At a Glance
We analyse a wide range of raw materials, active ingredients, intermediates, finished products, containers, environmental factors and much more for companies in the pharmaceutical industry. All laboratory services offered in this area satisfy the requirements of the most important pharmacopoeias Ph.Eur. and USP (optionally BP and JP).
Our long-standing know-how in pharmaceutical analyses extends to the following product groups:
- Human medicines
- Veterinary medicines
- Herbal medicines and herbal medical products
Batch Release Testing
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.
Analyses on behalf of the pharmaceutical industry are always performed under strict quality assurance measures. In addition, the Qualified Person at LVA is authorised to issue and approve analysis certificates.
- Conformity of the batch and its manufacture with the marketing authorisation
- Assurance that manufacturing was in compliance with EU GMP
- Validation of the manufacturing and testing procedures (by means of audits)
- Review of deviations and changes in production and quality control
- Checking of batch records for completeness, integrity and conformity