Formulation and Quality
2019 PharmSci 360
o With insights into interpretation of Pharmacopieal Mandatory Vs Non-Mandatory tests to ICH Q12(draft), Guideline on Established conditions; Learn how DFE Pharma can facilitate you in setting smart specifications for excipients and finished products to cover your finished product Lifecycle.
o Furthermore, DFE complements and mitigates excipient variability risks with In-house trending program (MVA/PCA).
o We are committed to share an annual Product consistency document summarizing data spread for entire production knowledge space. This is valuable information than the usual practice of verifying excipient variability using either 3 batch or even 10 batch samples! We are confident of having excipient produced operating at center spec backed with strong process capability/operations and monitored by Statistical control.