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Stated in the preamble to the CGMP regulations for finished drug products that these regulations will be used as guidance for the manufacture of BPC s. It should be emphasized that the manufacturing process or storage condition is responsible for producing particular polymorphs or solvates the control methods merely determine the outcome. Complex esters where both the alcohol and the acid result from several-step syntheses are acceptable. Inorganic components used in fermentations should meet...
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You hello ladies and gentlemen and welcome to global compliance panels live webinar on the 510 K submission requirements contents and options my name is michael and i'll be a host for today's session and on behalf of the global compliance panel team i'd like to thank you all for being part of today's session today's webinar is being presented by mr. jeff kassov few words about a jeff before we start off today's session mr. Kosloff RAC cqm is also the director of quality at meditators which is a leading manufacturer of endoscopy and colonoscopy devices where he oversees the operation of the quality system and in this position Jeff is responsible for oversight of the document control system and also is the primary liaison with the regulatory affairs officials and also prior to this Jeff's mentor with 13 years at lifecycle cooperated as the director of regulatory affairs where he was responsible for compliance of the corporate quality system and Jeff's received his regulatory affairs cert

FAQs guideline for submitting supporting documentation in drug applications for the manufacture of drug substances

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