Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L....

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?