News about GMP/cGMP


WHO: Draft Guideline on Data Integrity

In late October 2019, the WHO published a 28-page draft guideline on data integrity. It clarifies basic aspects to ensure reliable data and information in the manufacture and control of medicinal products. A 7-page annex provides additional examples for the practical implementation of the requirements.

The document has been harmonised with existing DI guidelines, e. g. the US FDA, as far as possible. Similar to the FDA, the WHO continues to observe increasing numbers of data integrity violations and took this as an opportunity to develop its own guideline on the topic.

“Possible causes for this may include (i) too much reliance on human practices; (ii) the use of computerized systems that are not appropriately managed and validated; and (iii) failure to adequately review and manage original data and records,”

the guideline says.
The structure of the guideline is clear and straightforward:

  • Principles of data integrity and good documentation practices
  • Quality risk management
  • Management review
  • Outsourcing
  • Training
  • Data
  • Data integrity
  • Good documentation practice
  • Computerized systems
  • Corrective and preventive actions
  • References
  • Appendix 1 Examples of data integrity management

In terms of content, the wheel might not be reinvented in this draft, but a clear structure and language speak for the document. The examples of quality risk management and data integrity assessments are well worth mentioning, as well as the ten examples of good documentation practices in data integrity.

The comment period will be open until 15 January 2020. The rest of the timetable foresees processing the feedback by May 2020. However, a final version is not to be expected before the end of next year. 


WHO: Guideline on Data Integrity, draft