Over
the past few months we have seen a significant increase in the number
of enquiries coming from NHS Pharmacy Departments, in particular
Pharmacies that adhere to GMP and are regulated by MHRA.
The
driver behind this rise in interest seems to be as a result of a Note
of Guidance on Pharmaceutical Quality Systems issued by the European
Medicine Agency earlier in 2007, entitled ICH Topic Q10 -
Pharmaceutical Quality Systems. In short, Topic Q10 describes an approach to an effective quality management system based on ISO concepts, GMP and ICH Q9.
Since
its inception Q-Pulse has been developed based on ISO concepts and with
over 250 existing Q-Pulse installations across the NHS, increasing
numbers of NHS Pharmacies are making the decision to deploy Q-Pulse to help them to effectively manage Quality in-line with GMP and ICH Topic Q10 guidance.
If
you work in an NHS Pharmacy we would be interested to hear what impact
the ICH Topic Q10 guidance has had on the way you manage Quality. Or,
if you have recently been audited by the MHRA and you've noticed a
shift in focus, say from document control to Corrective and Prevent
Action management, we would value your comments.
Discuss this further in the linked
forum.