Zhejiang Zhenyuan Pharmaceutical GMP Quality Compliance Digitalization (QMS) Project

I. Case Overview

Zhejiang Zhenyuan Pharmaceutical Co., Ltd. (Stock Code: 000705) is a national key high-tech enterprise. The company has seven active pharmaceutical ingredient (API) workshops and two formulation workshops. In 2021, Zhenyuan Pharmaceutical chose to implement Xingdi’s GMP Quality Compliance Management System (Quality Management System, QMS), and completed the construction of a quality system covering document management, training, and quality control.

Through the project implementation, the authenticity, reliability, and traceability of business data have been ensured, and a sound quality compliance system has been established. This system guarantees the high-level sharing and timely transmission of quality documents, relevant records, and reports across all departments of the enterprise, simplifies and accelerates the processes of drug approval and release, effectively improves Zhenyuan Pharmaceutical’s GMP management level, and ensures that the company’s GMP-compliant production meets domestic and international regulatory requirements.

II. Project Background

Zhenyuan Pharmaceutical possesses comprehensive production capabilities, including API production via chemical synthesis and biological fermentation, as well as the production of oral solid formulations and small-volume injections. It has established a sound product quality management system, and some of its products have undergone and passed certifications such as FDA (U.S. Food and Drug Administration) inspection and German GMP certification.

To adapt to the digital development trend of domestic and international pharmaceutical enterprises, ensure the authenticity, reliability, and traceability of data, and establish a sound compliance and quality management system, Zhenyuan Pharmaceutical aimed to use digital means to ensure its GMP-compliant production meets domestic and overseas regulatory requirements, thereby enhancing the overall GMP management level of the enterprise.

III. Specific Measures

(I) Overall Planning

Zhenyuan Pharmaceutical’s GMP Quality Compliance Digitalization Project (QMS) was divided into four phases and ultimately completed through the implementation strategy of “overall planning and phased implementation”. The project achieved the following goals: building a basic quality assurance system that meets regulatory requirements, establishing a communication and collaboration mechanism among various departments, realizing the digitalization of employee qualifications and organizational structure, and finally completing the full-lifecycle quality management of pharmaceuticals while ensuring the company’s quality system fully complies with domestic and overseas regulatory requirements.

(II) Business Model

Zhenyuan Pharmaceutical’s GMP Quality Compliance Digitalization Project (QMS) consisted of four phases:

1. The first phase focused on digital transformation planning, where the overall implementation path of the project was determined by researching the digital construction of domestic and international benchmarking enterprises;
2. The second phase established a basic quality assurance system by implementing document and training management;
3. The third phase completed the construction of quality management, covering deviation management, change management, audit management, and supplier management;
4. The fourth phase implemented business intelligence to provide comprehensive decision-making support for the enterprise.

(III) Technical Architecture

The GMP Quality Compliance Digitalization Solution (QMS) is one of the core solutions on Xingdi’s Aotai Digital Platform. Aotai is a digital platform jointly developed by Xingdi’s industry experts and IT experts, with the management concept and market positioning of “Quality Compliance Expert”. It helps enterprises improve their quality compliance level, meet industry regulatory requirements, enhance enterprise management capabilities, and accelerate the launch of more safe, effective, and high-quality products.

The applications on the Aotai Platform can provide tailor-made quality systems according to enterprise needs. The built-in configuration tools already include multiple quality management functions, eliminating the need for customization or programming to implement certain special processes. Trained personnel can quickly customize forms, decision trees, and dashboards to meet specific business requirements.

The superior design of the Aotai Platform ensures that users can quickly access large volumes of records and data, thereby improving work efficiency. The “intelligent loading” of forms minimizes loading time; frequently used data is cached to maximize network bandwidth utilization; data is stored in an efficient manner, and the distributed architecture is optimized for server expansion.

