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Data Integrity Evolves

LOGFILE 22/2018 – June 2018


Dear Colleague,

Hopefully you shall have done your homework in data integrity when the inspector knocks on your door! Some of the key questions you'd better have an answer to are: What are the current regulatory expectations? How do you ensure the reliability of your suppliers? Do you understand the impact of culture on your organisation?

In today’s feature, Thomas Peither provides you with exclusive insights into the discussions on data integrity from the recent ISPE European Annual Meeting. Regulators from three EU countries were actively involved in the session on data integrity. Don't miss out on this update!

Sabine Paris


Data Integrity and the Problem of Getting It Done

Data integrity: Learn more about the current discussions and regulatory expectations in today’s feature. Thomas Peither gives you exclusive insights from the ISPE European Annual Meeting 2018.

Over the last few weeks Thomas has summed up the highlights from the Pharma 4.0  (LOGFILE 16/2018) and Annex 1 sessions (LOGFILE 18/2018). This text (and many more) was also published in his live reporting from the conference on Linkedin (#gmppublishing).

>>> Read now: Data Integrity and the Problem of Getting It Done


Implementing and Monitoring Data Integrity Measures

To comply with the requirements of data integrity, suitable monitoring systems must be in place. In addition, regular personnel training on the importance of data integrity principles must be carried out.

You’ll understand all the requirements with Data Integrity in the EU: Requirements for Quality Management Systems. This report details the ins and outs of all three documents and explains how the FDA regulations fit in.

You will learn:

  • The five principles of data integrity
  • Differences between EU and UK
  • definitions of data integrity and raw data
  • Laboratory handling and testing of samples
  • and much more

The report also includes the texts for:

  • EMA’s question-and-answer document on data integrity
  • MHRA’s GXP data integrity guidance
  • WHO’s Annex 5: Guidance on Good Data and Record Management Practices.
>>> More information and order: Data Integrity in the EU



The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period. The revision is focused on an error correction in the calculation of the Cadmium inhalation Permitted Daily Exposure (PDE) level.

EU/US: MRA on Inspections – Lithuania and Ireland Added and Q&A Published
The US Food and Drug Administration (FDA) confirmed the capability of Lithuania and Ireland to carry out GMP inspections at a level equivalent to the US.
Read more ...


GMP Question of the Week

Why should SOPs have a uniform structure?

>>> Click here to read the answer


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