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Dec 12

Foreign particulate matter in pharmaceuticals

There has been a recent rise in the number of pharmaceutical product recalls due to the presence of Foreign Particulate Matter (FPM), and its effect on product efficacy and safety.

FPM is either inherent (from the product itself), intrinsic (from the production process), or extrinsic (contaminating particles from outside). There is a regulatory requirement for manufacturers to thoroughly investigate any incidents involving FPM and to determine its origin. In doing so the manufacturer needs to be able to demonstrate that they have a thorough understanding of their manufacturing process and control of the composition of their final product. Detection and analysis of FPM is a critical part of product development and quality control, and today forms a routine part of most upstream processing.

 

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LGC has a proven track record in FPM analysis having carried out numerous FPM investigations involving active pharmaceutical ingredients, excipients, final dosage forms, process and packaging materials. Our services cover particle counting and morphology categorisation, identification of unknowns, root-cause determination and the development of bespoke FPM methodologies and reference libraries.

This rapid turnaround service allows our customers to complete their investigations in a timely and efficient manner. All investigations need to be fit for purpose and our study managers are able to call upon a wide range of FPM characterisation techniques including light microscopy, infrared (FT-IR and NIR) microscopy, scanning electron microscopy (SEM-EDX), x-ray diffraction and mass spectrometry. In addition to commercially available libraries we have assembled extensive component, product and contamination reference libraries.

To find out more about our expertise, please view our webinar on demand and download our fact sheet.

 

View webinar >>> 

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Download fact sheet >>>

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