botanical standardization, quality control

Quality Control

Wet Chemistry

Classical Wet Chemical analysis was the only truly definitive means of chemical/pharmaceutical analysis for over a century. Advances in instrumentation and a reliance on matrix matching standards has gained importance but cannot replace these classical methods that are highly accurate and definitive, independent of any references. These methods are validated and easily reproducible in any laboratory.

Instrumentation

One of the industry’s foremost Quality Control Laboratory, this facility is equipped with multiple HPLC’s, UV-Vis Spectrophotometer’s, HPTLC with Photo-documentation, Atomic Absorption Spectrophotometer, Analytical Microbalances, Polarimeter’s, Ultrasonic extractors and every important analytical tool.

Data Archiving / Reporting

Amsar complies with and exceeds every requirement of the GMP norms. All analytical reports are archived including work sheets, calculations, primary registers, final registers and finally computerized reports. All control samples are kept on record for 3 years.

Microbiology

One of the industry’s few in-house Microbial laboratories, we monitor every batch manufactured and sold. U S Pharmacopoeial standards are the benchmark and highly qualified microbiologists ensure that the assays are performed according to accepted norms. The laboratory monitors process water, effluents and treated waste water, environmental swabbing is done to ensure contamination free production environs.

Librarian Services

Over 40 years of collecting magazines, books, journals, articles etc has resulted in a vast resource of valuable and sometimes rare literature ranging from traditional Tibetan formulas to the latest articles in Pharmacology, Phytochemistry, Microbiology etc. Amsar maintains a rare interest in literature that is normally reserved for academia and we encourage all our staff to participate in collective readings and brainstorming sessions.

Over 7500 sft of dedicated Quality Control laboratories that include Wet Chemistry, Microbiology, Instrumentation , Librarian services, Data archiving/reporting is the heart of Amsar’s operation. A total SOP driven process with compulsory validation of all methods and processes guarantee’s the highest quality of reporting with transparency and a 5 year batch control. All our chemists and technologists are certified by the Drug Control Department of India for carrying out analysis as required by a modern Quality control Laboratory for botanical standardization.

Beyond the Norms:

In an industry where a majority of buyers rely entirely on supplier claims, we remove any doubts by offering Chromatographic fingerprints and batch analysis reports that reflect not only the extract that you buy, but also the crude herbs that were used to manufacture the extracts. HPTLC & HPLC profiles guarantee authenticity of the extracts and prove an absence of cross contamination. Each batch of finished product bears the record of its journey in and through our manufacturing/ analytical processes. These are computer coded, and kept on record for 5 years. At Amsar, crude herbs are sourced from cultivators and ethnobotanists and these alliances that go back nearly 50 years ensure that the herbs we buy are authentic and of the best quality. Crude herbs are dried and stored according to our protocols and contain the entire spectrum of bioactive compounds.

A testament to this commitment is the country’s only award handed out for Quality of extracts to a manufacturer in India.

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