STABILITY STUDIES

Molecules deemed promising as Probable Candidates for API/ Pharmaceutical Formulation during the Drug Discovery Process are exposed to Stability Testing, which is Integral to  ¹develop [the development of New Drug Candidates] i.e., APIs and Pharmaceutical Formulations/Products for establishing their Shelf Life or Expiry Date. [The] ²Influence or possible interaction of Packaging Material with Drug Products during Shelf Life Period should also be studied.

³It is also important during Routine Manufacturing Process to monitor Product Quality with respect to Time and Environmental Conditions. [It is also important to monitor Product Quality with respect to Time and Environmental Conditions during Routine Manufacturing Process.]

As per ICH Guidelines, our Stability Storage Facility is ⁴equipped with Stability Chambers controlled by 21 CFR Part 11 Requirements with Online Temperature and RH Data Recording, Auto Alarm, and Mobile Text Warning [equipped with Stability Chambers with Online Temperature and RH Data Recording, Auto Alarm, and Mobile Text Warning Facilities in accordance with 21 CFR Part 11 Requirements]. ⁵We cover [EFRAC covers] a wide range of Environmental Conditions such as:

Refrigerated Condition 5°C

Primary ICH Long Term Condition (For Zone I to II) 25°C/ 60% R.H

Intermediate ICH Condition (For Zone Ivb)  [1vb] 30°C / 75% RH

Intermediate ICH Condition (For Zone I to Iva) [1va] 30°C / 60% RH

⁶At EFRAC we tries [EFRAC delivers] to deliver the best quality services to our customers. Our innovative and strategic layouts are designed to guide the global Pharma industries towards guaranteed Product Safety, Superior Quality at minimized risks.