Figure 1. Figure 1 shows the critical elements of a QbD loop. The QbD concept is supported by US-FDA. (Source:Ima)
Risk Management

Quality by Design Approach for Lyophilization Process Scale-up

The Quality by Design (QbD) term was originally introduced in the pharmaceutical lexicon in 2005 via ICH Q8(R2) and additionally described in ICH Q9 and Q10. [1] In essence, QbD is a systematic risk management approach which emphasizes maximum product-, process-understanding, and process control in contrast to a trial and error-based quality control approach that banks on success primarily via end stage product testing. [2]

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More and more automotive companies are turning to hydrogen as an alternative to electric motors.  (Source:©Elnur - stock.adobe.com)
Industry Insight

What is Hydrogen and How Can it Help Us?

The increasingly relevant climate change coupled with the worldwide static increase in energy consumption by industry and private households requires us to rethink. New climate-neutral alternatives are being promoted more and more. One of the biggest hopes in the field of climate neutrality is hydrogen. But what is hydrogen? How can we produce it and where can it help us?

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Galleries

Six different production sites located in Italy, the USA and China, each one specialized in a specific step of the process, ensure a technologically advanced product portfolio. (Source: Ima)
Pharma Equipment

Vaccine Manufacturing Lines from a Single Source

The Covid-19 pandemic is far from over, and the threat of future pandemics created by novel viruses is very real. There is a growing need to supply a global market with innovative medicines at a profitable cost. So pharmaceutical equipment manufacturers have to react quickly, while maintaining due levels of diligence and social responsibility. To meet this demand, we at Ima Group operate in highly specialized pharmaceutical divisions, focusing on specific processing and packaging areas, in order to provide our customers real added value based on two main criteria.

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PROCESS regularly reports on the Chinese chemical and pharmaceutical market with the format "China Market Insider". (Bild: ©sezerozger - stock.adobe.com)
China Market Insider

Beijing Views Engineering Plastics as Achilles Heel in Trade War

China wants to reduce its ‘import dependence’ on engineering plastics. This is stated in the new 14th five-year plan of the communist leadership in Beijing, which has its eye on the strategic value of these special chemicals used across a number of domestic industries. Recently, concrete targets for ‘self-sufficiency’ in these materials were published, reports the chemical newspaper Zhongguo Huagong Xinxi Zhoukan.

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