Industry News: LGC’s impurity and contamination centre of excellence

The presence of contaminants or impurities in pharmaceutical and consumer healthcare products may lead to undesirable pharmacological and/or toxicological effects.  Contamination and impurity identification and profiling is, therefore, critical to the safety, efficacy and quality of a pharmaceutical or consumer healthcare product, and is a regulatory requirement.

Foreign particulate matter (FPM)  

The presence of particulate contamination in pharmaceutical and biopharmaceutical products can lead to loss of batches, plant shutdowns, product recalls or regulatory action. FPM contamination still remains as one of the leading causes for product recalls¹.  

Manufacturers of pharmaceutical and biopharmaceutical products are required to demonstrate a  thorough understanding of their processes which includes carrying out appropriate investigations to determine the identity and origin of any contamination that may occur.  For FPM investigations, LGC’s Impurity and Contamination Centre of Excellence offers:  

• Particle counting – to ensure that unintended and non‐therapeutic particulates in products  do not exceed established limits  
• Particle characterisation – to determine the identity and source of origin; essential for root  cause analysis investigations

LGC has a team of experts specializing in forensic analysis of particulate contamination using a variety of analytical techniques and who routinely examine, extract and analyze particles of different sizes and shapes, found in a wide variety of matrices. Every case is different, but LGC can tailor analyses to suit your unique requirements, and even build a searchable reference library consisting of typical materials your product might come into contact with for quick comparison and identification in the future.  

Find more information on LGC's Foreign particular matter testing services >>

Reference

1. https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm