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dc.contributor.authorAslinger, Josh Michael
dc.date.accessioned2017-03-23T04:30:21Z
dc.date.available2017-03-23T04:30:21Z
dc.date.issued2016-08
dc.identifier.otheraslinger_josh_m_201608_ms
dc.identifier.urihttp://purl.galileo.usg.edu/uga_etd/aslinger_josh_m_201608_ms
dc.identifier.urihttp://hdl.handle.net/10724/36596
dc.description.abstractAtypical Actives play a significant role in the manufacturing of over-the-counter (OTC) and prescription (Rx) drugs. The FDA expects manufacturers of Atypical Actives to follow the ICH Q7 Guidance Document for current Good Manufacturing Practices (cGMPs); however it has been widely reported that not all Atypical Actives are manufactured in accordance with this Guidance. What do Industry Professionals think the level of cGMPs should be to manufacture Atypical Actives? To answer this question, surveys were distributed to manufacturers and industry professionals to determine if higher or lower cGMP standards were required to manufacture “Atypical Actives”. The data set revealed that respondents employed by a member company of IPEC, believe that the cGMP standards for “Atypical Actives” should not be as strict as for “typical” Active Pharmaceutical Ingredients.
dc.languageeng
dc.publisheruga
dc.rightspublic
dc.subjectGood Manufacturing Practices
dc.subjectFood and Drug Administration
dc.subjectAtypical Actives
dc.subjectActive Pharmaceutical Ingredients
dc.subjectConsumer Healthcare Products Association
dc.subjectCHPA
dc.subjectInternational Pharmaceutical Excipients Council
dc.subjectIPEC
dc.titleAdherence of cGMPS for atypical actives for use as active pharmaceutical ingredients
dc.title.alternativesurvey of industry
dc.typeThesis
dc.description.degreeMS
dc.description.departmentPharmaceutical and Biomedical Sciences
dc.description.majorPharmacy
dc.description.advisorDavid Mullis
dc.description.committeeDavid Mullis
dc.description.committeeRon Arkin


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