Featured Articles
TABLETTING EQUIPMENT AND TECHNOLOGY
Editorial team, Pharmaceutical Technology Europe
In this month’s special feature we will take a look at some of the latest innovations in tabletting equipment and technology.
*This feature will also be distributed in digital format in June and will contain exclusive editorial material and a product showcase.
Contributing companies: TBC
GREEN MANUFACTURING
Working towards greener manufacturing
Fedra Pavlou (Pharmaceutical Technology Europe)
PTE spoke with Dr Peter Dunn, Global Green Chemistry Lead at Pfizer, about the pharmaceutical industry’s commitment to green manufacturing, some of the key changes that yield significant energy efficiencies and the strategy behind the company’s green chemistry programme. Dr Dunn says how he believes Pfizer compares with its peers in its commitment to green manufacturing and he discusses how the industry can further improve its processes in the future.
REGULATORY
Environmental risk assessment of pharmaceuticals
Dr. Daphne de Roode (NOTOX BV).
In response to increasing concern on the fate and effects of pharmaceuticals in the environment, an environmental risk assessment has been introduced as a requirement for all new marketing authorisation applications of pharmaceuticals. An assessment of potential risks to the environment of medicinal products is a step-wise, phased procedure that may be terminated when sufficient information/data is available to either indicate that the medicinal product is unlikely to pose a risk to the environment, or to identify and sufficiently characterise the potential risks. This paper presents the steps to be taken during the phased procedure.
Deviating from GMP
Oliver Schmidt (Concept Heidelberg)
The author discusses common deviations from GMP identified during routine audit inspections and provides advice on how to comply with cGMP standards and avoid warnings from the regulators.
QPSHARE: a new way to share audits
Qualified Persons Association
The Qualified Person's function and responsibility within the European Pharmaceutical legislation is unique and approach requires the QP to certify each batch of finished product within the EC/EEA before being released for sale or supply and to have an oversight about the respective quality systems. To support the QPs using the enormous potential of shared audits, the QP Association has developed the "QPSHARE" database that will allow QPs to increase the efficiency in auditing and qualifying their company’s suppliers.
DATA MANAGEMENT
Purpose-built informatics solutions take enterprise level productivity to a new level for pharmaceutical companies and their strategic partners
Gary Walz (Thermo Fisher Scientific)
Enterprise-level integration is crucial in today’s business climate, where near instantaneous response is required by pharmaceutical companies and their outsourcing partners to protect the public and the environment. Purpose-built LIMS enables pharmaceutical companies to more fully integrate the work of the manufacturing laboratory across the organisation and to enable collaboration and better communication with their outsourcing partners.
ASK THE EXPERT
Powder characterization today
Tim Freeman (Freeman Technologies)
The author discusses innovations in powder characterisation for pharmaceutical processes.
Columns
OUTSOURCING
Topic to be confirmed.
Jim Miller
SPOTLIGHT ON…
Change is in the air for the European Clinical Trials Directive.
Faiz Kermani
Product Profile |
Agilent |
The Agilent 2100 Bioanalyzer plus the Agilent High Sensitivity Protein 250 Kit automatically detects and quantifies protein impurities down to 0.05% for superior Protein QC in a production-ready method!
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Product Profile |
Agilent |
Poroshell 120 HPLC columns give you speed and resolution like a sub-2 µm column with up to 50% less back pressure – usually less than 400 bar. And they have standard frits, so they are more forgiving for dirty samples. 
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Product Profile |
Shimadzu |
Shimadzu has introduced the Nexera ultra high-performance liquid chromatography (UHPLC) system. The LC-30A Nexera is unsurpassed in high-speed and high-resolution analysis and productivity. It meets the needs of the most demanding markets such as pharmaceutical and the food industry.
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If you would like to submit an article to Pharm Tech Europe, contact Fedra Pavlou, Editor in Chief - fpavlou@advanstar.com
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