The standard Application Programming Interfaces (APIs) significantly improve system access efficiency. Functions such as automatic email notifications, SMS notifications, and dashboard alerts are integrated into the workflow, greatly reducing the risk of missing tasks or approvals. The background task submission and management mode supports users to perform other tasks simultaneously. A standard middleware service layer is provided to support integration with any third-party system, facilitating data exchange between Aotai and other application systems.

IV. Construction Achievements

(I) Enterprise Achievements

The overall implementation cycle of Zhenyuan Pharmaceutical’s GMP Quality Compliance Digitalization Project was 6 months. The final implemented functions covered core modules including organizational and personnel management, document and training management, record and release management, and quality assurance and control. Among these, quality management further included modules such as supplier management, deviation management, out-of-specification (OOX) event management, CAPA (Corrective and Preventive Actions) management, change management, audit (self-inspection) management, validation management, complaint management, recall management, and risk management.

The comparative economic benefits after the project are as follows:

• Improvement in Comprehensive Labor Efficiency• Real-time, accurate, and reliable data statistics, with an 80% increase in speed;• Relevant statistical positions were eliminated. After the first phase of the project, staff recruitment decreased by approximately 20% compared with the pre-implementation period, and the effect will become more significant as the number of users of the project gradually covers the entire enterprise.
• Quality Improvement• Over 90% informatized traceability of product quality;• 100% enhancement in data consistency and integrity;• Real-time online monitoring and early warning, with an average 1-3% improvement in online quality control;• Over 20% increase in the efficiency of PQR (Product Quality Review) analysis.
• Error Reduction• Elimination of over 90% of statistical errors;• Elimination of over 80% of human errors.
• Efficiency Improvement in Document and Record Management• Optimized document conversion and approval processes, with an approximately 30% increase in approval speed;• Over 70% of batch production records, auxiliary records, and post-specific documents were digitized;• Approximately 80% reduction in costs for document/record printing and related consumables;• Over 50% reduction in time spent on filling out records and documents.
• Efficiency Improvement in Training• After shifting training and assessment online, the total time for training organization was reduced by approximately 60%;• At least 80% increase in the speed of training effect statistics;• Approximately 40% improvement in the effectiveness of post-specific training.

(II) Social Achievements

Quality is the lifeline of pharmaceutical enterprises and the cornerstone of their survival and development. Currently, more and more pharmaceutical enterprises are implementing digital quality compliance management systems to prevent and avoid quality and safety incidents, and digital management has become the mainstream trend in the development of pharmaceutical enterprises.

The fundamental reason for Zhenyuan Pharmaceutical to implement Xingdi’s GMP Quality Compliance Digitalization Solution (QMS) is to strictly control quality processes through the system and realize two-way (top-down and bottom-up) comprehensive supervision of the quality management system. The core functions of Xingdi’s QMS Solution include automation of quality incident management processes, real-time reporting of quality risk incidents, encrypted protection of enterprise core documents, and establishment of an enterprise standardized training system—all of which are important components of achieving high-standard quality management.

The implementation of the QMS Solution helps Zhenyuan Pharmaceutical’s managers gain control over quality incidents in business operations, minimize any potential issues that may lead to quality and safety accidents, establish a sound GMP system, ensure business operations comply with GMP standards, reduce human operational errors, and comprehensively improve the drug quality management level.

By implementing Hippocrates’s QMS Solution, Zhenyuan Pharmaceutical has effectively established a sound quality management system, ensured the compliance of drug production, and achieved significant economic benefits. Zhenyuan Pharmaceutical’s QMS implementation case provides a new idea for pharmaceutical enterprises on how to improve GMP management level through digital technology.

V. Related Solutions

1. GMP Quality Compliance Digitalization Solution (QMS)
2. GMP Training Management Solution (TMS) for Pharmaceutical Enterprises

VI. Related Cases

1. Shanghai Shenqi Medical GMP Quality Compliance Digitalization (QMS) Project
2. Kobayashi Pharmaceutical Entrusted Production Quality Management Collaboration (OWL MAH) Project
3. Suzhou Fushilai Pharmaceutical GMP Training Management (TMS) Project