Plans to lift hospital manufacturing standards
Draft good practice
guidelines on small-scale manufacturing by hospital pharmacies will demand higher standards than currently apply in many UK hospitals.
The guidance, produced by the international Pharmaceutical Inspection
Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S),
aims to convert standards of industrial good manufacturing practice into
something more relevant to smaller units.
A response to the proposals prepared by the Royal Pharmaceutical Society
and compiled from comments made by UK hospital pharmacists suggests that
compliance with the proposed standards would increase both workload and
cost.
Among proposals that would drive up workload are plans to require higher
standards of documentation, including assessments of the therapeutic
need for any products, along with information on their safety, toxicity,
biopharmaceutical characteristics, stability and design before they can
be made. Anything that is to be made repeatedly would also need baseline
quality control data and stability information.
Costs would be pushed up by higher standards of protective clothing,
more frequent cleaning or replacement of reuseable items, such as cleaning
mops, and more frequent environmental testing.
When consultation on the draft started in October 2006, Tobias Gosdschan,
head of the PIC/S expert circle on hospital pharmacy, said: “The
key element of the new guide is the demand for a comprehensibly designed
and correctly implemented quality assurance system incorporating the
principles of good manufacturing practice.”
He said that the proposed requirements were based on risk and adopted
a graduated approach based on product types and quantities.
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