Data Integrity - two new documents from PIC/S and EMA

In the last two years, national competent authorities from all over the world have focused more and more on Data Integrity. Many draft guidances from different authorities were published in 2016. In April 2016, the American FDA issued a first draft Guidance for Industry - "New FDA Draft Guidance Data Integrity and Compliance with cGMP" -  and in July 2016, the British MHRA issued a third draft - " MHRA GxP Data Integrity Definitions and Guidance for Industry - Draft version for consultation". On 10 August 2016, the PIC/S followed with a first draft "Good Practices for Data Management and Integrity in regulated GMP/GDP environments" and simultaneously the European Medicines Agency (EMA) extended their 'Questions and answers: Good Manufacturing Practices' webpage by 23 answers on Data Integrity questions.

PIC/S 041-1 "Good Practices for Data Management and Integrity in regulated GMP/GDP environments"

The current PIC/S draft document PI 041-1 contains 41 pages of detailed information. The document was written to provide guidance for inspectorates. The comment period for PIC/S Participating Authorities will end on 28 February 2017. The following activities have not been defined yet.

The introduction referred to the fact that the effectiveness of inspection processes is determined by the veracity of the evidence provided to the inspector and ultimately the integrity of the underlying data. Furthermore it is critical to the inspection process that inspectors can determine and, fully rely on the accuracy and completeness of evidence and records presented to them. Therefore Good Data Management practices influence the integrity of all data generated and recorded by a manufacturer and these practices should ensure that data is accurate, complete and reliable.

The first third of the document introduces 3 basic principles:

  • Data governance system 
  • Organisational influences on successful data integrity management
  • General data integrity principles and enablers

The main part of the document focuses on the topics "Specific DI considerations for paper-based systems" and "Specific data integrity considerations for computerised systems". Here you can find the expectations of inspectors for different items. Each item will discussed in relation to "potential risk of not meeting expectations / items to be checked".

At the end of the document you will find 4 additional chapters on

  • Data integrity considerations for outsourced activities
  • Regulatory actions in response to data integrity findings
  • Remediation of data integrity failures
  • Definitions

EMA Questions and answers: Good Manufacturing Practice

For many years, the European Medicines Agency (EMA) has been publishing a list of answers to frequently asked questions regarding Good Manufacturing Practice. The answers were discussed and agreed by the 'Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group. Therefore the answers could be interpreted as an official EU statement to open GMP questions. Basically the answers are given to questions in relation to different chapters and annexes of the EU GMP guide. Furthermore there will be answers to topics like 'general GMP', 'GMP certificates' and 'inspection coordination'. On 10 August 2016, the EMA extended the list by detailed answers on 23 questions to Data Integrity, Data Lifecycle and related topics.


PIC/S PI 041-1 "Good Practices for Data Management and Integrity in regulated GMP/GDP environments"

EMA Questions and answers: Good Manufacturing Practice

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