Comparative Analysis of Retention Sample Handling for Sorbitol and Sucrose Excipients at PT X

Abstract

The handling of raw material retention samples is a critical component of pharmaceutical quality assurance because it supports traceability, safety, and material quality throughout manufacturing. Studies specifically comparing retention-sample handling for sorbitol and sucrose excipients in industrial practice remain limited. This study aimed to compare the handling of sorbitol and sucrose retention samples at PT X and evaluate conformity with applicable procedures and Good Manufacturing Practice requirements. A qualitative approach was used through one month of direct observation, in-depth interviews with a sampling officer, a Quality Control analyst, and the Quality Control Raw Material Inspection Supervisor, and review of company procedures. The findings showed that sampling, labeling, storage, documentation, testing, retention-period control, and destruction were implemented in accordance with established procedures. Sucrose and sorbitol differed in sampling tools, retained quantities, physical form, sampling duration, and supplier packaging. Material traffic in the sampling room was identified as an operational constraint, particularly during sucrose sampling. The study demonstrates that excipient-specific handling requirements can be implemented within one integrated retention-sample system while maintaining traceability and quality-control effectiveness.