Quality & Compliance for Sublingual ODF

GMP Documentation

URS, SOPs, batch records, CoA, deviation/CAPA management; GDP-aligned records for every ODF lot.

Validation (IQ/OQ/PQ)

Equipment IQ/OQ, process PQ, cleaning validation, and analytical method qualification for uniform dose delivery.

Stability & Release

ICH stability protocols, moisture uptake profiles, disintegration and assay testing, microbial limits and packaging integrity.

In-Process Controls for Oral Dissolving Films

Viscosity and solids content of casting slurry
Basis weight & thickness uniformity across the web
Drying temperature/humidity profiles and residual solvent/moisture
Content uniformity, tensile strength, and friability