-
- Posts: 32
- Joined: Thu Aug 27, 2020 10:58 am
Pharmacopeial Method Qualification Options
Discussions about methods, troubleshooting and best practices across both pharmaceutical and biopharmaceutical analysis.
3 posts
Page 1 of 1
If a Drug Product didn't have a USP Monograph but one did exist in the EP, would the FDA accept an EP Method in a submission as long as it was appropriately qualified?
-
- Posts: 3510
- Joined: Mon Aug 30, 2004 11:43 pm
If I was still working, I'd sure push my boss and QA to accept that.
Many FDA regulations are too much of a gray area for my liking.
Many FDA regulations are too much of a gray area for my liking.
-
- Posts: 6
- Joined: Mon Jun 01, 2020 9:23 pm
- Location: Athens, Greece
Latest Usp editions have the trend to remove various things, I recently found out that they removed an API and also it's ref std. So I changed to BP or EP or at least if there is any relevant iso method
3 posts
Page 1 of 1
Who is online
In total there is 1 user online :: 0 registered, 0 hidden and 1 guest (based on users active over the past 5 minutes)
Most users ever online was 1117 on Mon Jan 31, 2022 2:50 pm
Users browsing this forum: No registered users and 1 guest
Most users ever online was 1117 on Mon Jan 31, 2022 2:50 pm
Users browsing this forum: No registered users and 1 guest
Latest Blog Posts from Separation Science
Separation Science offers free learning from the experts covering methods, applications, webinars, eSeminars, videos, tutorials for users of liquid chromatography, gas chromatography, mass spectrometry, sample preparation and related analytical techniques.
Subscribe to our eNewsletter with daily, weekly or monthly updates: Food & Beverage, Environmental, (Bio)Pharmaceutical, Bioclinical, Liquid Chromatography, Gas Chromatography and Mass Spectrometry.
- Follow us on Twitter: @Sep_Science
- Follow us on Linkedin: Separation Science