Source : ePharmail of Pharmabiz.com. For more info, visit http://www.pharmabiz.com.
April 04, 2009, 0800 IST
The department of Ayush has issued a notification on supplementary guidelines for manufacturing of Rasaushadhies or Rasamarunthukal and Kushtajat (Herbo-mineral-metallic compounds) of Ayurveda, Siddha and Unani (ASU) medicines in the country. The supplementary guidelines are to provide general and minimum technical requirement for quality assurance and control in manufacturing Rasaushadhies or Rasamarunthukal and Kushtajat.
These guidelines deal with Bhasmas, Sindura, Pishti, Kajjali, Khalviya Ras, Kupipakwa, Rasayan, Parpati, Potali Rasa, Satwa (of metals and minerals origin) Druti Parpam, Karpu, and Kushta etc used in ASU systems of medicine.
The supplementary GMP guidelines for Rasaushadhi or Rasamarunthukal and Kushtajat are needed to establish the authenticity of raw drug, minerals and metals, in-process validation and quality control parameters to ensure that these formulations are processed and prepared in accordance with classical texts and for which safety measures are complied. Only those manufacturing units which have GMP for ASU drugs and supplementary certificate for Rasaushadhies or Rasamarunthukal and Kushtajat formulations shall be allowed to manufacture the same. Supplementary GMP certificate for Rasaushadhies shall be issued by the State Licensing Authority only after thorough inspection by an expert team including Rasashstra experts nominated by the department of Ayush.
As per the supplementary guidelines, the manufacturing area of Bhasma and Kupipakawa and Rasaushadhi preparations made from metals and minerals should be completely segregated from the production area used for preparation of plants and animal byproduct based formulation to avoid cross-contamination. The guideline specifies the minimum amount of areas that the manufacturers have to use for each and every stages of manufacturing the medicines. For instance, there should be a minimum 100 sq ft of space for Bhatti or heating devise section and grinding, drying and processing section separately for Bhasma and Rasaushadhies.
As per the guidelines, the manufacturers have to keep a Shodhan Register for ready reference, providing even minute details. For quality control, the guidelines specify that the specifications for finished Rasaushadhi are primarily intended to define the quality rather than to establish full characterization, and should focus on those characteristics found to be useful in ensuring the quality. Consistent quality for Rasaushadhi can only be assured if the starting material-metals and minerals are used of pharmacopoeial standards. In some cases more detailed information may be needed on aspects of their process. The manufacturers will ensure in-house standards for the uniform quality of product.
Quality testing will be carried out as per official Pharmacopoeia or Schedule books for texts namely, colour, taste, varitaratwa, Rekhapurnatwa, Laghutva, Nirdhumatwa, Dntagre Kachakacha, Niruttha, Apunarbhava and Nischandratwa.
The Particle size of the product should be tested by adopting microscope fitted with micrometer or particle size analyzer or any appropriate other techniques. Required physio-chemical characterization of the product should be undertaken by appropriate analytical equipment. The Standard Manufacturing Process of the product should be evolved/follow up. The disintegration time of pills-vati and tablets should also be recorded.
Like this:
Be the first to like this post.
I really find this is a great interesting subject. Never looked over this subject in this way. If you are planning to create more articles relating to this subject, I will be back soon!