ANDA submission batch samples should be stored for 1 year after approval of the ANDA and samples of the drug product used for bioequivalence studies must be stored following the requirements listed in 21 CFR 320.38 and 21 CFR 320.63.
Category: Pharmaceutical Blog
Q1 Scientific staff attended the recent training course on Stability Testing in Pharmaceutical Development and Manufacturing, held in Amsterdam on 5-6 June 2014. Topics covered included ICH guidelines, QbD, ASAP and photostability
The Q1 Scientific facility is fully supported with a back up power generator, which cuts in automatically in the event of electricity loss resulting from any ESB strike. Each environmental chamber operates independently, with separate temperature and humidity controls and all chambers are continuously monitored by a computerised monitoring system with back up alarms and … Continued
According to proposed new EU guidelines which seek to amend current Directive 2001/83/EC on Medical Devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, it is suggested that there will be increased requirement for evidence of stability testing medical devices. Manufacturers of Medical Devices … Continued
The FDA have issued a New Stability Guidance document earlier this month for ANDAs which now requires stability data on three batches to be generated as opposed to one batch which was the case up to now. Over the past few years, the Office of Generic Drugs (OGD) has received numerous inquiries about what stability … Continued