HIPPOCRATES

GMP Training Management (TMS) Project of Shenzhen Shankang Pharmaceutical Technology

I. Shankang Pharmaceutical: An Explorer in the Field of Innovative Drugs

Since its establishment in 2017, Shenzhen Shankang Pharmaceutical Technology Co., Ltd. has rooted itself in the field of innovative drug R&D, focusing on the research, production, and sales of addiction treatment drugs. Based in Shenzhen, the company has gradually emerged in the industry by virtue of its unique technological advantages and R&D capabilities. Shankang Pharmaceutical has always taken addiction treatment drug R&D as its core business, with substantial investment particularly in the R&D of naltrexone implants. This product, designed to prevent relapse in patients with opioid addiction after detoxification, embodies the company’s profound aspirations in the field of addiction treatment.

Driven by continuous R&D investment and an innovative spirit, Shankang Pharmaceutical has achieved a series of remarkable phased results in addiction treatment drug R&D. The company’s R&D team has conducted in-depth exploration in areas such as drug delivery technology and drug formulation optimization, committed to providing more efficient, safe, and convenient treatment solutions for patients. Its rich pipeline of in-research products is not only expected to fill market gaps in relevant domestic fields but also bring new hope to global addiction treatment.

II. Background for Launching the GMP Training Management (TMS) Project

In the pharmaceutical industry, drug quality is crucial to patients’ lives and health, while production standards serve as the cornerstone of ensuring drug quality. As the state continuously strengthens supervision over the pharmaceutical industry, a series of stringent regulatory policies have been introduced, placing higher requirements on the quality management systems of pharmaceutical manufacturing enterprises. Enterprises must ensure that every link of the drug lifecycle—from R&D and production to sales—complies with the Good Manufacturing Practice (GMP). This is not only a responsibility to patients but also a necessary condition for the enterprise’s legal and compliant operation.

As an enterprise dedicated to innovative drug R&D and production, Shankang Pharmaceutical is fully aware of the great responsibility it bears. To meet regulatory requirements and enhance its competitiveness in the industry, launching the GMP Training Management (TMS) Project has become an inevitable choice. Through cooperation with Singdi, the establishment of a sound training management system can effectively standardize employees’ operational behaviors and improve their awareness and understanding of GMP, thereby ensuring that the company’s production and operations always adhere to high-standard quality management specifications.

III. Core Content and Features of the TMS Project

(I) Construction of a Comprehensive Training System

Shankang Pharmaceutical’s TMS Project has demonstrated great ingenuity in building a training system, fully considering the diverse needs of different positions and business links within the enterprise. From R&D personnel in the R&D department, frontline production operators, to quality control inspectors in the quality control department, each position is equipped with exclusive training courses tailored to its specific requirements.

For R&D personnel, the project focuses on providing training on cutting-edge theoretical knowledge of drug R&D, covering content such as the latest research on drug mechanisms of action and innovative drug design methods. This helps them keep pace with industry development trends and continuously improve their R&D capabilities. Meanwhile, practical training on Good Clinical Practice (GCP) is also provided, enabling R&D personnel to proficiently master all links of clinical trials and ensure the accuracy and reliability of research data.
Frontline production operators receive detailed training on drug production operation specifications, including the correct operation methods of equipment, strict control of production processes, and key points of quality control during production. Through practical training that simulates real production scenarios, operators can master operational skills proficiently in practice, thereby improving production efficiency and product quality.
Quality control inspectors participate in comprehensive training on quality testing standards and methods, learning to use various advanced testing technologies and instruments to ensure accurate and timely testing and evaluation of drug quality.
These training courses not only include rich theoretical knowledge but also attach special importance to the cultivation of practical operations. By simulating real work scenarios, employees can deepen their understanding and application of GMP standards in practice, effectively improving their practical operational capabilities and providing strong guarantees for drug quality and safety.

(II) Application of Advanced Technologies

To enhance training effectiveness and efficiency, the TMS Project has introduced a series of advanced digital technologies. The construction of an online learning platform provides employees with a convenient learning channel. Employees can log in to the platform to study anytime and anywhere according to their own schedules, breaking the limitations of time and space. The platform not only contains rich learning resources such as electronic documents and video tutorials but also sets up an interactive communication section, where employees can share learning experiences and exchange work insights, fostering a positive learning atmosphere.

The application of simulation training software adds a highlight to the training. This software can highly simulate various scenarios in the drug production process, including equipment failures, operational errors, and other emergency situations. Employees conduct operational exercises in a virtual environment—they can boldly try various operation methods without worrying about affecting actual production. In this way, employees can accumulate rich practical experience in a short period and improve their ability to respond to emergencies. At the same time, the software can conduct real-time evaluation and feedback on employees’ operation processes, helping them identify and improve problems in a timely manner.

In terms of technical support, the TMS Project is backed by Singdi’s professional technical team, which is responsible for the maintenance and upgrading of the platform to ensure its stable operation. Meanwhile, the technical team continuously optimizes the platform’s functions and learning resources based on employees’ feedback, so as to meet employees’ growing learning needs.

IV. Challenges and Countermeasures During the TMS Project Implementation

Shankang Pharmaceutical did not have a smooth journey during the implementation of the TMS Project; instead, it encountered many challenges.

