• Off Topic

  Preparing stability data for FDA inspections

  Posted by Zink on March 10, 2020 at 9:14 pm

  If your manufacturer gets inspected and they ask you for your stability data of an OTC, how should they best be presented? 

  Are there any standard templates or formats? For e.g. RT and/or accelerated stability looking at % of the active over time?

  Microformulation replied 4 years, 8 months ago 2 Members · 1 Reply

  • fda
  • stability
• 1 Reply

• 

  Microformulation

  Member

  March 11, 2020 at 5:15 pm

  https://cptclabs.com/stability-testing/

Log In to Reply