SMART quality & compliance
Eight Critical Success Factors to be considered in Times of Organizational Change and Transformation in Regulated Environment (Practical View)
“The Only Thing That Is Constant Is Change” (Heraclitus) In today’s globalized and fast changing world, it is very common that life science companies around the globe not only buy and sell entire subsidiaries, but also single parts of their operations and business units. In the highly regulated life science environment, such transactions should be compliant with local and global GxP regulations and in line with IT governance industry standards. For the information technology departments in the regulated life science space, this becomes more and more complex and of growing significance. One of the reasons for this is that IT…
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SMART quality & compliance
Good Distribution Practice: Brief Overview
“In theory there is no difference between theory and practice. In practice there is.” – Yogi Berra Good distribution practice, also known as GDP, was originated by the World Health Organisation (WHO) and the European Economic Community. It was written as a set of guidelines for the pharmaceutical suppliers. Today these guidelines are issued by various regulatory bodies. Who is responsible for GDP and why is it important? The marketing authorisation holder is responsible for GDP which is useful for prevent and guarding against risks that can cause dire consequences through standards of practice. The WHO describes GDP as…
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