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Adapting to an Everchanging Regulatory Landscape

Compliance in regulated laboratories isn’t static; the rules and guidance are constantly evolving to improve standards and the quality of drug products. However, the areas of non-compliance found during regulatory inspections typically remain unchanged, with the same issues being observed from year to year. The bulk of the non-compliance issues arises from breaches of basic principles of Good Manufacturing Practice and Good Laboratory Practice (GxP), requirements relating to procedural control, documentation standards, and a lack of scientific investigation, training, maintenance, qualification and validation of both hardware and software. Garry Wright at Agilent Technologies analyses how the regulatory landscape has been changing.