v9991,
It sounds like pharma management has QA exactly where they want them.
A shield from any responsibility for getting their work right the first time.
And independence compromised when it comes to audit.
John
It sounds like pharma management has QA exactly where they want them.
A shield from any responsibility for getting their work right the first time.
And independence compromised when it comes to audit.
John
there are countries where batch release is done by Qualified-Personnel, or approved chemists (QA)!
and obviously, QA would represent the external/regulatory audits and complaints/investigations.
incidently, its not any-often that QA is seem to be driving the improvements!!! beyond the scope of regulations-compliance
i am not saying that is the reason for it, but its a way to ensure that ALL KEY steps are adhered. (remember...regulation says that if we are not ensuring identified key steps, even if the product is good is it is adulterated...misbranded...not of quality etc)
I cant comment whether its pharma management or regulators, ....i am little lost...whether its need of standard! comprehensive as that of ISOs, six sigmas, (i think ICH Q10s are the answer for same) and offlate, regulators have been pushing for improvements/investigations,trends, CAPAs (interestingly, yet also in opposite documentation from documentation--> integrity)
Clearly we need to move onwards from procedures, checklists towards better tools, of effectiveness and efficiencies... ( PDCAs, COQ, Sigma levels, etc.,)
but surely we will be there and moving in right direction....
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