October 14th 2025
The European Union aims to become the most attractive place for life science by 2030.
Quality by Design for analytical methods for use with orally inhaled and nasal drug products
The design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.
Effective complaint handling, investigations and adverse event reporting
September 1st 2008The challenges of ineffective quality monitoring of complaints, investigations and adverse event reporting can lead to patient harm or death, product withdrawal, and negative financial and brand impact to the organization.
Pseudo-polymorphic conversion by near-infrared spectroscopy
September 1st 2008Near-infrared spectroscopy (NIR) is suitable for the analysis of pharmaceutical samples in various solid forms, and can be used for determining chemical properties (e.g., content of drug, water), as well as physical properties (e.g., particle size, tablet hardness).
Epedigree in the Pharmaceutical Supply Chain
September 1st 2008EPedigree, track-and-trace technologies, and other tools for optimizing supply-chain management are of increasing importance to the pharmaceutical industry. The author examines the current regulatory and legislative framework for ePedigree for finished drug products as well as proposals to require electronic statements for pharmaceutical ingredients.