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39 views1 page

Drydrt

ty

Uploaded by

kapspharmacy
Copyright
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We take content rights seriously. If you suspect this is your content, claim it here.
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ICH Ref No.| Topic & title ‘Subtopic Title / Topie Description ‘OIA [Siailiy Testing of New Drug Substance & Products 1B [Photontabilty Tesiug of New dug Substance & producte w easy OC _|Siabiliy Testing for New Dosage Forms ‘QI [Bracketing & Matrixing Design fr stability testing of New Drag Substance & Products QUE [Evaluation of Stability Data QL __| Stability Dain pockage for Regisvation applications in Climate Zone Ml & IV = Witham (G2__[Analyieal Vaidaion| | Valdation of Anabicl Procedure = Text & Methodoly GBA [impunties in New Drug Substance Q3B [Impurities im New Drug Products co) Impurities | ~O3C | Guideines for Residual Solvents Q3D_| Guidelines for Eemeatal Impurities ‘Q3E__|Assessment& Coutol ofFxtracables & Jenchables for Pharmacutieas & Biologics ‘Q4A_|Pharmacopocial Hormenisation 24 _|_ Pharmacopocias [Qa [Evaluation & recommendation of Panaacopactal ew Tore fx ICH resons ‘Q5A _| Vil Safety Fvalution of Biotechnology Products dereived fiom Cell ines of una or aia ota Quilty of | O38 [Analysis of te expression Coustct in cells used for production of RNA derived protei products 05 | Biotecinologil | —O5C | Quality of Biotechnology Produets - stabil testing of bioteechnolgial/ bilogiea products rodeuts (Q5D_[Desivtion & Chrsctezaiono cll batts used for production of biotechnological products Q5E_ | Compartiliy of biotechnological bologial products subject fo change in mannfactting process o Pea ‘Q6A | Test Procedure & Acceptance Criteria for New Drug Substance & Products: Chemieal Substances ations | Q6B [Test Procedure & Acceptance Criteria for Botechacogical/Bilogieal Prodeuls a GMP = [Good Manufacturing Practise Guide for Active Pharmaceutical lagredients Os PD = _[Pharmscseutial Development co “ORM = [Quality Risk Management Quo POS =| Pharmaceatial Quality System Development & Qt |atanufacture of Drug] - | Development & Manufacture of Drug Substance - (Chemical Entities and Bioteechnoloical/ Biological Substance cites a2 ae «| Fectnicsl& Reyuatory Consideration of Pharmacewseal Product Life Cyole Management Continous 5 as Mate | _-_ [Contin niauticnsing of Dmg Sutnces nd Dr Prodts ais [Ansel Procedure) _ | auatyical Procedure development & Revision of Q2 - Analytical Validation Development

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