Lesson 1Milling and sizing: objectives, equipment choices, pass/fail criteria for particle sizeThis lesson explains milling and sizing goals, controlling particle size for better flow and dissolution. It reviews common equipment, parameters, and classification, defining pass/fail standards linked to later process performance.
Impact of particle size on performanceMilling equipment types and usesKey operating parameters and risksParticle size analysis methodsSpecification setting and acceptanceLesson 2Raw material receipt, sampling and quarantine: identification, sampling plans, release testing requirementsThis lesson discusses API and excipient receipt, GMP sampling, quarantine procedures, and identity checks. It covers sampling strategies, release tests, and records to confirm only approved materials enter production.
GMP requirements for material receiptQuarantine and status labeling controlSampling plans and sample integrityIdentity testing and CoA verificationRelease versus rejection decisionsLesson 3In-process analytical controls and release testing: assays, dissolution, disintegration and sterility considerations where relevantThis lesson details in-process testing and final release for tablets, including assay, uniformity, dissolution, disintegration, and relevant sterility checks, plus method validation and data checks.
Assay and content uniformity testsDissolution method design and limitsDisintegration testing and criteriaMicrobial and sterility aspectsReview and approval of test dataLesson 4Compression: tablet press modes, tooling selection, in-process controls (weight, hardness, thickness, visual inspection)This lesson covers tablet pressing basics, machine modes, tooling choices, and controls for weight, hardness, thickness, friability, appearance, with setup, adjustments, and fixes for steady quality.
Tablet press types and operationTooling design and material choiceSet-up, start-up and ramp-up checksRoutine compression IPC testingCommon compression defectsLesson 5Drying and moisture control: dryer types, endpoint determination, impact on downstream processing and QC checksThis lesson examines post-wet granulation drying using tray, fluid bed, vacuum dryers, moisture goals, endpoint methods, and effects of leftover moisture on flow, pressing, stability, and quality tests.
Dryer types and selection factorsMoisture targets and specificationsEndpoint determination techniquesEffect of moisture on compressionIn-process moisture testing methodsLesson 6Coating (optional): coating purposes, coater types, critical parameters and in-process checksThis lesson explores optional coating for function and looks, covering coater types, key parameters, formulation, and checks like weight gain, appearance, and defect tracking.
Film versus sugar coating rolesPan and fluid bed coater typesCritical coating parametersCoating solution and suspension prepIn-process coating inspectionLesson 7Granulation options and selection criteria: wet granulation vs dry/granulation-less direct compression and purpose of granulationThis lesson explains granulation methods like wet, dry, direct compression, selection based on material traits, stability, scale-up, improving flow, pressing, and uniformity.
Objectives of granulation in tabletsWet granulation process overviewDry granulation and roller compactionDirect compression feasibility checksFormulation and material considerationsLesson 8Overview flowchart: material receipt to finished packaged tablets with process step sequenceThis lesson shows the full tablet making flow from receipt to packaging, key choices, optional steps like coating, and connections between operations, controls, and batch records.
Typical solid dose process mapCritical decision and hold pointsOptional coating and rework pathsLinking IPCs to process stepsBatch record and flowchart alignmentLesson 9Secondary packaging and labeling: batch traceability, serialization considerations, and final product release samplingThis lesson covers secondary packaging, labelling, aggregation, batch tracking, serialisation, tamper-proofing, final sampling, and compliance records.
Cartoning and aggregation stepsLabel content and control checksSerialization and data managementBatch traceability and recallsFinal release sampling strategyLesson 10Primary packaging: tablet containment options (blister vs bottle), line speed matching, in-line weight/visual checksThis lesson details primary packaging like blisters, bottles, materials, barriers, line speeds, inline checks for weight, visuals, protecting product and safety.
Blister versus bottle selectionPackaging material compatibilityLine speed and equipment balanceIn-line weight and count checksAutomated visual inspectionLesson 11Dispensing and weighing: controlled weighing procedures, anti-mixup measures, and documentationThis lesson covers safe weighing of APIs, excipients, equipment, calibration, environment, anti-mixup, reconciliation, records for tracking and no contamination.
Weighing room design and controlsBalance qualification and calibrationLabeling and anti-mixup strategiesMaterial reconciliation and yieldsWeighing documentation standardsLesson 12Final blending and lubricants: sequence, segregation risks, segregation mitigation and in-process testingThis lesson focuses on final blending, lubricant addition, sequence, segregation risks, fixes, and tests to confirm blend quality before pressing.
Roles of lubricants and glidantsOrder of addition and mixing timeSegregation mechanisms and risksSegregation mitigation techniquesFinal blend IPCs and releaseLesson 13Blending: blender types, blend time determination, blend uniformity testing (e.g., sampling plan and assay limits)This lesson details blender types like V, bin, high-shear, time setting, sampling, stats for uniform assay across batch.
Selection of blender typeBlend order and loading strategyDetermining optimal blend timeBlend sampling plans and locationsUniformity criteria and investigations
