CDSCO-Ahmedabad became first ISO certified National Regulatory body in India

  • Posted on: 25 February 2015
  • By: PharmaTutor News

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CDSCO Ahmedabad became first ISO certified national regulatory body in India. The office of the Deputy Drugs Controller (India), CDSCO, Ahmedabad was audited on 10th february by the nominated auditor of notified body and certified it ISO 9001:2008 certificate.

CDSCO, Ahmedabad office is engaged in the administration of various provisions of Drugs & Cosmetics Act and Rules, and other non - statutory functions like processing of applications for grant or renewal of licenses for manufacture of Vaccines and Sera, r-DNA Products, Large Volume Parenterals, Medical Devices, Blood Banks, and approval of Public Testing Laboratories; Drawing of samples of drugs and cosmetics to evaluate quality; Issuance of NOC for Bill of Entry, Shipping Bills, Export of Drugs and Dual Use Items; Issuance of Test license in Form - 11.; Recommendation for issuance of Certificate of Pharmaceutical Product (COPP) as per WHO GMP guidelines, Written Confirmation as per EU Norms, and approval of BA/BE Centre.

As this office is involved in the public dealing for above mentioned services in day to day operations, it was proposed to implement Quality Management System (QMS) to achieve public satisfaction by optimum utilization of resources as per ISO 9001:2008 standards.

ISO Standards will increases effectiveness and efficiency of the organization through continual improvement in system and services, improve risk management through greater consistency and traceability of services.
It will also improve operational efficiency and effectiveness of the organization by encouraging well defined and documented procedures;  Public satisfaction through delivery of servi ces that consistently meet their requirements; Increases employee motivation as work process will be well defined and; Improved stakeholder’s relationship.

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