Lesson 1Milling and sizing: objectives, equipment choices, pass/fail criteria for particle sizeOutlines milling and sizing goals, including particle size control for flow and dissolution. Reviews common equipment, parameters, and methods. Sets pass/fail criteria and connects to downstream results in local manufacturing.
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 arrival of APIs and excipients, GMP sampling, quarantine, and ID testing. Covers sampling plans, release tests, and docs to ensure only good materials enter production in Zimbabwean plants.
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 analytics and final release tests for tablets. Includes assay, uniformity, dissolution, disintegration. Covers sterility where needed, plus method validation and data review for compliance.
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, tooling choice. Describes controls for weight, hardness, thickness, friability, appearance. Explains setup, adjustment, troubleshooting 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, including tray, fluid bed, vacuum dryers. Discusses moisture targets, endpoint methods, and residual moisture effects on flow, compression, 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 parameters, formulation. Details checks like weight gain, appearance, defect monitoring in Zimbabwean production.
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 criteria like material traits, stability, scale-up. Shows how granulation boosts flow, compressibility, 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 overall tablet making flow from receipt to packaging. Highlights decisions, optional steps like coating, links between operations, controls, docs 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 samplingExplains secondary packaging, labeling, aggregation. Covers traceability, serialization, tamper-evident features. Describes sampling for release and docs for compliance in local facilities.
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, material choice, barriers. Discusses speed matching, in-line checks, controls for product safety in Zimbabwe.
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, excipients, equipment, calibration, environment. Details anti-mixup, reconciliation, docs for traceability, no 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, lubricants, glidants addition. Addresses sequence, segregation risks, mitigation. Covers 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, principles like V, bin, high-shear. Explains time determination, sampling, stats for uniformity to ensure consistent assay.
Selection of blender typeBlend order and loading strategyDetermining optimal blend timeBlend sampling plans and locationsUniformity criteria and investigations
