A recent Products Regulatory guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) specifies that data integrity is fundamental in pharmaceutical quality systems to ensure that medicines are of a stipulated quality. The concept of data integrity, or rather issues around it, has seen a noticeable upsurge due to increased harmonisation and co-operation among prominent regulators such as the MHRA, the US Food and Drug Administration (FDA) and others. The ramping up of various guidelines, clarifications, seminars and sessions on data integrity by the regulators and industry experts alike can only be taken as a cue that augmented data integrity compliance is the need of the hour.
Regulatory inspections are a key concern for global pharmaceutical companies because failing to meet requirements could bring untold damage to a business – resulting in diminished customer confidence, low trust by regulators, monetary loss to shareholders and even an adverse impact on any pending and future drug approvals.
Here, prevention is better than cure. Initiating remedial activity post inspection not only sends out the wrong message – that compliance only becomes important with hindsight – but the investment in remediation will also be in direct proportion to the magnitude and expanse of data integrity issues that have already emerged.
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