GMP - WHO Certification In Mumbai - Mumbai

GMP - WHO Certification In Mumbai
The term GMP was introduced to regulate manufacturing and packaging operations in the pharmaceutical company. Until the mid-1960s, operating procedures for the manufacture of drugs consisted of formulae and the basic methods of making products. A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
WHO GMP guidelines are primarily used by pharmaceutical regulators in developing countries; these are less strict than European or US GMP standards. GMP standards in other countries such as Australia, Canada, Japan, Singapore, Russia. A good Manufacturing Practice (GMP) guideline of World Health Organization (WHO) is being compulsory in Nepal. The Drug Administration Department of Nepal is working on development of policy and on its enforcement it is applicable to all existing and new pharmaceuticals industries in Nepal.
The WHO makes also suggestion on regulatory actions in the case of non-compliance. These include the requirement of correction of unsatisfactory situations, product recall and in extreme cases withholding the authorization and closure of a factory. The final decision about corrective actions, however, depends on national regulation of individual states.
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