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Microbiology

 

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Current activities of the USP general chapters

24 August 2016 | By

From a microbiological perspective, pharmaceutical products fall into two categories – nonsterile and sterile. For both categories manufacturers must eliminate, or minimise, potential health risks to patients related to microorganisms and the toxins they produce, whilst maintaining product quality. Many contributing factors may affect the quality of a medicine or…

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A novel approach in assessing the antimicrobial efficacy of eye drop products

4 May 2016 | By Mostafa Eissa, Hikma Pharmaceuticals

The microbial contamination of medicinal products constitutes a continuous threat to the health of consumers, which may negatively impact pharmaceutical companies’ reputability. However, multidose sterile pharmaceutical products are prone to contamination either from the normal flora of the human body or from the surrounding environment, following their misuse by patients.…

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The challenges of riskbased environmental monitoring in sterile product filling

29 February 2016 | By

Completing risk assessments is an inherent part of good manufacturing practice (GMP) and risk-based environmental control and monitoring (EM) in sterile product filling within isolators and restricted access barrier systems (RABS). This article considers the challenges the pharmaceutical industry faces in characterising conventional risk assessments like failure modes and effects…