PIC/S gives ECA the Opportunity to comment on PI 041-1 (Draft 3) - Data Integrity

Pharmaceutical inspectors from more than 50 countries have joined the Pharmaceutical Inspection Co-operation Scheme by now. One of the main objectives of the PIC/S is developing harmonised GMP/GDP guidelines. The PIC/S provides guidelines - PIxxx- for its inspectors which are aimed to support them in the course of inspections. These documents are publicly available and present possible questions arising during authority inspections.

The PIC/S is currently working on the elaboration of guidance PI 041-1 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments". The second draft of the document was originally published on 10 August 2016 and released for discussion. The extensive internal comments have been consolidated by the PIC/S and resulted in a revised third draft. This third draft was published on 30 November 2018.  

In addition to other organisations, the ECA has been invited to comment this new draft. For that purpose you will find a PDF comparing Draft 2 and 3 and the template for your comments in the ECA website members' area. For more information on the new PIC/S guidance draft please see the PIC/S website.

For your information here are the contents and the main changes of the third draft of PIC/S PI 041-1:

  • The document's basic structure (made of 14 chapters) has been maintained.

             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 issues
            13. Definitions
            14. Revision history 

  • Subchapter 8.9 "Maintaining records" has been removed.
  • A new subchapter 9.8 "Management of Hybrid Systems" has been added.
  • Significant and comprehensive extensions have been made to the subchapters 9.3 "System security for computerised systems" and 9.4 "Audit trails for computerised systems".
  • A document comparison between the second and the third draft is available in the Members' Area of the ECA Data Integrity & IT Compliance Group.

The ECA will also dedicate a specific workshop to the new Draft 3 on 19/20 February 2019 in Berlin and invites stakeholders to participate in commenting on the document. The programme will be available in week 50/51 - details will follow.

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