The Importance of Data Integrity in Pharmaceutical Quality Management System
The MHRA (2015) states “Data integrity (DI) is fundamental in a pharmaceutical quality management system which ensures that medicines are of the required quality and the data governance system should be integral to the pharmaceutical quality system described in EU GMP chapter 1.”
Furthermore the MHRA (2013) cites that “Based on review of the observed deficiencies, upcoming changes to GMP legislation and information received from other authorities; DI has been targeted as priority areas; DI issues, both as a result of bad practice and to a significantly lesser extent intentional fraud, have been observed across all geographical locations and sectors of the industry with some very high profile cases being observed recently. This will be one of the focus areas during inspections.”
In addition; the MHRA has communicated an expectation that companies will carry out a routine effectiveness review of their governance systems to ensure data integrity and traceability are maintained
If we in the pharmaceutical sector agree with this, then it no doubt necessitates that all our personnel must be made aware of this requirement. understand and comply.
What activities can your company perform to mitigate this being an issue during a regulatory inspection.
- Your company must start acting proactively to address this issue
- Have a documented procedure on Data Governance
- Perform a gap analysis including a quality risk assessment on your existing system to comprehend and remedy the identified gaps.
- Ensure that data integrity verification activities are embedded in your company’s internal audit processes.
- Create the relevant standard operating procedures.
- Delivery of the appropriate training to personnel.
- Where required get external input /advice to get the necessary assistance.
- Actively looks for opportunities to improve quality within the organisation.
- Ensure that staff are not afraid to report any failings in the system.
- Adopt behavioural procedures and technical steps to improve existing quality systems.
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