Example: air traffic controller
Setting Dissolution Specifications
Found 2 free book(s)
Management of Out of Specification (OOS) for Finished Product
impactfactor.orgresults. OOS results are most often generated due to laboratory or manufacturing-related errors, the setting of inappropriate specifications, or poor method development. Materials and Methods: The current work is an effort to deliberate several aspects of finding the root cause for the OOS during the finished product analysis by using HPLC.
Guideline on quality of oral modified release products
www.ema.europa.eudissolution rate over time (per cent of label claim per hour) for a given interval should preferably be established (see also section 2.2). For this type of product, a graphical presentation of the dissolution rate versus time should be additionally presented in order to justify that the product c an be regarded as a