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:: Good Manufacturing Practices Pdf Free Download ::

 
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MessagePosté le: Ven 2 Sep - 05:17 (2016)    Sujet du message: Good Manufacturing Practices Pdf Free Download Répondre en citant




Good Manufacturing Practices Pdf Free Download > urlin.us/3ypqo























































Good Manufacturing Practices Pdf Free Download

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43.,,Sterile,,,,(strile):,,,,Free,,,,from,,,,viable,,,,microorganisms.,,,,Electronic,,,data,,,must,,,be,,,readily,,,retrievable,,,in,,,a,,,printed,,,format.,,,On,,,,line,,,,verification,,,,of,,,,all,,,,labels,,,,by,,,,automated,,,,electronic,,,,means,,,,can,,,,be,,,,helpful,,,,in,,,,preventing,,,,mix-ups.,,,,The,,,,following,,,,text,,,,should,,,,be,,,,used:,,,,"I,,,,hereby,,,,certify,,,,that,,,,the,,,,above,,,,information,,,,is,,,,authentic,,,,and,,,,accurate.,,,,

Regulation,,,C.02.017,,,(1),,,The,,,examination,,,or,,,testing,,,referred,,,to,,,in,,,section,,,C.02.016,,,shall,,,be,,,performed,,,on,,,a,,,sample,,,taken,,,(a),,,after,,,receipt,,,of,,,each,,,lot,,,or,,,batch,,,of,,,packaging,,,material,,,on,,,the,,,premises,,,of,,,the,,,person,,,who,,,packages,,,a,,,drug;,,,or,,,(b),,,subject,,,to,,,subsection,,,(2),,,,before,,,receipt,,,of,,,each,,,lot,,,or,,,batch,,,of,,,packaging,,,material,,,on,,,the,,,premises,,,of,,,the,,,person,,,who,,,packages,,,a,,,drug,,,,if,,,(i),,,that,,,person,,,(A),,,has,,,evidence,,,satisfactory,,,to,,,the,,,Director,,,to,,,demonstrate,,,that,,,packaging,,,materials,,,sold,,,to,,,him,,,by,,,the,,,vendor,,,of,,,that,,,lot,,,or,,,batch,,,of,,,packaging,,,material,,,are,,,consistently,,,manufactured,,,in,,,accordance,,,with,,,and,,,consistently,,,comply,,,with,,,the,,,specifications,,,for,,,those,,,packaging,,,materials;,,,and,,,(B),,,undertakes,,,periodic,,,complete,,,confirmatory,,,examination,,,or,,,testing,,,with,,,a,,,frequency,,,satisfactory,,,to,,,the,,,Director,,,,(ii),,,the,,,packaging,,,material,,,has,,,not,,,been,,,transported,,,or,,,stored,,,under,,,conditions,,,that,,,may,,,affect,,,its,,,compliance,,,with,,,the,,,specifications,,,for,,,that,,,packaging,,,material.,,,7.9.1,,,,Procedures,,,,are,,,,in,,,,place,,,,to,,,,describe,,,,the,,,,steps,,,,to,,,,be,,,,taken,,,,as,,,,part,,,,of,,,,the,,,,investigation.,,,,Identity,,is,,confirmed,,by,,the,,packager/labeller,,after,,the,,lot,,or,,batch,,is,,packaged.,,1.4,,Retention,,samples,,may,,be,,stored,,at,,another,,Canadian,,site,,pursuant,,to,,a,,written,,agreement,,clearly,,describing,,the,,respective,,responsibilities,,of,,each,,party.,,The,,adequacy,,of,,test,,or,,examination,,methods,,that,,are,,not,,of,,pharmacopeial,,or,,equivalent,,status,,is,,established,,and,,documented.,,7.,,Areas,,where,,biological,,,microbiological,,or,,radioisotope,,testing,,is,,carried,,out,,require,,special,,design,,and,,containment,,considerations.,,During,,the,,retention,,period,,,such,,records,,must,,be,,secured,,and,,accessible,,within,,48,,hours,,to,,the,,fabricator,,,packager/labeller,,,distributor,,,or,,importer.,,The,,,agreement,,,specifies,,,their,,,respective,,,responsibilities,,,relating,,,to,,,the,,,fabrication,,,or,,,packaging/labelling,,,and,,,control,,,of,,,the,,,product.,,,

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