Every so often we like to eavesdrop on some of the better QbD- and Quality-related conversations happening on LinkedIn pharma groups. Here are November’s hot discussion threads. (The group name is in parentheses. Not a member? Ask the group manager for an invite!)
Who are the leading PAT and QbD service providers working in the pharma space? (Process Analytical Technologies)
Perhaps the better question, group members argue, is how many “QbD service providers” are truly fit-for-purpose?
What are good resources on QbD for Generic APIs? (Quality-by-Design)
Some good ideas shared, and group members disagree as to whether there are differences between QbD for generics and that for other industry segments.
Can anybody share experience of validating multiple use of sterilizing grade filters for regulated market and acceptance of the same by regulators? (ISPE)
Some heated discussion regarding whether this practice is common and should be done in the first place.
How do you control objectionable organisms in Purified Water? (PDA)
This thread (or should we say “stream”?) has some good input and could use more.
What needs to happen to keep QbD moving in 2012? (Pharmaceutical Manufacturing and PharmaQbD)
Here’s a recent post on our group. We’d love to have your opinion!
How relevant is cGMP for extracting a natural API? (Generic Pharma)
A bit of spam to sort through, but some useful resources and discussion.
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