Streamlined Shipment Inspections
at Otsuka Pharma
NTT DATA supports Otsuka Pharmaceutical Factories through Pharmaceutical Product Shipment Inspection Process
NTT DATA has developed a system to support the pharmaceutical product shipment inspection process at Otsuka Pharmaceutical Co., Ltd. Starting from April 2023, this system will be fully operational at all six domestic pharmaceutical manufacturing plants, helping reduce the time spent on manual data collection tasks.
This system aligns with the revised pharmaceutical regulations issued in August 2021, aiming to meet the high-quality assurance standards for pharmaceutical manufacturing. Leveraging the integrated platform "ServiceNow®," it integrates multiple internal IT systems to centrally manage various event information that affects product quality, such as manufacturing records and quality test results associated with batches of shipment-inspected products.
Previously, Otsuka Pharmaceutical's quality assurance department, who was responsible for shipment inspection, had to manually investigate and verify over 90 pieces of information from various systems and records managed by multiple departments, including factories and manufacturing management. Now that the necessary information for shipment inspection is consolidated into a single system, it will reduce the burden of complex verification tasks, prevent human errors, and ensure more reliable shipment of pharmaceutical products.
NTT DATA plans to further enhance the functionality of this system in the future, contributing to increased efficiency and reliability in the pharmaceutical industry.
Background of Needs
Pharmaceutical companies ensure the quality, effectiveness, and safety of medicines to provide better healthcare to medical facilities and patients. Therefore, the Quality Assurance department reviews records related to manufacturing and testing, meticulously examines deviations and change management processes, and ensures that quality is maintained wholistically. This process is crucial for delivering safe and reliable products to the market and involves determining the release suitability of pharmaceuticals from raw material manufacturing, formulation manufacturing, and final packaging products, while also maintaining quality assurance information. In particular, manufacturing records and quality test records undergo thorough checks against dozens of criteria, not only to verify the results, but also to ensure data reliability. Additionally, investigations are conducted into any deviations or change management that may affect shipped products. Moreover, confirmation that the proper measures were taken is essential when such impacts exist. As the number of products increases, managing these aspects becomes more complex.
Furthermore, in August 2021, the GMP regulations were revised for the first time in 16 years, with specific references to the responsibilities of management, the tasks of the quality assurance department, shipping management from manufacturing sites, data integrity, and change/deviation management. As a result, the establishment of a "practical pharmaceutical quality system" became necessary to manage pharmaceutical manufacturing and quality control. Quality assurance in the pharmaceutical industry is now required to meet even higher standards due to these revised GMP regulations and the expansion into the global market also necessitates compliance with international regulations.
Our Solution Overview
In response to these challenges, NTT DATA, in collaboration with Otsuka Pharmaceutical, has developed a computerized system*1 to streamline the workload of product release assessments and ensure higher levels of quality assurance.
This system integrates multiple internal IT systems and serves as a centralized platform for managing various aspects related to product release assessments, including manufacturing records, quality test inspection results, as well as deviation management and change management, and OOS (Out of Specification) data. By implementing this system, the reliability of verification tasks in product release assessments has been improved, and the efficiency of information collection through centralized management has been achieved. Not only can necessary information be quickly searched and accessed, but also personnel involved in various tasks related to product release assessments can access the same platform. This enables cross-departmental tasks to be completed through the platform. Furthermore, by aggregating related information on product release assessments, it allows for end-to-end operations, enhancing transparency in the manufacturing process and contributing to the prevention of human errors by moving away from manual work.
Otsuka Pharmaceutical has introduced this system in all six of its domestic pharmaceutical manufacturing facilities, commencing full-scale operation for product-related release assessment tasks in April 2023.
- *1 We define the term "computerized system" as an integration of both the computer system and the business processes. This computerized system undergoes Computer System Validation (CSV) in accordance with the GMP regulations to ensure the quality assurance of pharmaceutical products and related items.
Prospects
Through the shipment inspection support system introduced here, NTT DATA will provide a service via the cloud with essential functionalities required for assisting pharmaceutical companies in their shipment inspection processes. This system aims to enhance the certainty of quality assurance, improve operational efficiency, ensure transparency in the pharmaceutical manufacturing process, and ultimately deliver reliable pharmaceuticals to healthcare institutions and patients. By addressing similar challenges faced by pharmaceutical companies, NTT DATA intends to contribute to overall industry efficiency and the secure distribution of pharmaceutical products.