lynda paleshnuik | january 2011 1 |1 | quality workshop copenhagen – january 2011 training session...
TRANSCRIPT
Lynda Paleshnuik | January 20111 |
Quality WorkshopCopenhagen – January 2011
Quality WorkshopCopenhagen – January 2011
Training session
Outline
and Objectives
Lynda Paleshnuik | January 20112 |
Outline – Day 1Outline – Day 1
General talks:
Prequalification of Medicines Programme (PQP)
The new WHO/PQP quality guidelines
The new WHO/PQP quality templates
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Outline – Day 1 continuedOutline – 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
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Outline – Day 2Outline – 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
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Outline – Day 3Outline – Day 3
Final general and FPP talks:
GMP lessons for quality review
Assessing production documents: executed and master records
Breakout sessions begin.
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ObjectivesObjectives
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ObjectivesObjectives
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.
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ObjectivesObjectives
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.
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Quality AssessmentQuality 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
Lynda Paleshnuik | January 201110 |
Quality AssessmentQuality 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.
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Quality AssessmentQuality Assessment
“… is a primeval jungle, an amazing thicket, without escape or end, into which one would not dare to enter”
Friedrich Wöhler
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Quality assessment – brute forceQuality assessment – brute force
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Quality Assessment – assessing smartQuality Assessment – assessing smart
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Assessing smartAssessing 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
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Questions?