Pharma Guide 2013 Pdf Free Download

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Modern Pharma is a leading fortnightly business magazine in India, catering to the pharmaceutical industry. Published by Network 18 Ltd., it covers the latest industry trends…



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“A revised version of the “Guidelines on Good Distribution Practice of Medicinal Products for Human Use“ was published in the Official Journal and is applicable as of 24 November 2013 (OJ C 343/1, 23.11.2013).

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starting with the qualification of equipment employed, the adaptation of ICH guide- lines to the early stages of drug development, the relation between analytical vari- ability and specification acceptance criteria, the continual assessment of the perfor-

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Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the quality of

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