PIC/S Data Integrity Draft Guidance Issued Last Week

August 15, 2016 / by Paul Moran

logo.pngBroughton Software received notice that a PIC/S Data Integrity Draft Guidance was released last week. Direct copy has been provided below, including a link to the draft guidance:

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 In April 2016, the American FDA issued a first draft Guidance for Industry - "New FDA Draft Guidance Data Integrity and Compliance with cGMP" -  and in July 2016, the British MHRA issued a third draft - "MHRA GxP Data Integrity Definitions and Guidance for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" (see Sources below) and simultaneously the European Medicines Agency (EMA) extended their 'Questions and answers: Good Manufacturing Practices' webpage by 23 answers on Data Integrity questions (see Sources below).

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

data integrity - 2017 deadline

Topics: News, Data Integrity, pharmaceutical manufacturing, FDA, MHRA

Paul Moran

Written by Paul Moran

Dr. Paul Moran is the founder of Broughton Laboratories Ltd and Broughton Software Ltd who serves as their Chief Executive. As a chemistry graduate with a PhD in Biotechnology, Paul began his career at the US pharmaceutical manufacturer Johnson and Johnson. In his role as QC Laboratories Manager, Paul obtained Six Sigma Black Belt certification. Paul entered the world of contract QC testing in 2003 supporting the successful growth of a contract laboratory leading to its merger in 2005. Paul started his first venture in 2006, establishing Broughton Laboratories as one of the leading UK MHRA and US FDA GMP licensed contract laboratories with its own dedicated stability storage facility which opened in 2011. The spin-off company, Broughton Software, was established in 2012 to provide a LIMS solution for regulated QC Laboratories. LabHQ LIMS launched its 4th release in September 2015.