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Here, Dave Elder explores proposals for new FDA rules on…
Here, Dave Elder explores proposals for new FDA rules on tobacco product manufacturing. How could strategies for controlling tobacco-specific nitrosamines compare with those for nitrosamine drug substance-related impurities?
The introduction of ICH Q3D (Guideline for Elemental Impurities)1 was…
The introduction of ICH Q3D (Guideline for Elemental Impurities)1 was an additional safety-based guidance for toxic impurities that complemented the existing ICH Q3C(R5) (Impurities: Guideline for residual solvents)2 and ICH M7(R1) (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk);3 as well as the…
In this supplement: Real-time PCR detection of Staphylococcus aureus in…
In this supplement: Real-time PCR detection of Staphylococcus aureus in pharmaceutical products contaminated with mixed bacterial cultures, and an ICH Q3C(R5) elemental impurities update.
In this issue: Anastasia Petropoulu focuses on some of the…
In this issue: Anastasia Petropoulu focuses on some of the Pharmaceutical Quality Systems in relation to QA of manufactured medicines, and Dave Elder looks at method/process capability in terms of QA/QC.
This issue recaps the Joint Pharmaceutical Analysis Group's symposium on…
This issue recaps the Joint Pharmaceutical Analysis Group's symposium on Continuous Manufacturing, and explores the "perfect technology storm" facing the pharmaceutical sector.
This In-Depth Focus looks at the benefits of mass spectrometry…
This In-Depth Focus looks at the benefits of mass spectrometry for the characterisation of protein higher order structure and for stability testing.
Microbiological contamination of non-sterile medicinal products is an infrequent, but…
Microbiological contamination of non-sterile medicinal products is an infrequent, but longstanding and recurring issue. But there is no ‘one size fits all’ approach towards objectionable organisms, says David Elder...
Particle size reduction is a fast and cost-effective answer to…
Particle size reduction is a fast and cost-effective answer to increasing the exposure of poorly soluble oral drugs by increasing surface area and thereby improving dissolution rate. This approach will only work for DCS IIa1 drugs where dissolution rate is the rate-limiting factor for absorption. This may be applicable to…
When the United States Food and Drug Administration (FDA) called…
When the United States Food and Drug Administration (FDA) called for a shakeup of pharmaceutical production in 2002 it recommended the early adoption of technological advances and the application of modern quality management techniques. It believed that this would make manufacturing processes more robust and improve product quality.1
The EMA recently introduced labelling requirements for some common excipients…
The EMA recently introduced labelling requirements for some common excipients based on an in-depth assessment of their safety profiles, particularly in the paediatric population.1 This article considers their use in multidose products...
Film coating is a common step in tablet manufacture that…
Film coating is a common step in tablet manufacture that can be used to improve product appearance, organoleptic properties, or to facilitate swallowing. Functional film coats can also be used as a part of the product’s stabilisation strategy and to modify or delay drug release.
In this issue Dave Elder discusses issues around the manufacture…
In this issue Dave Elder discusses issues around the manufacture of film coatings and Adeyinka Aina and colleagues consider the potential medicinal uses and efficacy of the flavonoids epigallocatechin and epicatechin, which can be extracted from the Spondias mombin plant.
During 2002, the United States Food and Drug Administration (FDA)…
During 2002, the United States Food and Drug Administration (FDA) requested rationalisation and modernisation of the manufacturing base for pharmaceutical production. This was in the hope that modernising the supply chain would enhance the robustness of manufacturing processes, thereby reducing product failures and, importantly, significantly enhancing product quality.1 The FDA’s…
