Manufacturing, Production, and Quality Control

Once a drug formulation passes initial tests, it moves on to manufacturing and quality control evaluation. Pharmaceutical manufacturers test critical quality attributes (CQAs) and identify the critical material attributes (CMAs) which must remain stable throughout production and until the drug reaches consumers. End user satisfaction also depends upon drug delivery and packaging, which must be tested to eliminate damage to the products. Quality control testing detects any batch-to-batch variation, and manufacture troubleshooting and root cause analysis helps manufacturers identify issues in their process.

Rheology measures critical attributes such as viscosity of injectables as well as viscoelasticity and yield stress of topicals, all which impact drug delivery. Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA) detect thermal stability and product changes, aiding in process and delivery optimization.