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Copenhagen Workshop May 2014

Session outlines and objectives

L. PaleshnuikLead Quality Assessor

PQT

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Schedule of talks

Day 1• Prequalification: Overview and update • Bioequivalence• WHOPARs and labeling • Quality assessment principles: Part I • API assessment: impurities• Specifications

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Schedule of talks

Day 2• Packaging• Quality assessment principles: Part II • Pharmaceutical development• Process validation • Stability assessment: API and FPP• Collaborative procedure

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Schedule of talks

Day 3• Assessing batch records • GMP issues in quality assessment

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Your participation

Days 1 and 2• Open discussion/Q&A on the day’s topics • Participate in the exercises/discussions • Ask questions during/after talks or at the end of the day, • Collect questions for your one-on-one session

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Questions

Questions are good• The speaker will say if questions should be held for the end of their talk • Please speak slowly when posing Qs• Questions can be given to any of the facilitators, to be handled at end of day• A speaker may defer a complex question

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Your participation

Day 3• Fill out the workshop evaluation(Very important)• One-on-one breakout sessions (feedback and guidance)

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Your participation

Day 4• Written exam• Workshop wrap-up and final close

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CTD

Common technical document

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Acronyms!

API – active pharmaceutical ingredientBCS – biopharmaceutics classification systemCOA - certificate of analysisCTD – common technical documentEC – enteric coatedER – extended releaseFDC – fixed dose combinationFPP – finished pharmaceutical productGC – gas chromatography

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Acronyms!

ICH – international conference on harmonizationNMRA – national medicines regulatory authorityPhInt – International PharmacopoeiaPQ/PQT – Prequalification of Medicines TeamPSD – particle size distributionQA – quality assuranceQRM – quality risk managementSPC/SmPC – summary of product characteristics

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Acronyms!

SST - system suitability testingTRS – WHO technical report series publicationWHOPAR – WHO public assessment report

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Questions?

Questions?