Designing for Quality

Jul 19, 2016

Over the past several years, there has been a steady rise in new biologic drugs coming onto the market for the treatment of chronic conditions such as multiple sclerosis, rheumatoid arthritis and autoimmune diseases. This trend is likely to continue in the future, with the IMS Institute for Healthcare Informatics predicting that the market for biologics will grow to $221 billion by 2017. Along with this new class of drugs comes a corresponding increase in selfadministration systems, which offer patients who must repeatedly self-dose the freedom to do so outside of the doctor’s office or clinic. The following article by ...

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Parenteral Manufacturing and Industry 4.0

Jul 19, 2016

Industry 4.0 will be a game changer in how the patient will interact with all the partners who are involved in all aspects of the wellbeing of the end-user. Real-time data on the status of the health situation of the individual will have the possibility of flowing seamlessly to an array of partners. Morten Munk and Gert Moelgaard at NNE Pharmaplan submit an overview of parenteral manufacturing. ...

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Comparison of Good Manufacturing Practice Compliance Requirements – European Union, United States and India

Jul 19, 2016

The intentions of the current study are to expedite the compliance requirements to support the regulatory approval for selected pharmaceuticals in the United States, the European Union and India. The literature search is done using different resources like regulatory authority websites, pharmaceutical review articles, journals and public domain. To ensure the quality, all pharmaceutical manufacturers are required to establish and implement effective quality management systems. B. Naga Vamsi, Balamuralidhara V., Shenaz Z Khaleeli and Srinath S from JSS College of Pharmacy compare the GMP compliance requirements in Europe, the US and India. ...

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