Year 2001 was the dawn of a new era for the pharmaceutical industry. Over the past decades, since the Thalidomide scandal, regulatory actions ensured that quality of drugs, active pharmaceutical ingredients and biological products released to market was no longer an issue. However, difficulties still remain with the development and continuous operation of consistent and reliable processes leading to high value products, fit for their intended use. End-product quality control, quarantine and time-dependent end-point characterisation govern quality assurance strategies of the sector.
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