HIPPOCRATES

Zhejiang Gaozhi Pharmaceutical's Entrusted Production Quality Management Collaboration (OWL MAH) Project

I. Case Overview

Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd. is a professional pharmaceutical marketing authorization holding enterprise integrating "R&D, production, and sales". Since its establishment, Gaozhi Pharmaceutical has established and operated a relatively complete quality management system, covering pharmaceutical R&D, production supervision, and sales. In 2022, Gaozhi Pharmaceutical chose to implement Singdi’s "Entrusted Production Quality Management Collaboration Solution" (referred to as "Aomai™, OWL MAH™"). Currently, it has completed the first-phase construction (including document management, training management, and electronic contracts) and the second-phase construction centered on quality release management. Through the implementation of the two phases, the project has ensured the highly shared and timely transmission of quality documents, relevant records, and reports between Gaozhi Pharmaceutical and its entrusted manufacturers, simplified and accelerated the approval and release processes for Gaozhi Pharmaceutical (as the holder) and the entrusted production enterprises. It has effectively ensured the smooth connection of quality management systems between Gaozhi Pharmaceutical and the entrusted production enterprises, and improved the holder’s quality management level in pharmaceutical entrusted production.

II. Project Background

Gaozhi Pharmaceutical obtained the Pharmaceutical Production License in August 2021 and passed the Good Manufacturing Practice (GMP) compliance inspection in December 2021. Under the national regulatory requirement that marketing authorization holder (MAH) enterprises shall assume the role of "main responsibility subject", Gaozhi Pharmaceutical has been exploring digital means to achieve the collaboration of quality management systems with its entrusted production enterprises in multiple locations, thereby effectively controlling risks related to product safety, efficacy, and quality controllability.

III. Specific Measures

(I) Overall Planning

Gaozhi Pharmaceutical’s OWL MAH collaboration management project is divided into four phases. Through the implementation strategy of "overall planning and phased implementation", the project will ultimately achieve the following goals: establishing a basic quality assurance system that meets regulatory requirements, building a communication and collaboration mechanism between Gaozhi Pharmaceutical and its entrusted enterprises, and digitalizing employee qualifications and organizational structures. The four-phase implementation can effectively ensure Gaozhi Pharmaceutical (as the MAH enterprise) to control quality risks of the entrusted production enterprises.

(II) Business Model

By leveraging a digital technology platform, the OWL MAH project has established a comprehensive and efficient quality assurance system for Gaozhi Pharmaceutical to meet pharmaceutical regulatory requirements and ensure pharmaceutical quality and safety. In each phase of the project implementation, collaborative work is carried out for different management fields to improve the efficiency and quality control of the entire supply chain. This model helps Gaozhi Pharmaceutical (as the holder) better manage its pharmaceutical production and quality assurance processes while establishing a close cooperative relationship with the entrusted production enterprises.

(III) Technical Architecture

The Pharmaceutical Entrusted Production Quality Management Collaboration Solution (OWL MAH) is one of the core solutions based on Singdi’s Aotai Digital Platform. Aotai is a digital platform jointly developed by Singdi’s industry experts and IT experts. With "quality compliance expert" as its management concept and market positioning, it helps enterprises improve their quality compliance level, meet industry supervision requirements, enhance enterprise management capabilities, and accelerate the launch of more safe, effective, and high-quality products.

The applications on the Aotai Platform can be customized to meet the specific needs of enterprises for quality systems. The built-in configurable tools cover 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 needs.

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 effective manner, and the distributed architecture is optimized for server expansion;
Standard Application Programming Interfaces (APIs) greatly improve system access efficiency, including: automatic email notifications, SMS notifications, and dashboard alerts integrated into workflows, which significantly reduce the risk of missing tasks or approvals;
The background task submission and management mode supports users to perform other tasks simultaneously;
A standard intermediate 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 Gaozhi Pharmaceutical’s OWL MAH project was 10 months. The finally implemented functions include major modules such as organization and personnel management, document and training management, record and release management, pharmacovigilance, and quality assurance and control. Among them, quality management covers modules including supplier management, deviation management, out-of-specification (OOX) management, Corrective and Preventive Actions (CAPA) management, change management, audit (self-inspection) management, validation management, complaint management, recall management, and risk management. The comparison of economic benefits after the project is as follows:

【Comprehensive Labor Efficiency Improvement】

Real-time, accurate, and reliable data statistics, with a speed increased by 80%;
Personnel recruitment reduced by approximately 20%, and the effect will become more significant as the number of users gradually covers all staff;
After the implementation of online release management, the release speed has increased by at least 40%.

【Quality Improvement】

The informatization traceability of product quality has reached over 90%;
The consistency and integrity of data have been strengthened by 100%;
Online monitoring and real-time early warning have improved online quality control by an average of 10-30%;
The efficiency of Product Quality Review (PQR) analysis has increased by more than 20%.

【Error Reduction】

Statistical errors eliminated by over 90%;
Human errors eliminated by over 80%.

(II) Social Achievements

Since the National Medical Products Administration (NMPA) issued the "Announcement on Strengthening the Supervision and Administration of Entrusted Production by Marketing Authorization Holders of Drugs (No. 132 of 2023)" on October 23, 2023, drug regulatory personnel in various provinces have also tightened the licensing requirements for "Category B Certificates" (for MAHs without production facilities) in line with the relevant documents during on-site inspections. The scope and intensity of supervision have also been enhanced. Compared with the "boom" of Category B Certificate enterprises from 2020 to 2023, the number of approved and issued "Pharmaceutical Production Licenses" (Category B) for entrusted production enterprises in various provinces has decreased significantly. From a policy perspective, the NMPA is continuously strengthening the supervision of MAHs engaged in entrusted production, requiring MAHs of entrusted production drugs to conduct quality management and monitoring throughout the entire pharmaceutical life cycle.

Hippocrates’s Entrusted Production Quality Management Collaboration Solution (OWL MAH) is fully compliant with the regulatory requirements of China’s MAH system. It provides MAH enterprises with a comprehensive entrusted production quality management collaboration solution, ensuring that quality documents, relevant records, and reports are highly shared, timely transmitted, and effectively stored between MAHs and their entrusted parties. It simplifies and accelerates the approval and release processes between MAHs and entrusted production enterprises, ensures the effective and close connection of quality management systems between MAHs and entrusted enterprises, thereby enabling MAHs to fulfill their corresponding responsibilities in the quality management of entrusted pharmaceutical production and ensuring the safety, efficacy, and quality controllability of entrusted production drugs.

By implementing Hippocrates’s OWL MAH solution, Gaozhi Pharmaceutical has established a comprehensive quality management collaboration system, ensuring that pharmaceutical production meets regulatory requirements, solving key issues in entrusted production quality management, and achieving good economic benefits. The Gaozhi case provides a new idea for many MAH enterprises on how to improve their quality compliance management level through digital means.

V. Relevant Solutions

Solution 1: Pharmaceutical Entrusted Production Quality Management Collaboration Solution (OWL MAH)
Solution 2: GMP Quality Compliance Digital Solution (QCMS)

VI. Relevant Cases

Case 1: Kobayashi Pharmaceutical’s Entrusted Production Quality Management Collaboration (OWL MAH) Project
Case 2: Zhejiang Zhenyuan Pharmaceutical’s GMP Quality Compliance Digital (QCMS) Project
Case 3: Suzhou Fushilai Pharmaceutical’s GMP Training Management (TMS) Project