biopharmaceutical quality cynthia h sarnoski phd 28 th june 2012
TRANSCRIPT
Biopharmaceutical Quality
Cynthia H Sarnoski PhD28th June 2012
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What is Quality?
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Quality
Quality is never an accident;
it is always the result of high intention,
sincere effort, intelligent direction and skillful
execution;it represents the wise choice of many alternatives.
~ William A. Foster ~
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Basis for Quality Requirements
Customer expectationsGood Business PracticeGood Science PracticeRegulatory conformance
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Regulatory Agencies
FDA (Food and Drug Administration)To promote/protect public health by helping safe/effective products reach the market in a timely way.
EMEA (European Agency for the Evaluation of Medicinal Products)To protect public health thru evaluation and supervision of
medicines
Other National Agencies (MHRA, IMB, ANVISA, etc.)
To ensure medicines sold/supplied to other countries are safe, efficacious and meet required quality.
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Requirements within the Code of Federal Regulations 21CFR 211.22 for the Quality Unit
Role of GQO
According to US regulations,
the Quality Unit
must act independently
of production/manufacturing
in executing it’s responsibilities.
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Current Good Manufacturing Practices 21CFR 211
Establish requirements for the manufacture of safe, effective, potent, pure and stable products.These include:Facilities, Equipment, Process, and Materials are appropriate for intended purpose.Appropriately skilled personnelManagement ControlsDocumented evidence
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Typical Quality Unit
Quality Control +Quality Assurance__________________Quality Unit
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Quality Unit Responsibilities
Approve or reject all Production MaterialsReview and approve allProcedures and SpecificationsValidation/Qualification documentsChange ControlsRegulatory SubmissionsEnsure systems/programs are established and maintained for:Adequate inspection, sampling, and testingIdentification of deviations, investigations and corrective actions/preventative actionsMany, many more . . . . .
Role of GQO
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Quality is maintained throughout the product life cycle…
Cell BanksRaw
MaterialsComponents
Cell Culture PurificationActive
SubstanceFinal
Product
<<<<<<<Quality Assurance + Quality Control >>>>>>>>
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Key Quality Processes
Quality Control
Product Disposition
Marketed Product Support
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Quality Control Sampling and Testing
● Raw Materials● Media● Components● Process materials● Water● Environment● In-Process● Cell banks● Bulk drug substance● Finished Product
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Laboratory Controls
Sample chain of custodyCompendial standardsValidated methodsReagent controlReference standardsEquipment ValidationEquipment CalibrationDocumentation
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Testing Requirements
Adventitious agent contamination controlViral, microbialPotencyPurityProcessStabilityCharacterizationIdentitySafetyComposition: excipientsForensics
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Drug Product Testing
E n v iro n m e n ta lM o n ito ring
E xc ip ie n ts
E n v irn m en ta lM o n ito ring
R a wM a te ria ls
E n v irn m en ta lM o n ito ring
R a wM a te ria ls
M e d iaC o m p o ne n ts
E n v iro n m e n ta lM o n io to ring
M e d iaC o m p o ne n ts
E n v iro n m e n ta lM o n io to ring
M e d iaC o m p o ne n ts
C e llB a nk
In p roce ssT e s ts
P ro du c tionC e lls
In P roce ssT e s ts
P ro ce ssM a te ria ls
F e rm e n ta tionIn te rm ed ia te
In P roce ssT e s ts
P ro ce ssM a te ria ls
P u rif ica tionIn te rm ed ia te
In P roce ssT e s ts
R e s in s P ro ce ssM a te ria ls
A c tiveS u bs tan ce
C o n ta in erC lo su res
In P roce ssT e s ts
D ru g P ro d u ct
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Product Disposition
Batch Record ReviewTest Record ReviewInvestigationsChange Controls
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Product Disposition continued
Key responsibilities at Product DispositionMarketing authorizationCompliance with cGMP’sUnderstanding impact of deviations --
quality, safety, efficacy
Engagement in quality systems supportingproduct manufacture and control
Understanding those deviations requiring regulatory action
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Marketed Product Support
● Stability●Cell banks●Active Substance●Final Drug Product●Annual Product ReviewsField Alerts & Biological Products Deviation Report (BPDRs) Product QualityInquiriesComplaintsAdverse Events
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Marketed Product Support continued
Inquiries A non-medical comment, question or request for
information such as product availability, temperature/stability, product expiry dating, dosing, product formulations/ingredients, chemical composition of componentry, etc.
Complaints A report regarding an alleged defect associated
with physical, chemical, microbiological, or other aspect of a product, component, or package.
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Marketed Product Support continued
Adverse Events
Any untoward, undesired or unplanned eventin the form of signs, symptoms, disease or
laboratoryor physiological observations occurring in a
personadministered a product
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Quality Personnel Competencies
Good science practicesProblem solvingGood analytical practicesGood documentation practicesEffective communication skillsVerbal and writtenDecision makingPursuit of “WHY?”
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Questions?