cGMP AUDITS AND COMPLIANCE
Facts about the cGMP AUDITS AND COMPLIANCE ? cGMP stands for Current Good Manufacturing Practice regulation enforced by the US Food and Drug Administration (FDA). India has become a priority location for the USFDA as it houses the largest number of FDA-approved drug manufacturing plants outside the US. India with its Rs.1.1 trillion drug industry, which largely makes generics, exported around Rs.50,000 crore of drugs in 2016-2017. USFDA has increased the number of inspections at FDA approved units. The number of FDA 483 and warning letters,import alerts issued to pharmaceutical companies globally, have risen over the years and have been asked to review and strengthen its CAPA (Corrective Action Preventive Action) practices. Why Audits observation CAPA ? CAPA: CAPA stand for Corrective and Preventive Action. FDA and regulatory agencies are looking closely in how Pharmaceutical companies conduct their investigat...
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