Pharmaceutical Quality by Design (QbD)

Quality must be built into the product, it cannot be inspected into it. The Pharmaceutical industries are experiencing a “knowledge and experience deficit” regarding the use of QbD concepts.

1. TRAINER: MD. ZAKARIA FARUKI
Orion PharmaLimited
Dhaka, Bangladesh
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TRAINING ON
Pharmaceutical Quality
by Design (QbD)
ORION

2. Introduction to QbDApproach
QualitybyDesign(QbD)isaQualitySystemfor
managingaproduct’slifecyclewhichisemerging
toenhancetheassuranceofsafe&effectivedrug
supplytotheconsumer,andalsoofferspromise
tosignificantlyimprovemanufacturingquality
performance.
TheQualityofthepharmaceuticalproductcanbe
evaluatedbyinvivoorinvitroperformancetests.
Qualitybydesignassuresinvitroproduct
performanceandInvitroproductperformance
providesassuranceofinvivoproduct
performance.“HenceQualitybydesignrelateto
ProductPerformance”
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3. QbDHistory & Recommendation
Quality by design (QbD) is a concept first developed by the
quality pioneer Dr. Joseph M. Juran
Dr. Juranbelieved that quality should be designed into a
product, and that most quality crises and problems relate to
the way in which a product was designed in the first place.
Woodcockdefined a high-quality drug product as a product
free of contamination and reliably delivering the therapeutic
benefitpromised in the label to the consumer.
The US Food and Drug Administration (FDA) encourages
risk-based approaches and the adoption of QbDprinciples in
drug product development, manufacturing, and regulation.
FDA’s emphasis on QbDbegan with the recognition that
increased testing does not necessarily improve product
quality. Quality must be built into the product.
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4. Definitions
Quality:
Thesuitabilityofeitheradrugsubstanceora
drugproductforitsintendeduse.Thisterm
includessuchattributesastheidentity,strength,
andpurity(ICHQ6A).Pharmaceuticalquality
referstoproductfreeofcontaminationand
reproduciblydeliversthetherapeuticbenefit
promisedinthelabeltotheconsumer.
Quality by Design (QbD):
Asystematicapproachtodevelopmentthat
beginswithpredefinedobjectivesand
emphasizesproductandprocessunderstanding
andprocesscontrol,basedonsoundscience
andqualityriskmanagement.
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5. Principle QbDConcepts
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Risk and knowledge
based decisions
Systematic
approaches for
process development
Continuous
Improvement
This leads to
capable processes
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6. ORION
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7. ORION
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8. ORION
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9. ORION
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11. ORION
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12. ORION
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13. ORION
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14. ORION
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15. QTPP & CQAs
Quality Target Product Profile (QTPP):A prospective summary
of the quality characteristics of a drug product that ideally will
be achieved to ensure desired quality, taking into account
safety and efficacy of a drug product. By Beginning with the
end in mind, the result of development is a robust formulation
and manufacturing process with an acceptable control strategy
that ensures the performances of the Drug Product.
Critical Quality Attributes (CQAs): A CQA is a physical,
chemical, biological, or microbiological property or
characteristic that should be within an appropriate limit, range,
or distribution to ensure the desired product quality. CQAs are
generally associated with the drug substance, excipients,
intermediates (in-process materials), and drug product.
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27. Traditional & QbD
Approaches
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28. Quality by End Product Testing ORION
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29. Quality by Design QbD
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32. What are the Barriers to QbD?
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33. IndustryPerspective &
Implementation of QbD
Fromthepharmaceuticalindustry’sperspective,QbDrequires
developmentofafundamentalscientificunderstandingofcritical
processesandproductattributes,establishmentofdesign
controlsandtestingbasedonproductqualityandwithinthelimits
ofscientificunderstanding,anduseofknowledgegainedovera
product’slifecycletooperateinanenvironmentofcontinuous
improvement.CriticaltoQbDissoundsciencerootedinquality
riskmanagement(QRM).Asstatedpreviously,QbDconceptsare
notnew;rather,“suchinnovationsaretheapplicationofthose
principlesinthedevelopment,submission,andmanufacturingof
drugproductsanddrugsubstances”
Thebiopharmaceuticalindustryiscurrentlyexperiencinga
“knowledgeandexperiencedeficit”regardingtheuseofQbD
concepts.Typically,manufacturerslearnthroughexperience,and
untiltheyhavesuccessfullyusedQbDwithpositiveregulatory
submissions,therewillcontinuetobetrepidationaboutusingthe
QbDframeworkindrugproductdevelopment.
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34. Conclusion
Quality by Design is intended to enhance process knowledge
and is based on existing guidance and reference documents
QbDcan be viewed as a process defined by series of document
requirements as per process knowledge and understanding.
QbDcan be applied to legacy and new products, but the
supporting document package may differ.
The QbDsuite of documents are “alive”. They can and should be
revised as the knowledge base changes.
ThegoalsofimplementingpharmaceuticalQbDaretoreduce
productvariabilityanddefects,therebyenhancingproduct
developmentandmanufacturingefficienciesandpost
approvalchangemanagement.
Finally,QbDischallenge&thecurrentchallengestoQbD
implementationfromanindustryperspectivearenumerous
becauseindustryhasyettofullyembraceitsapplicationto
pharmaceuticalproductdevelopment.
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35. Training on QbDConducted by Md. Zakaria Faruki
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36. Training on QbDConducted by Md. Zakaria Faruki
Intelligent peoples
don't make MISTAKES
However, mistakes make
peoples INTELLIGENT…
ORION
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