Workshop examines new process analytical technology guidance for manufacturers
Pictured (left to right): David Radspinner (Aventis), John Clements,
Ken Leiper (Benson Associates), Chris Watts (FDA), Keith Pugh (MHRA),
Vibhakar Shah (FDA), Ingrid Maes (Seimens) and Ali Afnan (FDA) |
Representatives from UK and US regulatory agencies met pharmaceutical industry professionals earlier this week to discuss new US Food and Drug Administration guidance on process analytical technology (PAT).
The workshop was hosted by the Royal Pharmaceutical Society in London.
John Clements, the Society’s science secretary, explained that
the current practice of testing small samples of medicines at the end
of the manufacturing process is no longer regarded as a satisfactory
measure of quality. Regulators and manufacturers increasingly recognise
the benefits of monitoring the quality of materials throughout the manufacturing
process. Using process analytical technology, any problems can be picked
up as they arise and the information can be fed back into the manufacturing
process.
The workshop was held in collaboration with the FDA and provided an opportunity
for delegates to learn about the implications for the industry of the
new PAT guidance, and to discuss these with speakers from the FDA and
the Medicines and Healthcare products Regulatory Agency. |
The
Pharmaceutical Journal
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