Lesson 1Milling and sizing: objectives, equipment choices, pass/fail criteria for particle sizeThis lesson describes milling and sizing goals, controlling particle size for flow and dissolution. It reviews common equipment, parameters, and methods, defining pass/fail criteria linked to later performance in local production.
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 requirementsThis lesson handles API and excipient receipt, GMP sampling, quarantine, and ID testing. It explains plans, release tests, and docs to ensure only good materials enter production in Eritrean settings.
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 relevantThis lesson outlines in-process analytics and release tests for tablets, covering assay, uniformity, dissolution, disintegration, and sterility where needed, plus 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)This lesson covers tablet compression basics, press modes, tooling picks, and controls for weight, hardness, thickness, friability, appearance, with setup and troubleshooting for quality in Eritrea.
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 checksThis lesson examines drying after wet granulation, using tray, fluid bed, vacuum dryers, moisture targets, endpoint methods, and effects on flow, compression, stability, with 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 checksThis lesson explores optional coating for function and looks, reviewing coater types, parameters, formulation, and checks like weight gain, appearance, defect monitoring in local plants.
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 granulationThis lesson explains granulation choices like wet, dry, direct compression, criteria based on properties, stability, scale-up, improving flow, compressibility, uniformity in Eritrean contexts.
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 sequenceThis lesson shows tablet manufacturing flow from receipt to packaging, key decisions, optional steps like coating, linking operations, controls, docs for batch records in Eritrea.
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 samplingThis lesson explains secondary packaging, labeling, aggregation, traceability, serialization, tamper features, sampling for release, docs for compliance in pharmaceutical production.
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 checksThis lesson details primary packaging like blisters, bottles, materials, barriers, line speed, weight/visual checks, controls for integrity and safety in local facilities.
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 documentationThis lesson covers controlled weighing of APIs, excipients, equipment, calibration, controls, anti-mixup, reconciliation, docs for traceability, no cross-contamination in Eritrea.
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 testingThis lesson focuses on final blending, lubricants, glidants, addition sequence, segregation risks, mitigation, tests for blend quality before compression in production.
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)This lesson details blender types, principles like V, bin, high-shear, time determination, sampling, stats for uniformity, ensuring consistent assay in batches.
Selection of blender typeBlend order and loading strategyDetermining optimal blend timeBlend sampling plans and locationsUniformity criteria and investigations