Personnel coordination issues were the most prominent. Since the project involved multiple departments of the company, employees in different departments had different work rhythms and priorities, making it difficult to reach consensus on training schedule and participation. R&D personnel were often too busy with experiments and research tasks to attend training on time, while the production department also faced frequent conflicts in training time due to tight production schedules.
Technical challenges also posed a major obstacle to the project progress. In the initial operation stage, the online learning platform experienced problems such as lagging and slow loading, which affected employees’ learning experience. The simulation training software also needed improvement in terms of adaptability to actual production scenarios—some functions could not accurately simulate real production operations, resulting in a significant reduction in training effectiveness.
Time management was another challenge. The project implementation needed to be carried out without affecting the company’s normal production and operation, which placed extremely high requirements on the control of project progress. How to complete the platform construction, training course development, and employee training within a limited time became a problem that the project team had to solve.
In the face of these challenges, Shankang Pharmaceutical adopted a series of effective countermeasures:

To address personnel coordination issues, the company established a special project coordination team composed of heads of various departments. The team held regular meetings to communicate the work arrangements of each department and flexibly adjust the training plan according to the actual situation. For employees who really could not attend centralized training, personalized training plans were provided, such as arranging online self-directed learning or one-on-one tutoring during work breaks.
To solve technical challenges, Shankang Pharmaceutical increased technical investment and invited a professional technical team to optimize and upgrade the online learning platform. Through measures such as server expansion and code optimization, the problems of platform lagging and slow loading were effectively resolved. At the same time, close cooperation was carried out with the supplier of the simulation training software to conduct customized development of the software according to actual production needs, improving its adaptability to production scenarios.
In terms of time management, the project team formulated a detailed project schedule, dividing the project into multiple phases and tasks, and clarifying the time nodes and responsible persons for each task. The agile project management methodology was adopted to adjust the project plan in a timely manner, ensuring the project was completed on schedule.

V. Remarkable Results Brought by the TMS Project

(I) Internal Results

In terms of improving employees’ professional skills, the TMS Project has brought remarkable changes. By comparing the employee skill assessment data before and after the project implementation, it was found that the average score of employees has increased by 30%. This significant improvement strongly proves that after systematic training, employees have a more solid grasp of GMP knowledge and their professional skills have achieved a qualitative leap.

The optimization of production processes was also realized under the promotion of the TMS Project. The originally complex and cumbersome production processes were simplified and standardized after training. Employees have a clearer understanding of the production processes and more proficient operations, which has greatly improved production efficiency. For example, in a key link of drug production, the production time for a batch of products was reduced from 12 hours (before the project) to 8 hours (after the project), representing a 20% increase in production efficiency.

The improvement of product quality is another important achievement of the TMS Project. Through long-term monitoring and analysis of product quality data, it was found that the product qualification rate has increased from 85% (before the project) to 90% (after the project). This not only reduces losses caused by product quality problems but also further enhances the company’s reputation and competitiveness in the market.

(II) Industry Impact

Shankang Pharmaceutical’s TMS Project has important reference value in the pharmaceutical industry. Its innovative training management model provides a valuable reference example for other enterprises. Through the application of digital technology, it realizes efficient training management and personalized customization, offering new ideas and methods for enterprises in the industry to solve training problems.

In terms of quality control, the project has set a new benchmark. Through strict training and assessment, it ensures that employees strictly follow GMP standards during production, effectively improving product quality. This has prompted other enterprises in the industry to re-examine their own quality control systems, promoting the improvement of the overall quality level of the pharmaceutical industry.

VI. Future Outlook: Shankang Pharmaceutical’s Sustainable Development

Looking ahead, Shankang Pharmaceutical will continue to forge ahead in the field of innovative drug R&D and production, relying on the solid foundation laid by the TMS Project.

In R&D, the company plans to further increase investment in the R&D of addiction treatment drugs, continuously expand its product pipeline, and explore more potential therapeutic targets and drug dosage forms. Shankang Pharmaceutical will make full use of the advantages brought by the TMS Project—such as the improvement of employees’ professional skills and the optimization of production processes—to accelerate the pace of new drug R&D, improve the success rate of R&D, and strive to achieve more breakthrough results in the field of addiction treatment.
In the production link, the company will continuously optimize production processes to improve production efficiency and product quality. With the in-depth understanding and strict implementation of GMP standards by employees trained through the TMS Project, Shankang Pharmaceutical will ensure that every batch of products meets high-quality standards, providing safe and effective drugs for patients. At the same time, the company will actively introduce advanced production equipment and technologies to realize intelligent and automated production, further enhancing the enterprise’s competitiveness.
In market expansion, Shankang Pharmaceutical will take the domestic market as the foundation and gradually expand into the international market. The company will strengthen cooperation with domestic and foreign medical institutions and pharmaceutical enterprises to promote the market promotion and application of its products. With the improved corporate image and brand reputation brought by the TMS Project, Shankang Pharmaceutical is confident in gaining more market share in domestic and international markets and becoming a leading enterprise in the global addiction treatment field.

VII. Related Solutions

Solution 1: Hippocrates GMP Training Management System (TMS)
Solution 2: Hippocrates GMP Document Management System (DMS)

VIII. Related Cases

Case 1: GMP Training Management (TMS) Project of Suzhou Fushilai Pharmaceutical
Case 2: GMP Training Management (TMS) Project of Shijiazhuang Yiling Pharmaceutical