We adopted our cGMP standard far ahead of the guidelines proposed to the industry by the US FDA. The reason is simple: we believe that quality is the way of success. In fact, we are proud to be part of creating analytical methods for the Indian Herbal Pharmacopeia by the Indian Food and Drug Administration.
Our expert QC technicians handle our in-house laboratory, which is furnished with state of the art equipment like high-performance liquid chromatography (HPLC) and high performance thin layer chromatography (HPTLC). Alongside are 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.
Every plant species we use for extraction is identified via HPTLC botanical fingerprinting, 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 QC managers assure the quality standards are met at various steps of the manufacturing process. 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 check 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 ingredients right from the procurement stage to the expiry date of the finished ingredient.
If quality is a priority, you can rely on Orgenetics.