Abstract

Many factors can affect analytical results, Handling sample preparation criticalities to ensure first time and all time correct results

Applying QbD approach during drug developmental phase in sample preparation will Improve the efficiencies and analytical results.

Working with regulated environment in QC laboratory is challenging and minimising OOS should be the task during the In-process tests, Batch release, achieving trends in stability data in various packs and conditions.

Little attention during sample preparation can dramatically reduce the warning letters in laboratories.