PREPARATION & COMPILATION OF ACTD DOSSIER (PART II QUALITY)

ACTD is a critical document for drug substance and produces registration in ASEAN region. The document is essentially divided into 4 parts. Each part provides information under specific head. Out of all the parts, the part II is most important. This part not only evaluates technical suitability of the product but also determines the suitability of active drug and Excipients. The major stress in this part is on formulation, manufacturing, stability and process validation. The information required under this part is suitably detailed in this article.