Lesson 1Milling and sizing: objectives, equipment choices, pass/fail criteria for particle sizeOutlines milling and sizing goals, including particle size distribution control for flow and dissolution. Covers typical equipment, parameters, and classification. Sets pass/fail standards and connects to later steps.
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 requirementsHandles API and excipient receipt, GMP sampling, quarantine, and ID testing. Details sampling plans, release tests, and records to guarantee only suitable materials proceed to production.
GMP requirements for material receiptQuarantine and status labelling 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 relevantCovers in-process analytics and final release tests for tablets, including assay, uniformity, dissolution, disintegration. Includes sterility where needed, 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)Explains tablet compression basics, press types, and tooling choices. Details controls for weight, hardness, thickness, friability, appearance, plus setup, tweaks, 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 checksLooks at drying post-wet granulation, covering tray, fluid bed, vacuum dryers. Discusses moisture goals, endpoint methods, and residual moisture effects on flow, compression, stability, and checks.
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 checksExamines optional coating for function and looks. Reviews coater types, key parameters, formulation. Covers checks like weight gain, appearance, 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 granulationExplains granulation choices: wet, dry, direct compression. Compares criteria like properties, stability, scaling. Shows how granulation boosts flow, compressibility, 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 sequenceShows overall tablet making flow from receipt to packaging. Notes key decisions, optional steps like coating, links 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 labelling: batch traceability, serialisation considerations, and final product release samplingCovers secondary packaging, labelling, aggregation. Includes traceability, serialisation, tamper-proofing. Details final release sampling and compliance records.
Cartoning and aggregation stepsLabel content and control checksSerialisation and data managementBatch traceability and recallsFinal release sampling strategyLesson 10Primary packaging: tablet containment options (blister vs bottle), line speed matching, in-line weight/visual checksDetails primary options like blisters, bottles, materials, barriers. Covers speed matching, in-line checks for weight, visuals, protecting integrity 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 documentationCovers controlled weighing of APIs, excipients, equipment, calibration, environment. Details anti-mixup, reconciliation, records for traceability, no contamination.
Weighing room design and controlsBalance qualification and calibrationLabelling and anti-mixup strategiesMaterial reconciliation and yieldsWeighing documentation standardsLesson 12Final blending and lubricants: sequence, segregation risks, segregation mitigation and in-process testingFocuses on final blending, adding lubricants, glidants, excipients. Covers addition order, segregation risks, fixes. Includes tests to check blend before compression.
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)Details blender types, principles: V, bin, high-shear. Explains time setting, sampling, stats for uniformity to ensure even assay in batch.
Selection of blender typeBlend order and loading strategyDetermining optimal blend timeBlend sampling plans and locationsUniformity criteria and investigations
