What is the most time-consuming aspect of a Qualified Person's role in Good Manufacturing Practice (GMP)?

This video is a short discussion, between the Managing Director of Inglasia Ltd (Anju Nadarajah) and The Qualified Person (Lynne Butcher) on the aspects of the QP's role in ensuring the manufacturing of medicinal product, is in accordance with the product's regulatory approved specifications and GMP, every time.

Anju Nadarajah & Lynne Butcher, on the QP's role in batch release

All aspects of manufacturing, of every batch, needs to be scrutinised and this can take a considerable amount of time, if documentation is all in paper format or managed through multiple electronic systems.

Part of that scrutiny is knowing how planned and unplanned deviations reach the batch record, and how quickly a deviation reaches the QP often depends on how it is classified as critical, major or minor.

Lynne Butcher discusses how simplifying processes, through integrated and automated electronic Quality Management Systems, can support in optimising the batch release process.

Learn how Inglasia Intuitor^™ supports the Qualified Person in their batch release role.