3 Quality is never an accident; it is always the result of high intention,sincere effort, intelligent direction and skillfulexecution;it represents the wise choice of many alternatives.~ William A. Foster ~
4 Basis for Quality Requirements Customer expectationsGood Business PracticeGood Science PracticeRegulatory conformance
5 Regulatory Agencies FDA (Food and Drug Administration) To promote/protect public health by helpingsafe/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 medicinesOther National Agencies (MHRA, IMB, ANVISA, etc.)To ensure medicines sold/supplied to other countriesare safe, efficacious and meet required quality.
6 Requirements within the Code of Federal Regulations 21CFR 211 Requirements within the Code of Federal Regulations 21CFR for the Quality UnitAccording to US regulations,the Quality Unitmust act independentlyof production/manufacturingin executing it’s responsibilities.TRANSITION: Let’s take a look at some of the key responsibilities of the Quality unit.Role of GQO
7 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
8 Typical Quality Unit Quality Control + Quality Assurance __________________Quality Unit
9 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 moreTRANSITION: One of GQOs key responsibilities is ensuring systems/programs. We do that thru the 27 Quality System Elements. SHOW: Slide #8 and briefly explain.Role of GQO
10 Quality is maintained throughout the product life cycle… <<<<<<<Quality Assurance + Quality Control >>>>>>>>
11 Key Quality Processes Quality Control Product Disposition Marketed Product Support
12 Quality Control Sampling and Testing Raw MaterialsMediaComponentsProcess materialsWaterEnvironmentIn-ProcessCell banksBulk drug substanceFinished Product
16 Product Disposition Batch Record Review Test Record Review InvestigationsChange Controls
17 Product Disposition continued Key responsibilities at Product DispositionMarketing authorizationCompliance with cGMP’sUnderstanding impact of deviations --quality, safety, efficacyEngagement in quality systems supportingproduct manufacture and controlUnderstanding those deviationsrequiring regulatory action.TRANSITION: Now let’s take a look at what happens after the product goes to market.
18 Marketed Product Support StabilityCell banksActive SubstanceFinal Drug ProductAnnual Product ReviewsField Alerts & Biological Products Deviation Report(BPDRs)Product QualityInquiriesComplaintsAdverse Events
19 Marketed Product Support continued InquiriesA 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.ComplaintsA report regarding an alleged defect associated with physical, chemical, microbiological, or other aspect of a product, component, or package.
20 Marketed Product Support continued Adverse EventsAny untoward, undesired or unplanned eventin the form of signs, symptoms, disease or laboratoryor physiological observations occurring in a personadministered a product
21 Quality Personnel Competencies Good science practicesProblem solvingGood analytical practicesGood documentation practicesEffective communication skillsVerbal and writtenDecision makingPursuit of “WHY?”