Transcript Training session outline and objectives

Quality Workshop
Copenhagen – January 2011
Training
session
Outline
and
Objectives
1|
Lynda Paleshnuik | January 2011
Outline – Day 1
General talks:
Prequalification of Medicines Programme (PQP)
The new WHO/PQP quality guidelines
The new WHO/PQP quality templates
2|
Lynda Paleshnuik | January 2011
Outline – Day 1 continued
Active Pharmaceutical Ingredient (API) talks:
API assessment: Approaches and considerations
Impurities: Establishing specifications (API and FPP)
Finished Pharmaceutical Product (FPP) talks begin:
Pharmaceutical development: ICH Q8 “minimal”
approach
3|
Lynda Paleshnuik | January 2011
Outline – Day 2
FPP talks continue:
Dissolution case studies
Supporting documents for assessment – SUPAC
FPP assessment: Approaches and considerations
Method and validation basics – HPLC case study
Formulation development issues for solid orals
Stability
4|
Lynda Paleshnuik | January 2011
Outline – Day 3
Final general and FPP talks:
GMP lessons for quality review
Assessing production documents: executed and master
records
Breakout sessions begin.
5|
Lynda Paleshnuik | January 2011
Objectives
6|
Lynda Paleshnuik | January 2011
Objectives
General objectives
Increase knowledge of key quality areas: impurities, methods
and their validation, dissolution, pharmaceutical development
and stability.
One-on-one feedback: provides a forum for individual
questions to be answered by a senior assessor.
Make note of any and all questions re PQP and quality
assessment as they occur to you.
7|
Lynda Paleshnuik | January 2011
Objectives
Providing insight into some commonly encountered
deficiencies and how to deal with them.
Specific objectives
Introduction to the new quality guidelines and templates, and
how these are being implemented in PQP.
8|
Lynda Paleshnuik | January 2011
Quality Assessment
Manufacturing sciences
Pharmaceutical engineering/pharmaceutical technology
(production methods and systems, facilities, equipment, etc.)
Pharmaceutical sciences
Chemistry (organic, inorganic, physical, biochemical, analytical
(e.g. methodology, validation, spectral analysis))
Pharmaceutical chemistry (study of drug design)
Pharmaceutics (study of drug formulation)
Pharmacognosy (study of drugs of natural origin)
Other fields: Math/statistics, microbiology, GMP
9|
Lynda Paleshnuik | January 2011
Quality Assessment
Quality assessment:
Covers many fields of knowledge
Complex (issues have multiple factors involved)
Involves large amounts of data
No two products are the same
First assessment (and report!) of the original dossier is the
most important part of the process.
10 |
Lynda Paleshnuik | January 2011
Quality Assessment
“… is a primeval jungle, an amazing thicket, without escape or
end, into which one would not dare to enter”
Friedrich Wöhler
11 |
Lynda Paleshnuik | January 2011
Quality assessment – brute force
12 |
Lynda Paleshnuik | January 2011
Quality Assessment – assessing smart
13 |
Lynda Paleshnuik | January 2011
Assessing smart
 Critical thinking – how deeply to assess given data
► how important is this
► how does it relate to other data
► “less important” areas can be skimmed through BUT
it is important to watch for red flags that require a closer
look
 Continually learning
 Staying on top of guidelines and advances – e.g. Q&A docs
14 |
Lynda Paleshnuik | January 2011
Questions?
15 |
Lynda Paleshnuik | January 2011