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1、Quality Assurance and Regulatory Compliance for Pharmaceutical Product,Prof.Dr.Basavaraj K.Nanjwade M.Pharm.,Ph.DDepartment of PharmaceuticsKLE University College of PharmacyBELGAUM-590010,Karnataka,IndiaE-mail:bknanjwadeyahoo.co.inCell No:00919742431000,04th Oct.2011,1,Maharashtra College of Pharma
2、cy,Nilanga,Quality Assurance,Quality assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of a product.It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for thei
3、r intended use.QA is the heart and soul of quality control QA=QC+GMP,04th Oct.2011,2,Maharashtra College of Pharmacy,Nilanga,The System of Quality Assurance,Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as th
4、ose of good laboratory practice(GLP)and good clinical practice(GCP)Product and control operations are clearly specified in a written form and GMP requirements are adopted,04th Oct.2011,3,Maharashtra College of Pharmacy,Nilanga,The System of Quality Assurance,Managerial responsibilities are clearly s
5、pecified in job descriptionArrangements are made for the manufacture,supply and use of the correct starting and packaging materials.All necessary controls on starting materials,intermediate products,and bulk products and other in-process controls,calibrations,and validations are carried out.,04th Oc
6、t.2011,4,Maharashtra College of Pharmacy,Nilanga,The System of Quality Assurance,The finished products is correctly processed and checked according to the defined procedures.Pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has b
7、een produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production,control and release of pharmaceutical products,04th Oct.2011,5,Maharashtra College of Pharmacy,Nilanga,The System of Quality Assurance,Satisfactory arra
8、ngements exist to ensure,as far as possible,that the pharmaceutical products are stored by the manufacturer,distributed and subsequently handled so that quality is maintained throughout their shelf-life.There is a procedure for self-inspection and/or quality audit that regularly appraises the effect
9、iveness and applicability of the quality assurance system,04th Oct.2011,6,Maharashtra College of Pharmacy,Nilanga,The System of Quality Assurance,Deviation are reported,investigated and recordedThere is a system for approving changes that may have an impact on product qualityRegular evaluations of t
10、he quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.,04th Oct.2011,7,Maharashtra College of Pharmacy,Nilanga,QC,GMP,QA,Quality relationships,04th Oct.2011,8,Maharashtra College of Pharmacy,Ni
11、langa,Quality Assurance,It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use,04th Oct.2011,9,Maharashtra College of Pharmacy,Nilanga,Good Manufacturing Practice,Is that part of Quality Assurance aimed at
12、 ensuring that products are consistently manufactured to a quality appropriate to their intended use,04th Oct.2011,10,Maharashtra College of Pharmacy,Nilanga,Good Manufacturing Practice,Raw or starting materials Finished products Premises and environment EquipmentpersonnelTraining Hygiene,04th Oct.2
13、011,Maharashtra College of Pharmacy,Nilanga,11,GMP Covers all aspects of production including,GOOD MANUFACTURING PRACTICE,04th Oct.2011,12,Maharashtra College of Pharmacy,Nilanga,Quality Control,Is that part of GMP concerned with sampling,specification&testing,documentation&release procedures which
14、ensure that the necessary&relevant tests are performed&the product is released for use only after ascertaining its quality,04th Oct.2011,13,Maharashtra College of Pharmacy,Nilanga,QA and QC,QC is that part of GMP which is concerned with sampling,specifications,testing and with in the organization,do
15、cumentation,and release procedures which ensure that the necessary and relevant tests are carried out,QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use.,04th Oct.2011,14,Maharashtra College of Pharmacy,Ni
16、langa,QA and QC,Operational laboratory techniques and activities used to fulfill the requirement of Quality,All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality,04th Oct.2011,15,Maharashtra College of Pharmacy,Nilan
17、ga,QA and QC,QC is lab based,QA is company based,04th Oct.2011,16,Maharashtra College of Pharmacy,Nilanga,04th Oct.2011,17,Maharashtra College of Pharmacy,Nilanga,04th Oct.2011,18,Maharashtra College of Pharmacy,Nilanga,Quality Assurance-Highlights,In process quality checking in manufacturingValidat
18、ion of facilities,equipments,process,products and cleaning Complaint handlingStorage of quality records and control samplesStability studies,04th Oct.2011,19,Maharashtra College of Pharmacy,Nilanga,Quality Assurance Activities,Technology TransferValidationDocumentation ControlAssuring Quality of Pro
