Lesson 1Milling and sizing: objectives, equipment choices, pass/fail criteria for particle sizeDescribe milling and sizing objectives, including control of particle size distribution for flow and dissolution. Review common equipment, operating parameters, and classification methods. Define pass or fail criteria and link to downstream performance in local terms.
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 requirementsCover receipt of APIs and excipients, GMP-compliant sampling, quarantine controls, and identification testing. Explain sampling plans, release testing requirements, and documentation needed to ensure only conforming materials enter production here.
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 relevantDescribe in-process analytical controls and final release testing for tablets. Cover assay, content uniformity, dissolution, and disintegration. Address sterility and bioburden considerations where relevant, plus method validation and data review for us.
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)Cover tablet compression principles, press modes, and tooling selection. Describe in-process controls for weight, hardness, thickness, friability, and appearance. Explain 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 checksExamine drying operations after wet granulation, including tray, fluid bed, and vacuum dryers. Discuss moisture targets, endpoint determination methods, and how residual moisture affect 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 checksExplore coating as an optional step, including functional and aesthetic purposes. Review coater types, critical process parameters, and formulation aspects. Detail 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 granulationExplain granulation options, including wet granulation, dry granulation, and direct compression. Compare selection criteria such as material properties, stability, and scale-up. Describe how granulation improve 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 sequencePresent di overall tablet manufacturing flow from material receipt to final packaging. Highlight 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 labeling: batch traceability, serialization considerations, and final product release samplingExplain secondary packaging, labeling, and aggregation. Cover batch traceability, serialization requirements, and tamper-evident features. Describe sampling for final product release and documentation needed for regulatory compliance in we country.
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 checksDetail primary packaging options such as blisters and bottles, including material selection and barrier properties. Discuss line speed matching, in-line weight and visual checks, and controls dat 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 documentationExplore controlled weighing of APIs and excipients, including equipment selection, calibration, and environmental controls. Detail anti-mixup measures, reconciliation, and documentation practices dat 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 testingFocus on final blending and addition of lubricants, glidants, and external phase excipients. Address sequence of addition, segregation risks, and mitigation strategies. Cover in-process tests dat 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)Detail blender types and operating principles, including V-blenders, bin blenders, and high-shear systems. Explain blend time determination, sampling plans, and statistical evaluation of blend uniformity to ensure consistent assay across di batch.
Selection of blender typeBlend order and loading strategyDetermining optimal blend timeBlend sampling plans and locationsUniformity criteria and investigations
