We adopted our cGMP standard way ahead of the deadline given to us by the US FDA because we believe that quality is the way of success. In fact, we are proud to be part of creating analytical methods for Indian herbal pharmacopeia by Indian Food and Drug Administration.
R and D lab
Our expert QC people handle our in-house laboratory furnished with excellent equipment like high-performance liquid chromatography (HPLC) and high performance thin layer chromatography (HPTLC) for purity and impurities along with other non-specific colorimetric methods such as UV-Vis spectrometry, atomic absorption spectroscopy, inductively coupled plasma-mass spectrometry (ICP/MS) for elemental analysis, gas chromatography (GC), liquid chromatography/mass spectrometry (LC/MS) for trace compounds and pharmacokinetic analyses.
All the herbs we use for extraction are identified and certified for the correct species in our lab, Standard Herbarium Centers and CSIR labs. Herbal Authentication and Traceability of Herb and Herbal Reference Extract are a part of our quality control measures.
Our quality control assures the right quality at various steps of manufacturing. And our QA department makes final checks for the following tests before giving release:
- Assay of standard by HPLC, HPTLC and/or GC
- Physical parameters like color, taste, identification, particle size, solubility etc.
- Impurities checks for Heavy metals, Organic volatile impurities, fertilizer and pesticides, organic solvents and related substances
- Microbiological counts for total plates, E. Coli, S. Aureus, P. Aseudomonas, Yeast and Molds
Our quality assurance team monitors the quality of the products right from the raw material procurement stage to the expiry date of the finished product.
If you appreciate the highest quality standard, you can rely on Orgenetics.