19、ductsQuality Improvement Plans,04th Oct.2011,20,Maharashtra College of Pharmacy,Nilanga,1.Technology Transfer,Receipt of product design documents from R&D DepartmentDistribution of documents to different departmentsChecking and approval of documents generated based on R&D documents i.e.batch manufac
20、turing recordScaleup and validation of product,04th Oct.2011,21,Maharashtra College of Pharmacy,Nilanga,2.Validation,Preparation of validation plans for facility,equipments/process including cleaningApproval of protocol for validation of facility/equipment/product/process Team member for execution o
21、f validation of facility/equipment/product/process,04th Oct.2011,22,Maharashtra College of Pharmacy,Nilanga,3.Documentation Control,Controlled distribution and archiving of documentsControl of changes made by proper change control procedure Approval of all documents,04th Oct.2011,23,Maharashtra Coll
22、ege of Pharmacy,Nilanga,4.Assuring Quality of Products,cGMP trainingSOP complianceAudit of facility for complianceLine clearanceInprocess counter checksCritical samplingRecord verificationRelease of batch for marketingInvestigation of market complaints,04th Oct.2011,24,Maharashtra College of Pharmac
23、y,Nilanga,5.Quality Improvement Plans,To take Feedback from different departmentsProposals for corrective and preventive actionsAnnual Products reviewTrend analysis of various quality parameters for products,environment and water,04th Oct.2011,25,Maharashtra College of Pharmacy,Nilanga,FACTORS IN DR
24、UG QUALITY ASSURANCE,DRUGPRODUCTQUALITY,Labeling&ProductInformation,Import&ExportControl,Raw Materials-Active&Inactive,ManufacturingProcesses&Procedures,Storage,TransportDistributionDispensing&Use,QC&Analysis,HumanResources-Professionals,Legislative Framework-Regulations,Packaging,04th Oct.2011,26,M
25、aharashtra College of Pharmacy,Nilanga,04th Oct.2011,27,Maharashtra College of Pharmacy,Nilanga,In process quality checking in manufacturing Validation of facilities,equipments,process,products and cleaning Complaint handling Storage of quality records and control samples Stability studies,Quality A
26、ssurance,Highlights,04th Oct.2011,28,Maharashtra College of Pharmacy,Nilanga,04th Oct.2011,29,Maharashtra College of Pharmacy,Nilanga,Equipment/Instrument Qualification,Before a process can be validated the equipment,facilities&services used in that process must themselves be validated such an opera
27、tion is referred to as qualificationQualification therefore,an integral part of process validation which in turn is part of GMP,04th Oct.2011,30,Maharashtra College of Pharmacy,Nilanga,Equipment/Instrument Qualification,04th Oct.2011,31,Maharashtra College of Pharmacy,Nilanga,Equipment/Instrument Qu
28、alification,04th Oct.2011,32,Maharashtra College of Pharmacy,Nilanga,Why to qualify,If the instrument is not qualified prior to use&if a problem occurs,the source of problem will be difficult to identify.,04th Oct.2011,33,Maharashtra College of Pharmacy,Nilanga,Qualification Involves,04th Oct.2011,3
29、4,Maharashtra College of Pharmacy,Nilanga,Details Record in Change Control,Request for changeChange control No.DateChange related to product/document/system/facilityConcerned documents with numberDescription of changeReason for changeImpact of change,04th Oct.2011,35,Maharashtra College of Pharmacy,
30、Nilanga,Details Record in Change Control,Proposed methodology for implementationCategory of changeType of changeComparison criteria for evaluation of the changeAssessment of impact of changeApproval of changeImplementation of changeClosure of change,04th Oct.2011,36,Maharashtra College of Pharmacy,N
31、ilanga,Details Recorded in Deviation Approval,Deviation no.Deviation related toConcerned identity number(Batch No.,Code No.etc)Type of deviation(Planed/Unplaned)Description of deviationReason/Investigation with documentCategory of deviationRoot cause analysis,04th Oct.2011,37,Maharashtra College of
32、Pharmacy,Nilanga,Details Recorded in Deviation Approval,Impact of deviation(on batches,Products,Items,etc)Immediate actionCAPA(Corrective and Preventive Action)Impact of CAPAIntimation to concernedComments from concernedPeriodic reviewFinal reviewDeviation close-outEvaluation of implemented CAPA,04t
33、h Oct.2011,38,Maharashtra College of Pharmacy,Nilanga,Details Recorded In Out of Specification Report,OOS No.(Out of Specification)Reporting of OOSInformation of OOS to immediate seniorAssessment of analytical data by immediate seniorDiscussion between analyst and immediate seniorSampling and analys
34、isData compilationAssignable cause identificationFull scale OOS investigation(Cause not identified)EvaluationConclusionCAPAOOS results summary,04th Oct.2011,39,Maharashtra College of Pharmacy,Nilanga,Area of Self Inspection,Personal&Personal detailsPremises including personnel facilitiesMaintenance
