Lesson 1Milling and sizing: objectives, equipment choices, pass/fail criteria for particle sizeCovers milling and sizing goals, controlling particle size for flow and dissolution. Looks at common equipment, settings, and checks, linking 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 requirementsHandles API and excipient receipt, GMP sampling, quarantine, and ID tests. Explains plans, release tests, and records to ensure only good materials go into 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 relevantDetails in-process tests and final release for tablets, including assay, uniformity, dissolution, disintegration, plus sterility where needed, with method checks and data review.
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)Covers tablet pressing basics, press types, tooling choices. Details checks for weight, hardness, thickness, friability, 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 checksLooks at drying after wet granulation, using tray, fluid bed, vacuum dryers. Covers moisture goals, endpoint methods, and effects on 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 checksExplores optional coating for function and looks. Reviews coater types, key settings, formulation, and checks like weight gain, appearance, defects.
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 based on materials, stability, scale-up, improving flow, pressing, 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 full tablet making flow from receipt to packaging, key decisions, optional steps like coating, links between operations, checks, 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 samplingCovers secondary packaging, labeling, aggregation. Includes traceability, serialization, tamper-proofing, final sampling, records for compliance.
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 checksDetails primary packaging like blisters, bottles, materials, barriers. Covers speed matching, in-line checks for product 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, controls. Anti-mixup, reconciliation, records to 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 testingFocuses on final blending, lubricants, glidants. Addition order, segregation risks, fixes, tests for 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)Details blender types like V, bin, high-shear. Blend time, sampling, stats for uniformity across batch.
Selection of blender typeBlend order and loading strategyDetermining optimal blend timeBlend sampling plans and locationsUniformity criteria and investigations
