The QP must ensure two points when an authorised ATMP is imported from a third country: firstly, that each batch has been manufactured in accordance with Good Manufacturing Practice and secondly, that the quality complies with the conditions of marketing authorisation.
LVA provides a wide range of support in this area:
- EU import & QP services for medicines (human, veterinary, etc.)
- Final inspection for batch release & certification according to the pharmacopoeia and the specific product
- Quality control
- GMP/GLP-certified and FDA-tested/approved
- For APIs, excipients, finished pharmaceutical products
- Dissolution rate testing
- Elemental impurities
- Particle analysis
- Amino acid analysis
- Microbiological analysis
- Physical-chemical testing
- General identification tests (IR, TLC, HPLC, UV/Vis)
- Assay (UV/Vis, AAS, titration, HPLC with multiple detectors, UPLC, GC, GC/MS, LC/MS) and content uniformity
- Identification and quantification of related substances (GC, HPLC, GC/MS, LC/MS)
- Physical determinations (pH, viscosity, density, polarimetry, refractive index, melting point, osmolality)
- Moisture (Karl Fisher, loss-on-drying)
Method development & validation or verification are also carried out. Where requested, we also adopt the method used in the original laboratory.