35、of building&equipmentStorage of starting material&finished products(Stores)EquipmentProduction&In-process controlsCephalosporin Mfg&PackingManufacturingPackingQuality controlDocumentationSanitation&HygieneValidation and revalidation program,04th Oct.2011,40,Maharashtra College of Pharmacy,Nilanga,Ar
36、eas of Self Inspection,Calibration of instruments or measurement systemRecall procedureComplaints managementLabels controlComputerized systemEngineeringDocuments related to regulatory affairsDiscarding of residuesQuality assuranceControl on contract analysisResults of previous self inspection,qualit
37、y audit and any corrective steps taken,04th Oct.2011,41,Maharashtra College of Pharmacy,Nilanga,Details Recorded in Complaint Investigation Report,Complaint No.Product NameManufacturing and Expiry of productSource of complaintDate of receipt of complaintNature of complaintCategory of complaint,04th
38、Oct.2011,42,Maharashtra College of Pharmacy,Nilanga,Details Recorded in Complaint Investigation Report,InvestigationImpact of complaint on other batches/productsBatches/ProductsReviewCAPAImpact of CAPAImplementation of Preventive actionClose out of complaint,04th Oct.2011,43,Maharashtra College of P
39、harmacy,Nilanga,Acceptance Criteria,04th Oct.2011,44,Maharashtra College of Pharmacy,Nilanga,RPN:Risk Priority Number,04th Oct.2011,45,Maharashtra College of Pharmacy,Nilanga,ROOT CAUSE ANALYSIS,04th Oct.2011,46,Maharashtra College of Pharmacy,Nilanga,Regulatory ComplianceFor Pharmaceutical Product,
40、04th Oct.2011,47,Maharashtra College of Pharmacy,Nilanga,Regulatory Requirements,Regulatory requirements are part of the process of drug discovery and drug development.Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country.In the US,i
41、t is the function of the Food and Drug Administration(FDA)to establish these regulatory requirements.The European Medicines Agency(EMA)and Japanese Pharmaceuticals and Medical Devices Agency(PMDA)are also important regulatory authorities in drug development.These three agencies oversee the three lar
42、gest markets for drug sales,04th Oct.2011,48,Maharashtra College of Pharmacy,Nilanga,Regulatory Compliance,In general,compliance means conforming to a rule,such as a specification,policy,standard or law.Regulatory compliance describes the goal that corporations or public agencies aspire to in their
43、efforts to ensure that personnel are aware of and take steps to comply with relevant laws and regulations.,04th Oct.2011,49,Maharashtra College of Pharmacy,Nilanga,Pharmaceutical Product Quality Cannot Be Tested in-It Is Built in,Pharmaceutical product quality is assured by Comprehensive development
44、 programExtensive manufacturing and environmental controls Rigorous validation procedures and requirementsCompliance to regulatory requirementsThe high quality thus built into the final product is ensured through in-process controls and verified in a series of confirmatory tests before each manufact
45、ured batch is released to the market,04th Oct.2011,50,Maharashtra College of Pharmacy,Nilanga,Quality=Quality of Manpower(Qualification,Training)+Quality of Materials(Specifications,Approved Suppliers.)+Quality of Means(Qualified equipments,maintenance)+Quality of Media(GMP premises,Controlled envir
46、onment)+Quality of Methods(Calibration,Validation),Composition of Quality,04th Oct.2011,51,Maharashtra College of Pharmacy,Nilanga,Functions of a Quality Unit,Quality ControlSampling and testing of components(raw materials,Packing materials),intermediates and finished products Compliance to Good Lab
47、oratory Practices(GLPs),04th Oct.2011,52,Maharashtra College of Pharmacy,Nilanga,Functions of a Quality Unit,Quality AssuranceDesigning robust quality systemsEnsure compliance to relevant regulatory requirementsEnsure compliance to requirements of Good Manufacturing Practices(GMP),04th Oct.2011,53,M
48、aharashtra College of Pharmacy,Nilanga,Value addition in QA function,Quality Assurance:Perform structured self-inspection audits at regular intervals to prevent any failure or non-conformance Critically analyze the quality non-conformance issues and suggest corrective and preventive actions,04th Oct
49、.2011,54,Maharashtra College of Pharmacy,Nilanga,Value addition in QA function,Quality Assurance:Perform documentation audit to ensure realistic recording of all the relevant process parametersReview the adequacy of in-process control checks to prevent any potential failures,04th Oct.2011,55,Maharas
50、htra College of Pharmacy,Nilanga,Value addition in QA function,Quality Assurance:Training&Knowledge ManagementPerform literature survey of FDA/ICH/ISO guidelines,revisions in the Pharmacopoeial specifications and the current regulatory requirements and provide training to the production personnel.,0
