Lesson 1Milling and sizing: objectives, equipment choices, pass/fail criteria for particle sizeExplains milling and sizing goals, including particle size control for flow and dissolution. Looks at common equipment, operating settings, and classification ways. Sets pass or fail rules and connects to later 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 requirementsCovers arrival of APIs and excipients, GMP sampling, quarantine controls, and identity testing. Explains sampling plans, release testing needs, and papers to ensure only good 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 relevantDescribes in-process analytical controls and final release testing for tablets. Covers assay, content uniformity, dissolution, and disintegration. Deals with sterility and bioburden where needed, plus method validation 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 compression basics, press modes, and tooling choice. Describes in-process controls for weight, hardness, thickness, friability, and looks. Explains setup, adjustment, and fixing to keep tablet quality steady.
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, including tray, fluid bed, and vacuum dryers. Discusses moisture targets, endpoint ways, and how leftover moisture affects flow, compression, stability, and in-process quality 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 coating as an extra step, including functional and look purposes. Reviews coater types, key process settings, and formulation parts. Details in-process checks like weight gain, appearance, and defect watching.
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, including wet, dry, and direct compression. Compares choice rules like material features, stability, and scale-up. Describes how granulation improves flow, compressibility, and content 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 the overall tablet making flow from material arrival to final packaging. Highlights key decision points, extra steps like coating, and links between unit operations, in-process controls, and batch record papers.
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 samplingExplains secondary packaging, labeling, and grouping. Covers batch tracking, serialization needs, and tamper-evident features. Describes sampling for final product release and papers for regulatory following.
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 choices like blisters and bottles, including material pick and barrier features. Discusses line speed matching, in-line weight and visual checks, and controls to protect product wholeness and patient 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 documentationExplores controlled weighing of APIs and excipients, including equipment choice, calibration, and environment controls. Details anti-mixup steps, reconciliation, and paper practices for tracking and preventing cross-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 and adding lubricants, glidants, and external excipients. Addresses addition order, segregation risks, and fixing strategies. Covers in-process tests to check blend quality 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 and working basics, including V-blenders, bin blenders, and high-shear systems. Explains blend time setting, sampling plans, and statistical check of blend uniformity for steady assay across the batch.
Selection of blender typeBlend order and loading strategyDetermining optimal blend timeBlend sampling plans and locationsUniformity criteria and investigations
