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QA/QC

 

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.…

Expert View: Standardisation through automation

29 February 2016 | By SOTAX Group

There are several sources of variability in the “inherently poor design” of compendial dissolution apparatus types. Nevertheless, dissolution testing is a QC requirement for many products, and so the industry faces the challenge of implementing and managing fleets of dissolution equipment. However, through instrument and process design and automation, managing…

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…