PharmOut is proud to offer you a new data integrity training course initially only to be offered in Melbourne and Sydney.
Data integrity has been a significant concern for regulators for some time, we only need to look back at the world’s biggest medicines recall, see the TGA website for this Media Release from 24 August 2003, “The Australian public should not forget how bad the manufacturing practices were at XXX Pharmaceuticals which prompted what may be the world’s biggest medicines recall.” Court evidence given at the time by the head of IT for the company, said that he was asked “Can you make it so the data is not retrievable by anyone?”
So an old problem that is not going away, only last month the TGA inspectors received in house training by one of the worlds leading Data Integrity experts, this has led to further inspection citations with at least four companies seeking our help over the last few weeks, so a hot tip for your next inspection.
You can read more about Data Integrity in a presentation I gave at a PDA dinner last year on Success by Design.
Most people are now aware of the great MHRA guidance and their series of blogs, and then last week, the FDA released a draft guidance on Data Integrity and Compliance with cGMP. The 14th of April 2016 has seen the U.S. Food and Drug Administration (FDA) release a draft version of Data Integrity and Compliance With Current Good Manufacturing Practice – Guidance for Industry.
FDA Data Integrity Guidance
This timely release shows how the FDA sees the current state of data integrity and the application of its fundamental principles throughout the industry. The Background section states that, “In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections”. We only have to look at the top 10 warning letter findings for finished pharmaceuticals in 2015 to see that data integrity and access control are heavily featured and why this guidance document has been released.
The document itself is structured as a questions and answers style of guidance with the first question focusing on defining the core terms of data integrity including:
- The term data integrity itself and its relationship to ALCOA,
- Metadata and how a data value on its own is meaningless without its additional metadata (e.g. unit, time, date),
- Audit trail and what it should include to demonstrate the “who, what, when and why” for a record,
- How the FDA uses the terms static data, dynamic data, backup and systems.
The rest of the draft guidance is made up of 17 questions that focus on the following topics:
- Validation and what should be included,
- Access control including roles, restrictions and the use of common logins,
- Document control including the use and management of blank forms,
- Audit trails and their review,
- Electronic records, paper records, originals, copies and printouts including the differences between them, when they are classed as GMP records, and how/when these can be used as evidence or for retention,
- Electronic signatures and their management, application and use on master production records,
- Reprocessing and ‘system suitability’ testing involving the use of actual samples for test/prep/equilibration runs as a means of disguising ‘testing into compliance’,
- Quality management system, falsification and training issues around data integrity,
- FDA inspections and observations.
We definitely recommend reviewing this new draft FDA guidance and performing a quick gap analysis on your company’s systems.
Data Integrity Training
Since last year’s GMP and Validation Forum where PharmOut hosted one of the world’s leading experts in this area, Sion Wyn, we have been working hard on developing a practical in the trenches experiences Data Integrity Training Course to be held in Melbourne and Sydney.
Data integrity, Quality Metrics, Continuous Product Quality Review and other industry hot topics will be discussed in detail at this year’s GMP and Validation Forum.
To read more on Data Integrity, click here.