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Raising non-conformities

Raising non-conformities

Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit.  This is somewhat of an old-fashioned way of auditing and whilst it may be the way audits have...
Dealing with problems – for good

Dealing with problems – for good

Problems happen in work and in life.  Problems also happen within any quality system. GMP requires problems to be dealt with correctly: “any deviation  … should be avoided as far as possible.  If a deviation occurs, it should be approved in writing … (EU GMP...
RPi Training

RPi Training

RPi Training Following a recent announcement by the MHRA this article highlights the importance of the RPi role after the transition period has finished and the RPi training available from Inspired Pharma RPi Training Following a recent announcement by the MHRA this...
The 2018 MHRA GDP Symposium

The 2018 MHRA GDP Symposium

The MHRA have just released a quite lengthy article about the 2018 Good Distribution Practice (GDP) Symposium held in late November in London and Glasgow. For those of you who did not attend the MHRA GDP event or missed the article the key highlights included: an...