USP's first TG - Control Strategies for Solid Oral Drug Product
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USP is excited to share our first technical guide (TG) on PCM, focusing on solid oral drug product manufacturing control strategies.
As we all know, the concept of control strategy is well...
https://cmkc.usp.org/forum/defaultsection/technical-guides/69
A PAT-based qualification of pharmaceutical excipients produced by batch or continuous processing
09 Jun 2023 | Contributor(s):: Hertrampf A., Müller H., Menezes J.C., Herdling T.
Pharmaceutical excipients have an influence on the main requirements for medicinal products (viz., quality, safety and efficacy) but also on their manufacturability. During product lifecycle it may become necessary to introduce minor changes (e.g., to continuously improve it) or major changes in...