The Application of Quality Risk Management to the Bacterial Endotoxins Test: Use of Hazard Analysis and Critical Control Points

Abstract

In the quality control process, risk analysis is a useful tool for enhancing the uniformity of technical choices and their documented rationale. Accordingly, it allows for more effective and economical laboratory management, is capable of increasing the reliability of analytical results, and enables auditors and authorities to better understand choices that have been made. The aim of this article is to show how hazard analysis and critical control points can be used to manage bacterial endotoxins testing and other analytical processes in a formal, clear, and detailed manner.

Hazard Analysis and Critical Control Points as a Quality Risk Management Tool in the Pharmaceutical Industry: A Systematic Review

“…Carducci Annalaura et al 65 the Author illustrates how HACCP may be utilized to formally, and clearly control bacterial endotoxins testing as well as other analytical procedures, leading to improved and even more consistent analytical results, considering the various errors that may impact BET (Methodology, equipment, reagents, etc.). It also illustrated how Haccp helps standardize every process phase Tim Sandle 66 discusses a case study on how a viral risk from a pharmaceutical process might be eliminated via HACCP.…”

Use of Hazard Analysis Critical Control Point (HACCP) methodology for biocontamination control: Assessing microbial risks and to determining environmental monitoring locations

“…Annalaura et al(20) "The application of quality risk management to the bacterial endotoxins test: use of hazard analysis and critical control points." The authors show how HACCP can be used to manage an analytical process (the LAL test) and propose how to conduct the necessary steps to assess test problems.…”