total quality management

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  • 1. Total Quality ManagementAn industry perspectivePresented by :: Presented byK.Niranjan Goud K.Niranjan GoudM.Pharmacy (QA)M.Pharmacy (QA)Lovely Professional University, PunjabLovely Professional University, PunjabLPU1

2. Quality is Invisible when GOOD Impossible to ignore when BAD.LPU 2 3. Over viewOrganizationPersonnelResponsibilitiesTrainingHygieneRecordsEquipment -Selection Purchase Specifications,Maintenance, Clean In Place And Sterilize In Placemethods.LPU 3 4. The 5Ms of Quality Man Material Machinery Manuals/Methodology(SOP) MotivationLPU 5. Quality Systems OrganizationCorrective & PreventiveActionsProduction &Design Controls Process Controls Management Material Equipment & ControlsFacility ControlsRecords,Documents, & Change ControlsLPU5 6. Organizations purportObjectives o To prevent risks o To detect deviations o To correct errors o To improve efficiency o To reduce costs How : By establishing a quality manual defining o Organizational structure Staff o Responsibilities o Procedures and processes o Resources o DocumentationLPU 6 7. PersonnelPersonnel Qualifications An adequate number of personnelQualified by appropriate education, trainingExperience to performSupervise the manufacture of intermediates and APIsSpecified in writingTraining should be regularly conducted by qualified individualsParticular operations that the employee performs and GMP as it relates to the employees functions.LPU7 8. Personnel Hygiene Personnel should practice good sanitation and health habits. Wear clean clothing suitable for the manufacturing activity withwhich they are involved Clothing should be changed, when appropriate Necessary wearings Avoid direct contact with intermediates or APIs. Restricted to certain designated areasLPU8 9. .....Personnel Minimum number of personnel in clean areaso Especially during aseptic processing Inspections and controls from outside Training to all including cleaning and maintenance staffo Initial and regularo Manufacturing, hygiene, microbiology Special caseso Supervision in case of outside staffo Decontamination procedures (e.g. staff who worked with animal tissuematerials)8.4 8.6LPU9 10. .....Personnel High standards of hygiene and cleanliness Periodic health checks No shedding of particles No introduction of microbiological hazards No outdoor clothing Changing and washing procedure No watches, jewellery and cosmetics 8.4 8.6LPU10 11. Training.. Design and deliver GMP related trainings Training assessment design Recording of assessment Preparation of training reports. To write training materials Identification of training requirements Available resources Preparation of training aid checklists for staffs.LPU11 12. How does good equipment managementaffect Quality assurance Ensures reliable test results and customer satisfaction thuscredibility of the lab Reduces interruption of services and delays in reportingdue to breakdownsLPU12 13. Equipment CriteriaSelectionPurchase / AcquisitionInstallationCalibration /ValidationMaintenance - Service and repairReplacementLPU 13 14. ..Selection Criteria Use - Matching equipment with servicePerformance characteristics and safety Facility requirements - - Availability of space, accessibility Cost Supply of reagents Ease of operation Warranty Availability of manufacturer technical support Service ContractsLPU14 15. Economics of maintenanceMaintenance is a costly activity. - How much maintenance is needed? - Extent of the maintenance facilities and strength ofmaintenance squad. - When and how often ?? - Is centralized maintenance desirable? or - Should maintenance be done only by out side contractors.LPU 15 16. Preventive Maintenance Optionso In house service of small equipment, e.g., microscopes, washers, pipetteso Team of biomedical service technicians or AMC by manufacturer Regular schedule is usually provided by the firm. Ensure strict compliance of the schedule. Ensure all jobs have been performed as per checklist. Verify the quality of job performed by the firm.LPU 16 17. Equipment Maintenance: Documents and records Equipment History card :A record for equipment inventory Name, Model #, Serial # Location in lab Date purchased Manufacturer and vendor contact information Warranty, expiration date Spare partsFor each piece of equipment: Establish routine maintenance plan Establish required function checks Develop a list of spare partsLPU 17 18. Equipment Sterilization Sterilizers should be designed with a door at each end Effective sterilization of equipment Maintenance and repairs from outside the clean areao If taken apart, resterilized before useo Use clean instruments and tools Planned maintenance, validation and monitoringo Equipment, air filtration systems, sterilizers, water treatment systems 10.1 10.5LPU18 19. Documentation and Records Is an essential part of the Quality assurance Specifications for all materials, Method of manufacture and control To provide an audit trail Permits investigation of the history of any suspected defective batch. Electronic data processing methods Authorized persons shall enter modify dataLPU19 20. Documents designed, prepared, reviewed Documents shall be approved, signed and dated byappropriate and authorized persons. Documents shall specify the title, nature and purpose. They shall be laid out in an orderly fashion and be easy tocheck. Reproduced documents shall be clear and legible. Documents shall be regularly reviewed and kept up to date. Any alteration made in the entry of a document shall besigned and dated.LPU 20 21. The records shall be made or completed at the time of eachoperationRecords and associated Standard Operating Procedures (SOP) shallbe retained for at least one year after the expiry date of the finishedproduct. There shall be record of changed and deletions.Batch records electronically stored shall beprotected by a suitable back-upLPU 21 22. QUALITY ASSURANCEIS A DYNAMICPROCESSIt is a journey towards thedestination.LPU 22