KSM-66 Ashwagandha    

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Quality Control and Quality Assurance

THE MAKING OF KSM-66 ASHWAGANDHA



AN OVERVIEW OF IXOREAL'S COMMITMENT TO GACP, GMP, cGLP AND QUALITY ASSURANCE


GOOD AGRICULTURAL AND COLLECTION PRACTICES (GACP)

The ashwagandha root contains a variety of bio-active constituents. Different geographic locations determine the amounts and ratios of bio-active compounds in the ashwagandha root. Depending on soil conditions, the withanolide content in the ashwagandha root varies. The lower grade and older root stock is virtually useless and therapeutically, shows poor response. At Ixoreal, only high grade ashwagandha roots from the best geographic location are sourced. The herb requires well drained, sand loamy or light red soils with pH of 7.5-8.0. Ashwagandha is a late rainy season crop and requires relatively dry season. Areas receiving 650-750 mm rainfall are best suited for its cultivation. The state of Rajasthan in India is one of the most suited terrains known to grow the best quality ashwagandha in the world and that is where, our ashwagandha farms are located. The roots of ashwagandha are cultivated organically. No old root stock is used. Only special or High A-grade root pieces are used for the extraction. These roots are solid and bright, up to 7 centimeter, approximately and with a diameter of 1 to 1.5 centimeters.


CURRENT GOOD MANUFACTURING PRACTICES (cGMP)

Ixoreal stringently follows WHO and US-FDA guidelines on GMP. We invite our valued business partners for a tour of our state-of-the-art manufacturing unit, located at the Government of Andhra Pradesh (India) allocated Pharma zone. Our KSM-66 Ashwagandha processing is based on ‘Green Chemistry’ principles and ensures an effective overall approach to product quality control and risk management. We have set internationally approved standards and practices for product testing, manufacturing, storage, handling and distribution. Ixoreal firmly believes in offering a safe and effective product and therefore does not compromise on systems and documentation. All bulk and raw products are stored in quarantine before being subjected to KSM-66 Ashwagandha processing. To ensure KSM-66 Ashwagandha’s consistency and high quality and to prevent raw material and pre-finished material from being adulterated, contaminated or spoiled, Ixoreal, has established manufacturing controls at every stage.

KSM-66 Ashwagandha processing is done in exclusively designed clean room systems. Our internal manufacturing controls provide documented proof that correct procedures are consistently followed at each step of processing and every time a batch extraction is made. Extensive controls cover the sanitation and hygiene of our facilities, personnel, utensils and machinery are strictly ensured. Controls are also in place for handling materials through out each step of the production process, such as work sheets, assuring consistency from batch-to-batch, easy monitoring and averting any chances of contamination and adulteration.


CURRENT GOOD LABORATORY PRACTICES ( cGLP)

Ixoreal subjects KSM-66 Ashwagandha to various internationally prescribed quality standards in its state-of-the art laboratory. All raw and finished material is inspected by the in-house quality control unit. Freshness labeling guidelines are followed. Trained and qualified personnel handle all the material, from raw stock to finished product. Based on client requirements, Ixoreal also offers to get its product tested in independent testing laboratories anywhere in the world. We welcome third party verification of our analytical reports. In short, Ixoreal Quality Control & Quality Assurance stages include:

  • Quality on the farm
  • Quality on receiving the raw material
  • In-house laboratory testing and segregation of raw material,
  • Organoleptic testing
  • Moisture content analysis
  • Microscopy and petri-grid analysis
  • Microbiological testing
  • Ash testing
  • pH testing
  • Aflatoxin testing
  • Heavy metal analysis
  • Pesticide analysis

Every sample and every dispatched batch is accompanied by certificate of analysis (COA).


GOOD PACKAGING PRACTICES (GPP)

Strict protocols are followed at every stage- from storing of raw herb to finished product. Precise labeling and hygienic handling are ensured. KSM-66 Ashwagandha packaging is done as per the Standard Exports Packaging policy.