Quality Committee DI (Data Integrity) related deliverables
In response to the growing interest in data integrity (DI) in recent years, the GMP Subcommittee has launched the DI Project, which aims to develop an accurate understanding of the requirements of the latest guidelines on DI and to develop a DI response based on risk analysis, which is considered extremely important for the establishment of an effective and efficient quality assurance system. However, the requirements for DI are not always clear, and many pharmaceutical companies are still struggling to meet them. Therefore, in this project, we have created several examples of practical tools to assist in DI activities. The deliverables are examples, and a one-size-fits-all response according to these examples may not always be effective or efficient, but we hope that you will use these deliverables as a reference for risk-based DI responses tailored to the situation at each manufacturing facility, and edit them accordingly. (Printing and downloading are also available.)
- (Japanese version) DI Master Plan (821KB)
- (English version) DI Master Plan (113KB)
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An example of a master plan for establishing a DI management system at a manufacturing facility.
- (Japanese version) DI Compliance Assessment Sheet (596KB)
- (English version) DI Compliance Assessment Sheet (411KB)
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Assessment sheet to evaluate procedures and operations to ensure the governance of DI and the control and integrity of data and other information in a manufacturing facility.
Assessment tools for laboratory equipment and systems
First, the importance of each device/system is determined according to the Decision Tree. (2) After that, the DI risk (severity, probability of occurrence, and detectability) for each device/system is evaluated (risk scoring), and the tool is used to determine whether or not to respond and to prioritize the response.
Education and Training Materials
The PIC/S DI guidance (Good Practices for Data Management and Integrity in Regulated Systems) is a tool for assessing and prioritizing the risk of DI for each device and system (severity, probability of occurrence, and detection) and then evaluating whether or not to take action. Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 3)), which was interpreted by the GMP Subcommittee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and an education and training material consisting of slides and manuscript (notes) was developed.