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QP for GMP ASAP?

Recent reports in the media (http://www.in-pharmatechnologist.com/Regulatory-Safety/A-QP-for-GMP-That-is-the-suggestion-IRCA-launches-pharma-auditor-training) are suggesting that GMP auditors should have an equivalent professional qualification similar to that of a QP.  At Symbiosis, we asked our QA department what they think about this idea.  Murray McKay, QA director at Symbiosis with over 25 yrs experience said “This idea is not a new one.  I can see that a certain level of standardisation is a good idea.  We see a wide variation between auditors and it is a big issue in this industry.” McKay goes on to add that “while a qualification is a good idea – there is no substitute for experience”.  Lastly, in GMP licensed facilities is there even a need for auditing at all?  What do you think?  As always, we would be interested in hearing your opinion.  Please share your thoughts with us by sending an email to contact@symbiosis-pharma.com

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