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

More documents

Recommendations

Info

Wherever possible and applicable Particle size of the product may be tested adopting microscope fitted with micrometer or particle size analyzer or such other techniques. 4. Product recalls:- The product recall procedure should be related to and depends very much on the existing regulation. Standard operating procedures (SOPs) should be included for storage of recalled Rasaushadhi in a secure segregated area, complying with the requirements specified for storage, while their fate is decided. 5. Self-inspection:- At least one member of the self-inspection team should possess a thorough knowledge on Rasashastra (production and quality control testing of Rasaushadhi). 6. Personnel:- The release of Rasaushadhi should be under the authority of a person who has been trained in the specific features of the processing and quality control of Rasaushadhis. Personnel dealing with the production and quality control of Rasaushadhis should have an adequate training in the specific issues of Rasaushadhis. 7. Training:- The personnel should have adequate level of training in appropriate fields such as Rasa shastra- Bhaishajya Kalpana, pharmaceutical technology, mineralogy, pharmacology of metals and minerals, inorganic medicinal and pharmaceutical chemistry, Pharmacognosy, hygiene, microbiology, and related subjects (such as traditional use of herbal medicines). Training records should be maintained and periodic assessments of the effectiveness of training programmes should be made. 8. Reference samples and standards:- In the case of Rasaushadhis, the reference standard may be a mineralogical sample of the minerals and metals, a sample of the prepared Rasaushadhi, processed metals and minerals e.g. Bhasma, Kajjali, etc. All reference standards should be stored under
appropriate conditions to prevent degradation. Their expiry and/or revalidation date should be determined and indicated. 9. Documentation:- The system of documentation devised or adopted should have as its main objective to establish, monitor, and record quality for all aspects of the production, quality control and quality assurance. 10. Stability studies:- The Rasoushadhis are described as having no specific shelf life. However, inhouse validation of the product should be done once in 3 years to ensure the desired quality. Samples used for stability studies should be stored in the containers intended for marketing. 11. Packaging materials and labeling:- In addition to the Rule 161 of the Drugs & Cosmetics Rules the following information should be provided in the label. There should be adequate information on the label (or in package insert) informing the users of the composition of the product (in addition to the brand name, if any), indications or actions, directions for use, cautions and adverse reactions if any, and the expiry date. 12. Dosage form of Rasoushadhi:- In order to have equal quantity of Rasoushadi having different individual doses. the Rasoushdhi may be made into an acceptable dosage form such as Tablet/Pill/Capsule after adding suitable fillers or binding agents. In such cases the label must indicate the quantity of medicine and filling material added in each case. The crystalline product may be grinded before packing in the individual size.
Page 1 and 2: (To be inserted under Schedule-T -
Page 3: 5. Book Reference followed 6. Metho

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?