Kobayashi Pharmaceutical's Contract Manufacturing Quality Management Collaboration (OWL MAH) Project

I. Case Overview

Kobayashi Pharmaceutical (China) Co., Ltd. (hereinafter referred to as "Kobayashi China"), established in Shanghai on April 9, 2018, is a wholly-owned subsidiary of Kobayashi Pharmaceutical Co., Ltd. As a Type B Certificate enterprise with the core development strategy focusing on pharmaceutical and health products, Kobayashi China is a wholly foreign-owned subsidiary integrating production, sales, and R&D. Founded in 1886, Kobayashi Pharmaceutical Co., Ltd. is a 120-year-old enterprise specializing in product development, mainly engaged in the R&D, production, and sales of pharmaceuticals, medical devices, daily necessities, and food products. In 2023, Kobayashi China decided to implement Singedi's "Contract Manufacturing Quality Management Collaboration Solution" (hereinafter referred to as "OWL MAHTM"), and has currently completed the first-phase construction, covering document management, training management, and electronic contracts. Through the implementation of this phase, the high-degree sharing and timely transmission of quality documents, relevant records, and reports between Kobayashi China and its contract manufacturers (located in Anhui and Jiangsu Provinces) have been ensured, effectively connecting the quality management systems of Kobayashi China and the contract manufacturing enterprises, and improving the MAH's (Marketing Authorization Holder) quality management level for pharmaceutical contract manufacturing.

II. Project Background

Under China's regulatory requirement that MA enterprises (Marketing Authorization enterprises) shall assume the role of "main responsibility subject", Kobayashi China has been seeking digital solutions to achieve the collaboration of quality management systems with its contract manufacturing enterprises in multiple regions, thereby realizing effective risk control over product safety, efficacy, and quality controllability.

III. Specific Measures

(I) Overall Planning

Kobayashi China'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: build a basic quality assurance system that meets regulatory requirements, establish a communication and collaboration mechanism between Kobayashi China and contract manufacturing enterprises, realize the digitalization of employee qualifications and organizational structure, and finally complete the full-life-cycle quality management of pharmaceuticals. The four-phase implementation can effectively ensure that Kobayashi China, as an MA enterprise, exercises quality risk control over contract manufacturing enterprises.

(II) Business Model

By leveraging a digital technology platform, the OWL MAH project helps Kobayashi China establish a comprehensive and efficient quality assurance system to meet pharmaceutical regulatory requirements and ensure pharmaceutical quality and safety. During each phase of the project implementation, targeted efforts are made in different management fields, and collaborative work is carried out to improve the efficiency and quality control of the entire supply chain. This model enables Kobayashi China, as the MAH, to better manage its pharmaceutical production and quality assurance processes while establishing a close cooperative relationship with contract manufacturing enterprises.

(III) Technical Architecture

The Pharmaceutical Contract Manufacturing Quality Management Collaboration (OWL MAH) Solution is one of the core solutions on Singedi's Aotai Digital Platform. Aotai Digital Platform is a digital platform jointly developed by Singedi'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 regulatory requirements, enhance corporate 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 excellent 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. The standard APIs significantly improve system access efficiency, including: automatic email notifications, SMS notifications, and dashboard alerts integrated into workflows, which greatly 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 the Aotai Platform and other application systems.

IV. Construction Achievements

(I) Enterprise Achievements

The overall implementation cycle of Kobayashi China's OWL MAH project is 12 months, covering four implementation entities including Shanghai Kobayashi, Hefei Kobayashi, and Jiangsu Kobayashi. The finally implemented functions include major functional modules such as organization and personnel management, document and training management, record and release management, pharmacovigilance, and quality assurance and control. Among these, quality management further includes 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 comparison of economic benefits after the project is as follows:

【Efficiency Improvement in Document and Record Management】

• Optimized document conversion and approval processes, with approval speed increased by approximately 30%.
• Over 70% of batch production records, auxiliary records, and post-related documents have been digitized.
• Expenses on document/record printing and related consumables reduced by approximately 80%.
• Time spent on filling in records and documents saved by more than 50%.

【Efficiency Improvement in Training】

• Optimized document conversion and approval processes, with approval speed increased by approximately 30%.
• Over 70% of batch production records, auxiliary records, and post-related documents have been digitized.
• Expenses on document/record printing and related consumables reduced by approximately 80%.
• Time spent on filling in records and documents saved by more than 50%.

【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 Contract Manufacturing by Marketing Authorization Holders (MAHs) (No. 132 of 2023) on October 23, 2023, drug regulatory personnel in various provinces have been tightening the requirements for issuing Type B Certificates in line with the relevant document during on-site inspections for Type B Certificates, and the scope and intensity of supervision have also been enhanced. Compared with the "boom" of Type B Certificate enterprises from 2020 to 2023, the number of Drug Production License approvals and issuances for contract manufacturing enterprises in various provinces has decreased significantly. From a policy perspective, it is evident that the NMPA is continuously strengthening the supervision of MAHs engaging in contract manufacturing, requiring MAHs of contract-manufactured pharmaceuticals to conduct full-life-cycle quality management and monitoring of the contract-manufactured products.

Hippocrtaes's Contract Manufacturing Quality Management Collaboration Solution (OWL MAH) is fully compliant with the regulatory requirements of China's MAH system. It provides MAHs with a comprehensive contract manufacturing quality management collaboration solution, ensuring the high-degree sharing, timely transmission, and effective preservation of quality documents, relevant records, and reports between MAHs and their contract manufacturers. It simplifies and accelerates the approval and release processes between MAHs and contract manufacturing enterprises, ensures the effective and close connection of quality management systems between MAHs and contract manufacturers, thereby enabling MAHs to fulfill their corresponding responsibilities in pharmaceutical contract manufacturing quality management and ensuring the safety, efficacy, and quality controllability of contract-manufactured pharmaceuticals.

By implementing Hippocrtaes's OWL MAH Solution, Kobayashi China has established a sound quality management collaboration system, ensured that pharmaceutical production meets supervision requirements, solved key issues in contract manufacturing quality management, and achieved significant economic benefits. The Kobayashi China case provides a new idea for pharmaceutical enterprises on how to improve the quality compliance management level of MA enterprises through digital means.

V. Related Solutions

• Solution 1: Pharmaceutical Contract Manufacturing Quality Management Collaboration Solution (OWL MAH)
• Solution 2: GMP Quality Compliance Digital Solution (QCMS)

VI. Related Cases

• Case 1: Zhejiang Gaozhi Pharmaceutical Contract Manufacturing Quality Management Collaboration (OWL MAH) Project
• Case 2: Zhejiang Zhenyuan Pharmaceutical GMP Quality Compliance Digital (QCMS) Project
• Case 3: Suzhou Fushilai Pharmaceutical GMP Training Management (TMS) Project