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GMP News

GMP Requirements for Ready to Sterilize (RTS) and Ready to Use (RTU) Containers

There is currently a growing interest in the supply of GMP pre-sterilized packaging material (e.g. ready-to-sterilize (RTS), ready-to use (RTU) products). However, suppliers are facing new GMP requirements (e.g. regarding validation of the sterilization procedure) which apply with the revised EU GMP Annex 1. How to demonstrate GMP-compliance?

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SwissGMDP Database now available

Swissmedic has made the new SwissGMDP database publicly available. The database lists all establishment licence holders domiciled in Switzerland, as well as all the operating sites and activities that are authorised. It is also possible to consult the GMP and GDP certificates.

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Management circumvents Quality Department in Deviation Classification - FDA Warning Letter

In a Warning Letter to a manufacturer of non-sterile drugs in the USA, the FDA summarises a whole series of deficiencies. Serious deficiencies were found both in microbiological control and deviation handling as well as in analytics.

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