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4 October 2017 | By Jean-Marie Aulnette
Traceability and serialisation have been the talk of the industry for many years, with regulatory bodies worldwide starting to introduce legislation that will help to eradicate counterfeit medicines from the supply chain.
3 October 2017 | By Dr Zara Kassam (European Pharmaceutical Review)
As part of EPR's Women in Pharma series, Petra Wicklandt, Senior Vice President, Head of Global Chemical and Pharmaceutical Development, Merck, talks to Science Editor Dr Zara Kassam about facing challenges in the pharmaceutical industry and turning them into solutions...
3 October 2017 | By Dante J Marciani
Dante J Marciani, President and CSO of Qantu Therapeutics, reviews the current evidence and controversy in the hunt for a vaccine against Alzheimer's disease and considers the future.
31 August 2017 | By Dr Michael J. Miller
European Pharmacopoeia Chapter 5.1.6, Alternative Methods for Control of Microbiological Quality, was recently revised and published in Ph. Eur. Supplement 9.2. The new chapter comprises a number of significant changes from the original version published in 2006. Prior revisions to a similar chapter and technical report from the USP and…
The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients and active pharmaceutical ingredient (API), as well as the final drug product (see Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically…
22 August 2017 | By Dr Dennis Jenke
Plastic materials, widely used in pharmaceutical packaging systems, can interact with the packaged product by transferring leachables. Leaching is important, as foreign leachable impurities can adversely affect the quality, efficacy and safe use of the packaged product, due to their chemical or physical nature, reactivity, and/or toxicity.
22 August 2017 | By European Pharmaceutical Review
In this in-depth focus: Non-contact single cell adhesion and micromechanical property characterisation with ultrasound. Is high resolution mass spectrometry the missing piece in continuous bioproduction? Regulatory, clinical and logistics challenges of ATMPs in clinical research...
Quality control of freeze-dried oral formulations; challenges when developing novel approaches for the delivery of poorly-soluble drugs
A common obstacle encountered in the early stages of drug development is the formulation of poorly water-soluble drugs (PWSDs). One effective approach to improve the dissolution of PWSDs is to render such drugs into their amorphous or disordered form. However, amorphous materials are both physically and chemically unstable, and tend…
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…
21 August 2017 | By Piotr Zaborniak
The regulatory environment has a great impact on business, especially in healthcare. Non-compliance exposes companies to the risk of launch delay, delisting products from the market and out-of-stocks. Moreover, it can cause reputational damage affecting staff, consumer and shareholder confidence, reduce market opportunities, and affect the bottom line.