Data Integrity (DI) has been an issue in Japan as it has been internationally, and many companies have established SOPs specific to DI. DI is very briefly described in three guidances in Japan, which are:
- Article 20 of Revised GMP Official Notification 2021
- Item GMP 20-13 of GMP Case Studies 2022
- Chapter 2 Item2-1 Legal Compliance for Pharmaceutical Manufacturers Official Notification 2021
The Data Integrity provisions include:
- DI must be assured and records continuously controlled.
- Records must include an audit trail as written in PIC/S DI guide, and record integrity must be assured.
- Record contents must be appropriately and accurately recorded.
At a 2024 Round Table Discussion event, members of Japan’s PMDA, industry associations and pharmaceutical companies gathered to freely discuss a variety of issues, including Data Integrity.
One member of the PMDA authority suggested that the important issues of DI are:
- Education
- Systemization
- Inspection
- Leadership of DI managers
- Commitment of senior management
Meanwhile, the US FDA has issued its latest DI guide in the form of a Q&A document, expanding upon the provisions of its earlier 2018 Data Integrity Guidance.
The EU and PIC/S published a DI guide in 2021 to accomplish DI in a systematic approach.
When considering the above situation, DI must be tackled by each organization for itself, in a balanced and appropriate way.
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