Copenhagen workshop may 2014
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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.

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Copenhagen Workshop May 2014

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Copenhagen workshop may 2014

Copenhagen Workshop May 2014

Session outlines

and objectives

L. Paleshnuik

Lead Quality Assessor

PQT

  • 1


Schedule of talks

Day 1

• Prequalification: Overview and update

• Bioequivalence

• WHOPARs and labeling

• Quality assessment principles: Part I

• API assessment: impurities

• Specifications

Schedule of talks

2


Schedule of talks1

Day 2

• Packaging

• Quality assessment principles: Part II

• Pharmaceutical development

• Process validation

• Stability assessment: API and FPP

• Collaborative procedure

Schedule of talks

3


Schedule of talks2

Day 3

• Assessing batch records

• GMP issues in quality assessment

Schedule of talks

4


Your part icipation

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

Your participation

5


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

Questions

6


Your part icipation1

Day 3

• Fill out the workshop evaluation

(Very important)

• One-on-one breakout sessions (feedback and guidance)

Your participation

7


Your part icipation2

Day 4

• Written exam

• Workshop wrap-up and final close

Your participation

8


Copenhagen workshop may 2014

Common technical document

CTD

9


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

Acronyms!

10


Acronyms1

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

Acronyms!

11


Acronyms2

SST - system suitability testing

TRS – WHO technical report series publication

WHOPAR – WHO public assessment report

Acronyms!

12


Questions1

Questions?

Questions?

  • 56


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