The department of Ayush has issued the procedural Guidelines for inspection of ayurveda, siddha and unani (ASU) drug testing laboratories. It is an inspection manual for the inspectors for approval of drug testing laboratory under Rule 160 A-J of Drugs & Cosmetics (D&C) Rules-1945.
This inspection manual covering various aspects about the qualifications, duties and responsibilities of inspectors will be a much needed and helpful guide for orientation of ASU inspectors for proper discharge of their duties under D&C Act and Rules thereunder. The inspection manual of drug testing laboratory is especially explained in detail for development of insight of the inspectors regarding interpretation and implementation of the Rules.
Role of state licensing authority in facilitating such inspection is explained keeping in view of essential points to be focused while forwarding the application for joint inspection to the central government. It also includes the list of recommended equipment required for carrying out analysis of ASU drugs and raw materials. The manual also touches upon various essential books that may be required for testing of ASU drugs. This inspection manual is not a substitute of the D&C Act 1940 and Rules thereunder but this manual is expected to help state licensing authorities to augment the regulatory capacities of inspectors and in developing master trainers as well.
This manual will prove to be useful and handy for regulatory inspectors assigned with the duty of assessing the infrastructure and functionality of drug testing laboratories and for imparting necessary training to the officials engaged with quality control responsibilities. It will also help in bringing objectivity and transparency in inspections and preventing arbitrary inspection reports.
Earlier, a provision in the D&C Rules, 1945 was made on January 31, 2003 for approval of laboratories for carrying out tests on ASU drugs and raw materials used in their manufacture. The inspectors designated by the central and state government jointly inspect such laboratories to verify that requisite regulations are complied, before recommending for approval.
This manual will facilitate better understanding amongst the inspectors and licensing authorities about the provisions of D&C Rules, 1945 relating to the procedure for approval of drug testing laboratories of ASU drugs and thereby its proper implementation. It will bring uniformity, objectivity, transparency and harmonization in the procedure of inspection and approval of laboratories as per legal provisions. The manual also brings out the provisions of D&C Rules, relating to inspectors of ASU system in a lucid way.
Source:Pharmabiz
This inspection manual covering various aspects about the qualifications, duties and responsibilities of inspectors will be a much needed and helpful guide for orientation of ASU inspectors for proper discharge of their duties under D&C Act and Rules thereunder. The inspection manual of drug testing laboratory is especially explained in detail for development of insight of the inspectors regarding interpretation and implementation of the Rules.
Role of state licensing authority in facilitating such inspection is explained keeping in view of essential points to be focused while forwarding the application for joint inspection to the central government. It also includes the list of recommended equipment required for carrying out analysis of ASU drugs and raw materials. The manual also touches upon various essential books that may be required for testing of ASU drugs. This inspection manual is not a substitute of the D&C Act 1940 and Rules thereunder but this manual is expected to help state licensing authorities to augment the regulatory capacities of inspectors and in developing master trainers as well.
This manual will prove to be useful and handy for regulatory inspectors assigned with the duty of assessing the infrastructure and functionality of drug testing laboratories and for imparting necessary training to the officials engaged with quality control responsibilities. It will also help in bringing objectivity and transparency in inspections and preventing arbitrary inspection reports.
Earlier, a provision in the D&C Rules, 1945 was made on January 31, 2003 for approval of laboratories for carrying out tests on ASU drugs and raw materials used in their manufacture. The inspectors designated by the central and state government jointly inspect such laboratories to verify that requisite regulations are complied, before recommending for approval.
This manual will facilitate better understanding amongst the inspectors and licensing authorities about the provisions of D&C Rules, 1945 relating to the procedure for approval of drug testing laboratories of ASU drugs and thereby its proper implementation. It will bring uniformity, objectivity, transparency and harmonization in the procedure of inspection and approval of laboratories as per legal provisions. The manual also brings out the provisions of D&C Rules, relating to inspectors of ASU system in a lucid way.
Source:Pharmabiz
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