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Lynda Paleshnuik | May 20141
Copenhagen Workshop May 2014
Session outlines
and objectives
L. Paleshnuik
Lead 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 ingredient
BCS – biopharmaceutics classification system
COA - certificate of analysis
CTD – common technical document
EC – enteric coated
ER – extended release
FDC – fixed dose combination
FPP – finished pharmaceutical product
GC – gas chromatography
Lynda Paleshnuik | May 201411
Acronyms!
ICH – international conference on harmonization
NMRA – national medicines regulatory authority
PhInt – International Pharmacopoeia
PQ/PQT – Prequalification of Medicines Team
PSD – particle size distribution
QA – quality assurance
QRM – quality risk management
SPC/SmPC – summary of product characteristics
Lynda Paleshnuik | May 201412
Acronyms!
SST - system suitability testing
TRS – WHO technical report series publication
WHOPAR – WHO public assessment report
Lynda Paleshnuik | May 201456
Questions?
Questions?