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From Tradition to Pharma: GACP Compliance for Cannabis Operators
Introductory Phase – Cultural and Legal Restructuring
Module -1 – Cultural Paradigms: Transitioning from the Gray Market to Regulated Systems
Phase 0 – Foundational Alignment
Module A – GACP Fundamentals: Conceptual Structure, GMP Comparison, and ALCOA+ Principles
Module 0 – Project Kickoff & Gap Analysis: Methodology, Tools, and Timeline
Phase 1 – Regulatory and Strategic Framework
Module 1 – Regulatory Mapping, Licensing, and Stakeholder Identification
Module 2 – International Legal Framework on Narcotics, Import/Export, and GMP/GDP Alignment
Phase 2 – Environmental & Infrastructural Context
Module 3 – Site Selection & Environmental Suitability Assessment
Module 4 – Infrastructure Design Based on Unidirectional Flow and Sanitizability Principles
Phase 3 – Phylogenesis, Inputs and Active Cultivation
Module 5 – Genetics, Traceability, and Propagation
Module 6 – