There are over 30 quality control checks from the starting material to the finished product. This is Maruti’s distinguishing attribute and forms the basis for a reliable manufacturing process and high-quality products that differentiate us in the marketplace.
Maruti is committed to continuous improvement of Quality Assurance methods and is actively engaged in helping define the regulatory environment.
Our robust QA system ensures quality is built into our products, starting with good agricultural and collection practice (GACP) during cultivation, then growing and finally harvesting of the plant.
At MFPL, the quality of our products is controlled during every stage of the manufacturing process by adhering to strict Good Manufacturing Practices (GMPs) and extensive testing. Every process that has an impact on the product quality is precisely documented, and available for review by our customers and regulatory authorities.
The quality of the base herbal material is an essential pre-requisite, as it can affect the subsequent phases in the process. Hence Good Manufacturing Practices (GMP) is applied at each and every step to ensure enhanced characteristics of the final product. In addition to GMP, other measures applied at this stage are:
- GACP (Good Agricultural and Collection Practices)
- Area Selection
- Control Of:
- Harvesting period and harvesting method
- Drying conditions
- Botanical Identification of the plant or a part of a plant
- Quarantine Of the Biomass under monitored conditions
- Micro biological Analysis
- Chemical Analysis
- Control of Contaminants, including pesticides, aflatoxins, heavy metals
Prevention of Errors and tight Controls
All the raw data is recoded, ever critical procedure and are thoroughly described for workers and double-checked through BMR’s Batch Manufacturing Records
Manufacturing Process includes controls on
- Extraction process parameters including
- Solvent type
- Extraction conditions (time, pressure and temperature)
Check and then check again
The finished product undergoes final analysis and documentation review which ensures compliance with specifications. To achieve this, leading-edge technology and analytical instruments are employed -including HPLC and NMR, according to suitably validated analytical methods.
Qualified analytical reference standards are used, and all data is summarized in the Certificate of Analysis. All analytical data is maintained for future reference.
The final stage involves quality assurance/quality control review including
- BMR documentation review
- Analytical controls including:
- Content of active principles
- Content of impurities
- Heavy Metals
- Residual solvents
- Physical Analysis
- Microbiological analysis of the final product
Additionally, laboratory equipment qualification and periodical maintenance are assured.