This process encompasses the collection, processing, tracking, analysis, and dispatch of laboratory reports to clients. Laboratory results influence decisions regarding the safety, quality, and efficacy of regulated products, significantly impacting public health. Samples are received in the designated unit following internal procedures, accompanied by a completed test request form.

The assigned officer verifies that all required documentation is present. If no discrepancies are found, samples are processed electronically via the Laboratory Information Management System (LIMS), in accordance with the relevant SOP or Work Instruction.

A Laboratory Information Management System (LIMS) is software that facilitates effective sample and data management, automates workflows, and integrates laboratory instruments.

Samples are allocated to testing units with the capability and resources to perform analysis, based on the availability of pharmacopeial or validated dossier methods.

Samples are analyzed according to risk categorization and current approved monographs, following established SOPs.

In the event of an out-of-specification result, the relevant SOP must be followed; the worksheet should be reviewed by a supervisor, and the results entered into LIMS, printed, and dispatched accordingly.