by RJTimko | Jan 22, 2024 | Quality
Introduction Drug Product Quality is a term one should be familiar with as part of routine drug development and manufacture. Recently while working with a small pharmaceutical company and their contracted development organization, an Incident Report documented the...
by RJTimko | Oct 25, 2017 | Quality
It is a simplistic analogy, think of formulation and process development in terms of developing the recipe for a cake. The result should mimic a packaged cake mix, which includes or lists all the ingredients required and provides complete yet simple instructions. By...