The European Medicines Agency has released new GMP guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. EMA’s GMP/GDP Inspectors Working Group developed this set of questions and answers with advice for stakeholders on measures that ensure data integrity and minimize risks at all stages of the data lifecycle in pharmaceutical quality systems.
The advice applies to both paper-based and electronic systems. It specifically addresses:
- assessment of risks to data integrity in the collection, processing and storage of data;
- risk management measures at various stages of the ‘data lifecycle’;
- measures to ensure data integrity for activities contracted out to another company.
The document states that senior management is responsible for promoting a quality culture, along with implementing organizational and technical measures which ensure data integrity. The document goes on to state that “senior management should ensure that data integrity is assessed, mitigated, and communicated in accordance with the principles of quality risk management.” Additionally,
- the effort and resource assigned to data integrity measures should be commensurate with risk to product quality, and balanced with other quality assurance resource demands
- even though long term measures may be identified to achieve the desired state of control, interim measures should also be implemented to mitigate risk and should be monitored for effectiveness
- the importance of data integrity to quality assurance and public health protection should be included in personnel training programs.
23 questions related to data integrity have been added to the document. The new Q&A address topics such as assessing data risk and criticality, data lifecycle management, compliance of data integrity to ALCOA principles, preservation of electronic data, design and control of paper documentation systems, expectations for a data integrity self-inspection program, review of electronic data, and responsibilities and expectations for data integrity between a contract giver and contract acceptor.
Regulators rely on the data generated during testing, manufacturing, packaging, distribution and monitoring to evaluate the quality, safety and efficacy of medicines and to monitor their benefit-risk profile throughout their life span. Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities.
The document is aligned with existing GMP guidance published by some regulatory authorities participating in the PIC/S. It should be read in conjunction with national guidance, medicines legislation and the GMP standards published in Eudralex volume 4.