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...
by RJTimko | Oct 18, 2017 | Knowledge Management
In the development of a dosage form for a new or generic chemical entity, a formulator generally relies on his past experiences to assist him in making decisions. These past experiences can vary with the knowledge and experiences of each individual formulator. ...
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...
by RJTimko | Oct 2, 2017 | Control Strategy
Control Strategy is a critical concept in formulation and process development and the manufacture of a drug product. The control strategy plays an important role in ensuring that the Quality Target Product Profile (QTPP) is realized and the Critical Quality Attributes...
by RJTimko | Sep 28, 2017 | Processing
Extended in process hold times for drug product intermediates could have an overall impact on the commercial ‘shelf-life’ (not expiry date) of your product. Establishing Date of Manufacture According to FDA, a 30-day period from the Date of Manufacture to the...
