Aralin 1Milling at sizing: objectives, pagpili ng kagamitan, pass/fail criteria para sa particle sizeNagdedeskripsyon ng milling at sizing objectives, kabilang ang kontrol ng particle size distribution para sa flow at dissolution. Sinusuri ang karaniwang kagamitan, operating parameters, at classification methods. Tinitukoy ang pass o fail criteria at nag-uugnay sa downstream performance.
Impact ng particle size sa performanceMilling equipment types at usesKey operating parameters at risksParticle size analysis methodsSpecification setting at acceptanceAralin 2Pagdating ng hilaw na materyales, sampling at quarantine: identification, sampling plans, release testing requirementsSumasaklaw sa pagdating ng APIs at excipients, GMP-compliant na sampling, quarantine controls, at identification testing. Ipinaliliwanag ang sampling plans, release testing requirements, at dokumentasyon na kinakailangan upang matiyak na ang mga sumusunod na materyales lamang ang pumasok sa produksyon.
GMP requirements para sa material receiptQuarantine at status labeling controlSampling plans at sample integrityIdentity testing at CoA verificationRelease versus rejection decisionsAralin 3In-process analytical controls at release testing: assays, dissolution, disintegration at sterility considerations kung naaangkopNagdedeskripsyon ng in-process analytical controls at final release testing para sa tablets. Sumasaklaw sa assay, content uniformity, dissolution, at disintegration. Tinitugunan ang sterility at bioburden considerations kung naaangkop, plus method validation at data review.
Assay at content uniformity testsDissolution method design at limitsDisintegration testing at criteriaMicrobial at sterility aspectsReview at approval ng test dataAralin 4Compression: tablet press modes, tooling selection, in-process controls (weight, hardness, thickness, visual inspection)Sumasaklaw sa tablet compression principles, press modes, at tooling selection. Nagdedeskripsyon ng in-process controls para sa weight, hardness, thickness, friability, at appearance. Ipinaliliwanag ang set-up, adjustment, at troubleshooting upang mapanatili ang consistent na kalidad ng tablet.
Tablet press types at operationTooling design at material choiceSet-up, start-up at ramp-up checksRoutine compression IPC testingCommon compression defectsAralin 5Drying at moisture control: dryer types, endpoint determination, impact sa downstream processing at QC checksSinusuri ang drying operations pagkatapos ng wet granulation, kabilang ang tray, fluid bed, at vacuum dryers. Tinatalakay ang moisture targets, endpoint determination methods, at kung paano nakakaapekto ang residual moisture sa flow, compression, stability, at in-process quality checks.
Dryer types at selection factorsMoisture targets at specificationsEndpoint determination techniquesEffect ng moisture sa compressionIn-process moisture testing methodsAralin 6Coating (optional): coating purposes, coater types, critical parameters at in-process checksNag-eeksplora ng coating bilang optional step, kabilang ang functional at aesthetic purposes. Sinusuri ang coater types, critical process parameters, at formulation aspects. Nagdedetalye ng in-process checks tulad ng weight gain, appearance, at defect monitoring.
Film versus sugar coating rolesPan at fluid bed coater typesCritical coating parametersCoating solution at suspension prepIn-process coating inspectionAralin 7Granulation options at selection criteria: wet granulation vs dry/granulation-less direct compression at purpose ng granulationIpinaliliwanag ang granulation options, kabilang ang wet granulation, dry granulation, at direct compression. Inihahalintulad ang selection criteria tulad ng material properties, stability, at scale-up. Nagdedeskripsyon kung paano mapapabuti ng granulation ang flow, compressibility, at content uniformity.
Objectives ng granulation sa tabletsWet granulation process overviewDry granulation at roller compactionDirect compression feasibility checksFormulation at material considerationsAralin 8Overview flowchart: material receipt hanggang finished packaged tablets na may sequence ng process stepNagpapakita ng overall tablet manufacturing flow mula sa material receipt hanggang final packaging. Nagbibigay-diin sa key decision points, optional steps tulad ng coating, at linkages sa pagitan ng unit operations, in-process controls, at dokumentasyon para sa batch records.
Typical solid dose process mapCritical decision at hold pointsOptional coating at rework pathsPag-uugnay ng IPCs sa process stepsBatch record at flowchart alignmentAralin 9Secondary packaging at labeling: batch traceability, serialization considerations, at final product release samplingIpinaliliwanag ang secondary packaging, labeling, at aggregation. Sumasaklaw sa batch traceability, serialization requirements, at tamper-evident features. Nagdedeskripsyon ng sampling para sa final product release at dokumentasyon na kinakailangan para sa regulasyon compliance.
Cartoning at aggregation stepsLabel content at control checksSerialization at data managementBatch traceability at recallsFinal release sampling strategyAralin 10Primary packaging: tablet containment options (blister vs bottle), line speed matching, in-line weight/visual checksNagdedetalye ng primary packaging options tulad ng blisters at bottles, kabilang ang material selection at barrier properties. Tinatalakay ang line speed matching, in-line weight at visual checks, at controls na nagpoprotekta sa integridad ng produkto at kaligtasan ng pasyente.
Blister versus bottle selectionPackaging material compatibilityLine speed at equipment balanceIn-line weight at count checksAutomated visual inspectionAralin 11Dispensing at weighing: controlled weighing procedures, anti-mixup measures, at dokumentasyonNag-eeksplora ng controlled weighing ng APIs at excipients, kabilang ang pagpili ng kagamitan, calibration, at environmental controls. Nagdedetalye ng anti-mixup measures, reconciliation, at dokumentasyon practices na nagpapanatili ng traceability at nag-iwas sa cross-contamination.
Weighing room design at controlsBalance qualification at calibrationLabeling at anti-mixup strategiesMaterial reconciliation at yieldsWeighing documentation standardsAralin 12Final blending at lubricants: sequence, segregation risks, segregation mitigation at in-process testingNakatuon sa final blending at pagdaragdag ng lubricants, glidants, at external phase excipients. Tinitugunan ang sequence ng pagdaragdag, segregation risks, at mitigation strategies. Sumasaklaw sa in-process tests na nagpapatunay ng kalidad ng blend bago ang compression.
Roles ng lubricants at glidantsOrder ng pagdaragdag at mixing timeSegregation mechanisms at risksSegregation mitigation techniquesFinal blend IPCs at releaseAralin 13Blending: blender types, blend time determination, blend uniformity testing (hal. sampling plan at assay limits)Nagdedetalye ng blender types at operating principles, kabilang ang V-blenders, bin blenders, at high-shear systems. Ipinaliliwanag ang blend time determination, sampling plans, at statistical evaluation ng blend uniformity upang matiyak ang consistent assay sa buong batch.
Pagpili ng blender typeBlend order at loading strategyPagpapatunay ng optimal blend timeBlend sampling plans at locationsUniformity criteria at investigations
