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PDA Survey Shows Compliance Can Trump Science In Aseptic Processing

 
• By Joanne S. Eglovitch

PDA leaders weigh in on results of recent aseptic practices survey, saying pharmaceutical manufacturers may be carrying out certain aseptic practices to meet the expectations of regulators rather than the dictates of science. The survey also shows that despite adoption of technologies like RABS and isolators to keep workers away from sterile drug products, half the time they're still the root cause of contamination.

bended scientist works with manufacture machine

Pharmaceutical manufacturers’ aseptic processing practices are driven in part by regulatory compliance considerations that are not necessarily grounded in science- and risk-based thinking, a recent Parenteral Drug Association survey shows.

Two areas where the survey shows widespread compliance that trumps science: sampling of cleanroom air for large particles that are...

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Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
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More from Geography

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

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