// Expanded Drug Development Flowchart (YES/NO)
digraph {
rankdir=TB size=12
Start [label=Start]
LabTrials [label="Prepare Lab Trials?"]
PreForm [label="Conduct Pre-Formulation Studies
(API characterization: solubility, stability, mechanical/chemical properties,
degradation potential)"]
SuccessfulPreForm [label="Successful?"]
SelectExcipients [label="Select Final Excipients"]
TrialBatch [label="Prepare Trial Batch"]
Reformulate [label="Reformulate / Adjust Parameters"]
PilotBatch [label="Prepare Pilot Batch"]
QAQC [label="Conduct QA/QC Tests
(assay, content uniformity, dissolution, stability, microbial)"]
PassQAQC [label="Pass QA/QC Tests?"]
ScaleUp [label="Scale Up to Small Production / Validation Batch"]
AdjustFormulation [label="Adjust Formulation / Process"]
ValidationBatch [label="Validation Batch Ready"]
ProcessValidation [label="Conduct Process Validation"]
ProcessSpec [label="Process Meets Specifications?"]
CommercialPlanning [label="Proceed to Commercial Production Planning"]
RootCause [label="Identify Root Cause"]
CorrectiveAction [label="Corrective Action"]
SelectPackaging [label="Select Primary & Secondary Packaging"]
PackagingStudies [label="Conduct Compatibility / Stability Studies"]
PackagingSuit [label="Packaging suitable & compatible?"]
PackagingReport [label="Prepare Packaging Development Report"]
ModifyPackaging [label="Modify Packaging Material / Design"]
PrepareDossier [label="Prepare Dossier (CTD/eCTD)"]
SubmitApproval [label="Submit for Approval"]
ApprovalGranted [label="Approval Granted?"]
MarketAuthorization [label="Proceed to Market Authorization & Commercial
Production"]
RegulatoryComments [label="Address Regulatory Comments"]
CommercialBatch [label="Commercial Batch Production"]
ReleaseTest [label="QA/QC Release Testing
(Pass Release Criteria?)"]
MarketRelease [label="Product Market Release"]
InvestigateBatch [label="Investigate Batch"]
CorrectiveProd [label="Corrective Actions"]
MonitorMarket [label="Monitor Market Feedback"]
OngoingStability [label="Conduct Ongoing Stability Studies"]
AdverseFindings [label="Any Adverse Findings / OOS Results?"]
CAPA [label="Initiate CAPA"]
RoutineProduction [label="Continue Routine Production & Market Monitoring"]
ReviewPerformance [label="Review CQAs, CPPs, Manufacturing Performance,
Supply Chain"]
Improvement [label="Opportunities for Improvement Identified?"]
ImplementOptim [label="Implement Process Optimization / Reformulation /
Scale-up Enhancements"]
MaintainProcess [label="Maintain Current Process → Routine Review Cycle"]
Start -> LabTrials
LabTrials -> PreForm [label=Yes]
PreForm -> SuccessfulPreForm
SuccessfulPreForm -> SelectExcipients [label=Yes]
SuccessfulPreForm -> Reformulate [label=No]
Reformulate -> PreForm
SelectExcipients -> TrialBatch
TrialBatch -> PilotBatch
PilotBatch -> QAQC
QAQC -> PassQAQC
PassQAQC -> ScaleUp [label=Yes]
PassQAQC -> AdjustFormulation [label=No]
AdjustFormulation -> PilotBatch
ScaleUp -> ValidationBatch
ValidationBatch -> ProcessValidation
ProcessValidation -> ProcessSpec
ProcessSpec -> CommercialPlanning [label=Yes]
ProcessSpec -> RootCause [label=No]
RootCause -> CorrectiveAction
CorrectiveAction -> ValidationBatch
CommercialPlanning -> SelectPackaging
SelectPackaging -> PackagingStudies
PackagingStudies -> PackagingSuit
PackagingSuit -> PackagingReport [label=Yes]
PackagingSuit -> ModifyPackaging [label=No]
ModifyPackaging -> PackagingStudies
PackagingReport -> PrepareDossier
PrepareDossier -> SubmitApproval
SubmitApproval -> ApprovalGranted
ApprovalGranted -> MarketAuthorization [label=Yes]
ApprovalGranted -> RegulatoryComments [label=No]
RegulatoryComments -> PrepareDossier
MarketAuthorization -> CommercialBatch
CommercialBatch -> ReleaseTest
ReleaseTest -> MarketRelease [label=Yes]
ReleaseTest -> InvestigateBatch [label=No]
InvestigateBatch -> CorrectiveProd
CorrectiveProd -> CommercialBatch
MarketRelease -> MonitorMarket
MonitorMarket -> OngoingStability
OngoingStability -> AdverseFindings
AdverseFindings -> CAPA [label=Yes]
AdverseFindings -> RoutineProduction [label=No]
CAPA -> CorrectiveProd
RoutineProduction -> ReviewPerformance
ReviewPerformance -> Improvement
Improvement -> ImplementOptim [label=Yes]
Improvement -> MaintainProcess [label=No]
ImplementOptim -> TrialBatch
}