PIC/S publishes final Document on Data Integrity

Pharmaceutical inspectors from more than 50 countries have now joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S). One of the main goals of the PIC/S is the development of harmonized GMP/GDP guidelines. To its inspectors, the PIC/S provides Guidelines/ Guidances - PIxxx- which are intended to provide support to inspectors during inspections. These documents are publicly available and highlight potential issues for pharmaceutical manufacturers during regulatory inspections.

History of the Guidance PI 041

Currently, the PIC/S published the long-awaited Guidance PI 041-1 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments" on the topic of data integrity. Initially, the 2nd draft was published on August 10, 2016 and made available for internal discussion. The PIC/S consolidated the extensive internal comments and published a 3rd draft for public comment on November 30, 2018. The ECA also participated with a workshop in Berlin and developed extensive suggestions for improvement.

The current Guidance PI 041 - what changed?

The document's basic structure with 14 chapters has been retained:

             1. Document history
             2. Introduction
             3. Purpose
             4. Scope
             5. Data governance system
             6. Organisational influences on successful data integrity management
             7. General data integrity principles and enablers
             8. Specific data integrity considerations for paper-based systems
             9. Specific data integrity considerations for computerised systems
            10. Data integrity considerations for outsourced activities
            11. Regulatory actions in response to data integrity findings
            12. Remediation of data integrity failures
            13. Glossery
            14. Revision history

  • Subchapters have been slightly renamed and/or restructured 
  • 6.2 (Final) "Code of ethics and Policies" is now "Policies related to organisational values, quality, staff conduct and ethics" 
  • 8.10 (Draft) "True copies" has been integrated in chapter 7 (Final) 
  • 8.11 (Draft) "Limitations of remote review of summary reports" has been integrated in chapter 7 (Final)
  • 9.3 (Final) "Validation and Maintenance" has been removed from chapter 9.2 (Draft) "qualification and validation of computerised systems"  
  • 9.4 (Final) "Data Transfer" has been removed from chapter 9.2 (Draft) "qualification and validation of computerised systems"  
  • 13 (Draft) "Definitions" is now 13 (Final) "Glossary"

A more detailed analysis of the content changes will follow in another news soon.

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