Lesson 1Milling and sizing: objectives, equipment choices, pass/fail criteria for particle sizeThis lesson describes milling and sizing goals, controlling particle size for better flow and dissolution. It reviews equipment types, parameters, and methods, 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 handles API and excipient receipt, GMP sampling, quarantine, and identity tests. It covers sampling strategies, release tests, and records to confirm only suitable materials proceed to 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 outlines in-process tests and final release checks for tablets, including assays, uniformity, dissolution, and disintegration. It includes sterility where needed, plus method checks and data evaluation.
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 explains tablet compression basics, press operations, and tooling choices. It details checks for weight, hardness, thickness, friability, and looks, with setup 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 reviews drying after wet granulation using tray, fluid bed, or vacuum dryers. It discusses moisture goals, endpoint methods, and how leftover moisture affects flow, pressing, 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 checksThis lesson looks at optional coating for function or looks, reviewing coater types, key parameters, and formulation. It covers checks like weight gain, appearance, and defect tracking during process.
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 choices like wet, dry, or direct compression, comparing based on material traits, stability, and scaling. It shows how granulation boosts 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 presents the full tablet making flow from receipt to packaging, noting key choices, optional steps like coating, and connections between operations, checks, 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, labeling, and grouping, including traceability, serialization, and tamper-proof features. It describes final sampling and records for regulatory approval.
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 or bottles, material choices, and barriers. It discusses speed matching, inline checks for weight and visuals to safeguard 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 explores safe weighing of APIs and excipients, equipment, calibration, and controls. It details anti-mixup steps, checks, and records to ensure tracking and avoid 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 with lubricants and glidants, addition order, segregation risks, and fixes. It covers 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, and high-shear, principles, time setting, sampling, and stats for uniformity to guarantee even assay in the batch.
Selection of blender typeBlend order and loading strategyDetermining optimal blend timeBlend sampling plans and locationsUniformity criteria and investigations
