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Issue 5 2015


RMM: In-Depth Focus 2015

22 October 2015 | By

In this RMM In-Depth Focus: Implementation of a rapid methods portfolio at a pharmaceutical manufacturing site; Use of RMMs in quality control: challenges and benefits; Rapid assay for bioburden and other contaminations; RMM Roundtable...

Foreword: Importation testing: an unnecessary burden on industry?

22 October 2015 | By ,

One of the principle objectives of the Internal Conference on Harmonisation (ICH) initiatives was to introduce harmonised approaches, prevent duplication and eliminate wasteful and unnecessary testing. Although good progress was made initially, there was evidence that certain countries, regions and trans-national organisations were unhappy with some of the proposed harmonised…

New third-party audit scheme for excipient suppliers

22 October 2015 | By Iain Moore, President, EXCiPACT asbl

There has always been a regulatory requirement for pharmaceutical manufacturers to audit their starting material suppliers, but the expectations are even clearer now that these audits, including those for excipients, have to be in vivo. With increasing requirements for physical audits, can all pharmaceutical companies address the number of audits…

Continuous flow processing in the pharma industry – an unstoppable trend?

22 October 2015 | By Bernhard Gutmann and Christian Oliver Kappe, University of Graz

Continuous flow processes have many distinct advantages over discontinuous batch production and therefore, in the last century, continuous operation has become by far the most dominant form of production for high-volume and low-cost materials such as petrochemical and commodity chemicals. The first applications of continuous processes in the pharmaceutical industry…

Improving solubility with promiscuous multi-component drug crystals

22 October 2015 | By Masataka Ito, Kiyohiko Sugano and Katsuhide Terada Faculty of Pharmaceutical Sciences, Toho University

The physicochemical properties of active pharmaceutical ingredients (APIs) are critical to the success of drug development. Most of the APIs in oral solid dosage forms are contained as drug crystals.

Dynamic vapour sorption of freeze-dried pharmaceuticals

22 October 2015 | By Claudia Kunz and Henning Gieseler, Department of Pharmaceutics, University of Erlangen

Freeze drying is gaining in importance as the number of biopharmaceuticals that are unstable in a solution increases. According to recent reports, a growth of 10% may be expected for freeze-dried products in the next 10 years. The technique offers the opportunity to gently dry temperature-sensitive drugs such as proteins…

Counterfeit medicines and the need for a global approach

16 October 2015 | By David Shore, Pfizer

Counterfeit medicines pose a serious risk to public health around the world. The trade in fake drugs is considerable; according to Pfizer’s own company records, more than 200 million counterfeit doses of Pfizer product have been intercepted since 2004. Meanwhile, the issue of counterfeits has no single or simple solution…

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