Approval Part 3: Process acceptance

1947 days ago, 669 views
PowerPoint PPT Presentation
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

Slide 1

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

Slide 2

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

Slide 3

Validation Introduction

Slide 4

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

Slide 5

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

Slide 6

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

Slide 7

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

Slide 8

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

Slide 9

Validation Determining basic control focuses

Slide 10

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

Slide 11

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

Slide 12

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

Slide 13

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

Slide 14

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

Slide 15

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

Slide 16

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

Slide 17

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

Slide 18

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

Slide 19

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

Slide 20

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

Slide 21

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"

Slide 22

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