The integrity of the data behind the production of pharmaceutical products is paramount. In recent years, the U.S. Food & Drug Administration (FDA) has increasingly observed data integrity related Current Good Manufacturing Practices (CGMP) violations during CGMP inspections.At the recent Emerson Exchange conference, Emerson’s Michalle Adkins co-moderated the Life Sciences Industry Forum session with experts from pharmaceutical manufacturers to delve into data integrity compliance. The other big topic discussed in the forum session, continuous manufacturing, will be highlighted in a subsequent post.
QAVC Consulting‘s Chris Wubbolt presented on the subject of data integrity, and provided an overview on current guidance, shared regulatory considerations regarding data integrity, and described implementation of data integrity controls.
Data integrity is defined as the completeness, consistency and accuracy of data. It should be attributable, legible, contemporaneous, original (or true copy), accurate, enduring, complete, consistent and retrievable. Examples of true copies include photocopies, microfilm, microfiche, or other accurate reproductions of the original records.
- MHRA [Medicines & Healthcare products Regulatory Agency] – GMP Data Integrity Definitions and Guidance for Industry
- WHO [World Health Organization] – Guidance on Good Data and Record Management Practices
- FDA – Data Integrity Guidance and Compliance with CGMP
- MHRA – GxP Data Integrity Definitions and Guidance for Industry
- PIC/S [Pharmaceutical Inspection Co-operation Scheme] – Good Practices for Data Management and Integrity
- EMA [European Medicines Agency] – Data Integrity Guidance Q&A
Data integrity is not a new concept and many principles from the paper & ink era still hold true today. Examples include:
- Backup data are exact and complete, and secure from alteration, inadvertent erasures, or loss
- Data be stored to prevent deterioration or loss
- Certain activities be documented at the time of performance and that laboratory controls be scientifically sound
- True copies or other accurate reproductions of the original records
With the expectation of data reliability and accuracy by the regulatory bodies, CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Pharmaceutical and biotech manufacturers should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and business models.
Chris highlighted the MHRA guidance in detail and explained key points around data governance, data life cycle, and controls in line with the criticality of the data and the importance to quality, safety and efficacy decisions. Integrity risks are dependent on the ability to configure or manipulate the data, the vulnerability to unauthorized changes or deletions and the opportunity to detect these alterations upon review.
Automation systems and manufacturing execution systems such as the DeltaV distributed control system and the Syncade manufacturing execution system software support these data integrity requirements through user management for roles and authority levels, electronic signatures, smart device diagnostics, logged and validated workflows and transactions, audit trail, backup & recovery, and capture of an electronic batch record during the processing of a batch.
Michalle and Life Sciences consulting team can help in the planning and execution of effective data integrity measures to comply with the global regulatory agencies and streamline the production and data gathering & retention process.
You can also connect and interact with other pharmaceutical and biotech automation experts in the Life Sciences group in the Emerson Exchange 365 community.