View
30
Download
0
Category
Tags:
Preview:
DESCRIPTION
Copenhagen Workshop May 2014. Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQ T. 1. Day 1 • Prequalification: Overview and update • Bioequivalence • WHOPARs and labeling • Quality assessment principles: Part I • API assessment: impurities • Specifications. - PowerPoint PPT Presentation
Citation preview
Lynda Paleshnuik | May 20141
Copenhagen Workshop May 2014
Session outlines and objectives
L. PaleshnuikLead Quality Assessor
PQT
Lynda Paleshnuik | May 20142
Schedule of talks
Day 1• Prequalification: Overview and update • Bioequivalence• WHOPARs and labeling • Quality assessment principles: Part I • API assessment: impurities• Specifications
Lynda Paleshnuik | May 20143
Schedule of talks
Day 2• Packaging• Quality assessment principles: Part II • Pharmaceutical development• Process validation • Stability assessment: API and FPP• Collaborative procedure
Lynda Paleshnuik | May 20144
Schedule of talks
Day 3• Assessing batch records • GMP issues in quality assessment
Lynda Paleshnuik | May 20145
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
Lynda Paleshnuik | May 20146
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
Lynda Paleshnuik | May 20147
Your participation
Day 3• Fill out the workshop evaluation(Very important)• One-on-one breakout sessions (feedback and guidance)
Lynda Paleshnuik | May 20148
Your participation
Day 4• Written exam• Workshop wrap-up and final close
Lynda Paleshnuik | May 20149
CTD
Common technical document
Lynda Paleshnuik | May 201410
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
Lynda Paleshnuik | May 201411
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
Lynda Paleshnuik | May 201412
Acronyms!
SST - system suitability testingTRS – WHO technical report series publicationWHOPAR – WHO public assessment report
Lynda Paleshnuik | May 201456
Questions?
Questions?
Recommended