On 30 November 2018 PIC/S revised the current revision of PI 041-1 – DRAFT 3.

UPDATE 2021 – PIC/S PI 041 – Final Version – 1. July 2021

Here is the announcement from the PIC/S website (source)

Focused stakeholders consultation on revised draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

Geneva, 30 November 2018: a revised Draft PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 3)) has been prepared by the PIC/S Working Group on Data Integrity, co-led by Australia / TGA and UK / MHRA.

The purpose of the guidance is to serve to outline the position an inspector would adopt during the inspection of GDP/GMP facilities and is designed to facilitate a harmonised approach to the inspection, including reporting in regards to data management and integrity. A first draft (PI 041-1 (Draft 2)) was published by PIC/S on a trial basis in August 2016. Following feedback received from PIC/S Participating Authorities during its 6-month implementation trial-period, the draft of this guidance has been updated and expanded by the Working Group.

The document (PI 041-1 (Draft 3)) is subject to a focused stakeholder consultation seeking substantive comments from trade and professional associations on specific questions relating to the proportionality, clarity and implementation of the guidance requirements. In parallel to this stakeholder consultation, the new draft will be applied by PIC/S Participating Authorities on a trial basis for a new implementation trial period.

The consultation period will last 3 months and run from 30 November 2018 to 28 February 2019.

To submit feedback, please provide feedback exclusively on the dedicated template available on the websites of the below associations and submit by e-mail with subject line “PIC/S Focused Public Consultation – Data Management and Integrity” to one of the following associations which will collect and compile responses. Stakeholders should only reply once.

• ECA (European Compliance Academy) Foundation:
  send to: heimes@gmp-compliance.org
• IFPMA (International Federation of Pharmaceutical Manufacturers & Associations):
  send to: s.adam@ifpma.org
• ISPE (International Society for Pharmaceutical Engineering):
  send to: regulatorycomments@ispe.org
• PDA (Parenteral Drug Association):
  send to: tmorris@pda.org

To download the consultation document (PI 041-1 (Draft 3)) please consult the page “Publications” or click on the link below:

PI 041-1 (Draft 3) Guidance on Data Integrity.pdf

After the British agency MHRA has published three (3) different draft versions of the – MHRA GMP Data Integrity Definitions and Guidance for Industry – in January and March 2015 (GMP) and in July 2016 (Draft for consultation – now for GXP) the final  “Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions was published in March 2018.

Looking into the history of the document and content the major changes have been to replace and extend from “GMP” to GXP (covering  GCP, GDP, GLP, GMP and GPvP).  All this GXP areas had already requirements for data integrity or study integrity or similar for many years and are covered by European EMA regulations, directives and the EMA EudraLex Volumes or other regulations (e.g. chemical for GLP). The second change was the title “Guidance for Industry” to a “Guide“. Maybe the document type “Guidance for Industry” would remind you to US regulations and you are right. But in the EU such a document type in a regulatory structure and understanding is also not known. Maybe the roots of the first versions were coming from US or consultants or authors from this region. In general an own opinion might be better as to listen to any opinion-makers with commercial interests. Continue reading “MHRA’s GXP data integrity guide published – March 2018”