Regulatory Focus™ > News Articles > India Issues Draft Drug GDP Guidance

India Issues Draft Drug GDP Guidance

Posted 14 January 2013 | By Ansis Helmanis

India's Central Drug Standards Control Organization (CDSCO) released on 10 January 2013 draft guidelines on good distribution practices (GDP) for pharmaceutical products intended to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process.

Elements of the process include, but are not limited to, procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices.  The draft guideline is similar to the GDP guideline for biological products that went into effect on 8 October 8 2012. 

A core component of the draft is the establishment, definition and maintenance of a quality control structure complete with specific delegations of authority.  Personnel should be adequately trained in product handling, product testing, sanitary procedures and supply chain integrity procedures.  Comments are due by 31 January 2013.

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