Lesson 1Milling and sizing: objectives, equipment choices, pass/fail criteria for particle sizeDescribes milling and sizing objectives, including control of particle size distribution for flow and dissolution. Reviews common equipment, operating parameters, and classification methods. Defines pass or fail criteria and links to downstream 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 receipt of APIs and excipients, GMP-compliant sampling, quarantine controls, and identification testing. Explains sampling plans, release testing requirements, and documentation needed to ensure only conforming 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. Addresses sterility and bioburden considerations where relevant, 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 principles, press modes, and tooling selection. Describes in-process controls for weight, hardness, thickness, friability, and appearance. Explains set-up, adjustment, and troubleshooting to maintain consistent tablet 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 checksExamines drying operations after wet granulation, including tray, fluid bed, and vacuum dryers. Discusses moisture targets, endpoint determination methods, and how residual 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 optional step, including functional and aesthetic purposes. Reviews coater types, critical process parameters, and formulation aspects. Details in-process checks such as weight gain, appearance, and defect monitoring.
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 options, including wet granulation, dry granulation, and direct compression. Compares selection criteria such as material properties, 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 sequencePresents the overall tablet manufacturing flow from material receipt to final packaging. Highlights key decision points, optional steps such as coating, and linkages between unit operations, in-process controls, and documentation for 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 samplingExplains secondary packaging, labelling, and aggregation. Covers batch traceability, serialisation requirements, and tamper-evident features. Describes sampling for final product release and documentation needed for regulatory 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 options such as blisters and bottles, including material selection and barrier properties. Discusses line speed matching, in-line weight and visual checks, and controls that protect product integrity 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 selection, calibration, and environmental controls. Details anti-mixup measures, reconciliation, and documentation practices that maintain traceability and prevent 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 addition of lubricants, glidants, and external phase excipients. Addresses sequence of addition, segregation risks, and mitigation strategies. Covers in-process tests that verify 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 operating principles, including V-blenders, bin blenders, and high-shear systems. Explains blend time determination, sampling plans, and statistical evaluation of blend uniformity to ensure consistent assay across the batch.
Selection of blender typeBlend order and loading strategyDetermining optimal blend timeBlend sampling plans and locationsUniformity criteria and investigations
