to top of architecture of intelligent manufacturing enterprises, the problems include:

Automation coverage of production equipment, operation stability of equipment, disunity of equipment data communication protocols, islands of equipment and system data, off-line quality control, interference of human factors in production, separation of intelligent system and automated equipment, absence of application of the new-generation IT, discrete procurement, plan, production, operation, sales and market information inside enterprise, failure to further optimize production and increase overall enterprise operation efficiency by using big data analysis.

All the above shall be overcome by pharmaceutical enterprises during constructing intelligent plants.

3. What is the biggest difficulty for the automatic and information-based transformation of plants? What are the solutions?

The automatic and information-based transformation of old plants will encounter some problems, and the big difficulties include: old equipment failing to provide data output, equipment communication protocols being varied, old plant construction failing to consider network construction, and personnel of pharmaceutical enterprises not having sufficient consciousness during information construction, etc.

During the process, pharmaceutical enterprises, information construction suppliers and equipment suppliers are required to strengthen communication and cooperation, and overcome the above one by one through equipment communication module transformation and selection of data acquisition system with strong compatibility, etc.

Pharmaceutical enterprises shall also have a clear understanding of themselves and define the transformation objectives, and suppliers shall specifically propose feasible schemes.

4. What are the new trends the pharmaceutical enterprises are concerned about?

I. New product R&D: this is the long-term guarantee for enterprise development.

II. Pharmaceutical enterprises have transformed from the original pursuing of products to pursuing of product quality, and have increasingly strong demand for high-end pharmaceutical equipment.

III. Regulatory compliance: Regulators’ normalization of pharmaceutical enterprises has changed from the original supervision of production environment and production conditions to the supervision and regulation of information of full lifecycles of pharmaceutical products, resulting in them to eagerly look for countermeasures.

IV. Market flexibility: Pharmaceutical enterprises have increasingly strong demand for the timeliness of market information feedback and flexible coping.

5. How should pharmaceutical equipment suppliers and pharmaceutical enterprises unify thought and cooperate closely to effectively implement the strategic plans?

I. Unify the understanding: Made in China 2025 is the future development direction of pharmaceutical enterprises, and pharmaceutical equipment suppliers and pharmaceutical enterprises shall realize the pharmaceutical process automation, informatization and intelligence are the general trend;

II. Pharmaceutical equipment manufacturers shall strengthen technology enhancement and increase equipment stability in the new situation, and pharmaceutical equipment suppliers shall improve automation level of production line and reduce man-made interference as needed by pharmaceutical enterprises;

III. Communicate and collaborate closely, to guarantee information integrators to be able to fast and conveniently access the data required.

6. Could you please describe the Made in China 2025 of pharmaceutical industry in your eyes?

I. To establish the R&D system or platform based on informatization integration, to improve the drug R&D level and speed. (modern R&D system)

II. To improve the automation, informatization and intelligence levels of pharmaceutical equipment and pharmaceutical process, to promote the intelligent manufacturing and intelligent plant construction. (production system)

III. To promote the information-based integration of each business system of enterprises, and establish a modern operation and management system. (operation and management system)

IV. To establish and improve the quality monitoring, management and tracing system for whole pharmaceutical production process, and establish a modern quality management system. (quality supervision system)

V. To adopt the new-generation IT, and explore and achieve the enterprise-wide information management and pharmaceutical product lifecycle quality monitoring and tracing. (comprehensive information sharing)

7. Why the production informatization will become the development trend of the global pharmaceutical industry in the next years?

The pharmaceutical industry characteristics, and pressure from regulations and markets decide that the production informatization construction will become the development trend of the global pharmaceutical industry.

The biggest characteristic of the pharmaceutical industry is the special emphasis on the compliance of each aspect of pharmaceutical production with GxP and pharmaceutical product quality control, however, the whole pharmaceutical production process of the current pharmaceutical industry has a large number of manual operations and links where quality is uncontrollable.

Regarding information construction and application, many pharmaceutical enterprises have some applications in enterprise management, however, the applications are not truly deeply integrated to each link of the production industry, and informatization and automation of enterprises are mostly separated.

In the future, enterprises shall, through implementing production informatization management system, achieve the true "deep integration of informatization and industrialization", optimized operation, control and management, optimization of composite indicators like "production, quality, cost, consumption and safety", and finally achieve the basic form of integrated automation, i.e., "ERP-MES-PCS" informatization structure of enterprises.