by RJTimko | Jan 11, 2018 | Stability
The blending of different ingredients together in a uniform mixture is one of the most basic of pharmaceutical unit operations, but it can also be one of the most challenging to control. The terms ‘blending’ and ‘mixing’ are often used interchangeably, but...
by RJTimko | Nov 16, 2017 | Stability
Starting Materials are the building blocks by which drug substances are assembled. Starting Materials must consistently meet their specifications. However, Starting Materials do not need to be prepared in compliance with GMPs. There are no absolute requirements for...
by RJTimko | Nov 13, 2017 | Stability
In submitting stability data in a NDA, there is the primary data which are generated on the drug substance and drug product prepared by the proposed commercial synthesis/process and proposed commercial formulation/manufacturing process, respectively. In addition,...
by RJTimko | Oct 12, 2017 | Stability, Thermal Cycles
These studies are designed to complement pre-formulation and routine ICH Q1A Registration Batch Stability Studies. ICHQ1A states that the data from accelerated stability studies can be used to evaluate the effect of short-term excursions higher or lower than label...
