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(To be inserted under Schedule-T - GMP) - amam-ayurveda.org

(To be inserted under Schedule-T - GMP) - amam-ayurveda.org

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Depending on the formulation <strong>be</strong>ing manufactured, manufacturers may adopt aerobic<br />

or anaerobic process. Properly baked and clean earthen pots and glass containers of<br />

appropriate design should <strong>be</strong> used.<br />

The manufacturing area should <strong>be</strong> designed with special attention to processing of<br />

products that generate toxic fumes like SO2, arsenic and mercury vapor etc. When heating<br />

and boiling of the materials is necessary suitable air exhaustion mechanism should <strong>be</strong><br />

provided to prevent accumulation of unintended fumes and vapors. Such areas may <strong>be</strong><br />

provided with properly designed chimneys or ducts fitted with exhaust system and suitable<br />

scrubbing system to remove fumes and smoke, so that safety of personnel and environment is<br />

taken care of.<br />

Since processing of Rasaushadhi may generate heavy metal contamination and cross<br />

examination, cleaning of equipment is particularly important.<br />

Records shall <strong>be</strong> maintained specially for temperatures attained during the entire<br />

process of Bhasmikaran while employing furnaces using oil, gas or electricity. Appropriate<br />

temperature measuring instrument should <strong>be</strong> employed such as pyrograph for manual<br />

reading/recording or heat sensors connected to computer as the case may <strong>be</strong>.<br />

personal.<br />

Access to manufacturing areas shall <strong>be</strong> restricted to minimum num<strong>be</strong>r of authorized<br />

3. Quality Control:-<br />

A. Process Quality Control:-<br />

The registers as indicated <strong>be</strong>low should exclusively <strong>be</strong> maintained for ready reference:-<br />

a. Shodhan Register with following details:-<br />

1. S1.No.<br />

2. Batch No. & Size<br />

3. Name of the Raw-material with Quality reference<br />

4. Quantity of Shodhana Dravya

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