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What is a difference between GMP and WHO - GMP/cGMP

Writer's picture: Jesante OrganicsJesante Organics

GMP & cGMP are same and are main requirement of Domestic Market. cGMP is "current Good Manufacturing Practices". In current world, daily there are some or the other guidelines coming up / updated on daily basis (for particular product/process/....etc) and there is NO separate version of GMP guidelines (i.e. we donot obtain GMP/cGMP certificate as "GMP Certificate 2012" or "cGMP Certificate 2012", etc. Only the DATE of obtaining the Certificate is mentioned). So it is the Pharmaceuticals companies who are required to follow GMP on each every step, on daily basis and also are required to be updated as per latest GMP norms. Therefore FDA has included the term "Current" in GMP i.e. cGMP. WHO-GMP is for EXPORT Market. This is also issued by FDA only and is required for products being Exported. Foreign countries demand for WHO-GMP alongwith COPP. "COPP is Certificate of Pharmaceutical Product". COPP indicates that manufacturer has followed GMP practices for Particular Product being Exported i.e. starting from RM & PM entry ....... till ....... final end product Quality release. Because in a manufacturing unit, companies manufacture more than 1 products and of various dosage forms (Tablet, capsule, ointment, syrup, etc). Companies donot Export all the products being manufactured in that particular Unit (Some are for Domestic Market and some are for Export Market). Therefore FDA audhority of Exporting counties come and audit for particular products and demand for WHO-GMP alonwith COPP. Thus WHO-GMP alongwith COPP is mandatory for EXPORTs

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