Quality & Technology Committee DI (Data Integrity) related Publications

In response to growing interest in data integrity (DI) in recent years, GMP Expert Committee, a sub-committee of the Quality and Technology Committee, JPMA, launched a DI project.

To establish an effective and efficient quality assurance system, it is considered to be extremely important to understand the requirements of the latest DI guidelines appropriately and address such DI requirements based on risk analyses.

However, the requirements for DI are not always clear, and many pharmaceutical companies are experiencing difficulties in addressing them.

Given such circumstances, this project team has produced several practical tools that will assist in DI activities.

These files are just examples; so simply following these examples word for word may not be adequately effective and efficient. However, it may be advisable to edit and use these files appropriately as reference to a risk-based DI approach commensurate with the specific situation of each manufacturing site.(These files can be printed out or downloaded.)

DI Master Plan(113KB)

An example of master plan for constructing a DI control system at a manufacturing site.

It is beneficial to draw up a master plan for DI activities, because, generally, DI is an issue to be addressed at all sections of manufacturing site, and it is a long-term project.

DI Compliance Assessment Sheet(441KB)

An assessment sheet to evaluate procedures and operations to ensure both DI governance and data integrity at manufacturing sites.

Assessment tools for laboratory equipment and systems

①First, the importance of each equipment and system is determined in accordance with this decision tree. ②Then, DI risk (severity, occurrence probability, and detectability) for each piece of equipment or system is evaluated (risk score), and the necessity of determining priorities and taking action is determined by this tool.

Education and Training Materials

These tools are the "Education and Training Materials" about DI, that encourage each individual in the organization, including management personnel, to understand the importance of data quality and compliance. These materials can be used to build an appropriate DI governance system and an open organization.

These materials, consisting of slides and texts (Notes), were created in accordance with the understanding and interpretation by GMP Expert Committee on PIC/S DI Guidance, "Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 3))".