Approval Part 3: Process acceptance

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Acceptance. Goals To review:Validation, hazard investigation, and basic strides of processingPoints to consider in procedure acceptance of:solid measurement mixingtablet compressionsterilizationFinalization of approval. Presentation. Acceptance. Approval. Solid, repeatable, under control At slightest initial 3 back to back clumps - repeatableMust research failuresThe method of reasoning ought to be reported if ex

Presentation Transcript

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Supplementary Training Modules on Good Manufacturing Practices Validation Part 3: Process approval

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Validation Objectives To survey: Validation, hazard examination, and basic strides of preparing Points to consider in process approval of: strong measurement blending tablet compression sanitization Finalization of approval

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Validation Introduction

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Validation Reliable, repeatable, under control At minimum initial 3 successive clumps - repeatable Must research disappointments The basis ought to be archived if trial strategy is changed report deviations, choice s and thinking Does not enhance procedures Should not approve awful procedures

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Validation Design user or handle necessities Install installation capability Operate operational capability Validate performance capability and prepare approval Review periodically (+ change control) DQ, IQ, OQ and PQ

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Validation Critical variables or parameters Need to be resolved Need to be observed amid approval May influence the nature of the item

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Validation Setting Limits Marketing approval limits soundness determinations Release particular Validation limits Marketing authorisation limits in view of security details Batch discharge limits Validation limits

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Validation Determining basic control point case of a tablet granulation prepare Particle estimate dissemination of the active(s) Blending time for the powder Granulating time and speed , Amount of grinding liquid cover focus Drying time - last dampness content , granule particle measure circulation Granule dynamic substance and homogeneity , mixing time of outer stage

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Validation Determining basic control focuses

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Validation Solid dosage blending (1) Homogeneity in mixing – the way to quality ! Examining technique Sample site, name, holder Storage Transport Sample cheat

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Validation Solid dosage blending (2) In situ examination Methods of investigation Statistical examination between clump intra-bunch inside example site

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Validation Tablet pressure factors Fill volume Pre-pressure constrain, pressure compel Turntable speed Dwell time Granule size and nourish Ejection drive, oil

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Validation Tablet pressure parameters Mass Hardness Moisture Friability Disintegration Dissolution Thickness Tablet covering factors S ask rate Inlet and outlet air temp Coating weight

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Validation Lethality of cycle D esteem Z esteem F esteem F o v a lue min 8 Moist warmth sanitization "Z"

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Validation Sterilization approval (1) Sterility test Physical estimations Chemical and natural pointers Loading designs

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Validation Sterilization approval (2) Cooling liquid or gas Automated process Leak tests Control instrumentation Steam quality Heat appropriation

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Validation Dry warmth disinfection Parameters Air course , constructive gaseous tension , HEPA channel Advantages microorganisms obliterated depyrogenation conceivable Disadvantages poor warmth exchange higher temperatures for long stretches

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Validation Process variety Controllable reasons for variety may include: Temperature, moistness Variations in electrical supply Vibration Environmental contaminants Light Human elements Variability of materials Wear and tear of hardware

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Validation Change control Must be a survey methodology for approved procedures From time to time changes might be vital Documented change control system required " Like for like" changes don't require re-approval

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Validation Mixing approval fluid and strong measurements switch control and scale up Mixer sort and size Batch scrutinize Pilot ponder scale Limit on the extent of the scale up

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Validation Finalization of approval process Final report required Summarize and reference conventions and results Conclusion required: "Is the procedure substantial" Final report ought to be assessed and affirmed by the approval group "approved individual"

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Validation Group Session You are given a tablet producing stream graph to study List the basic strides that are required to be approved List the basic gear required to be qualified Identify the factors and develop a table as coordinated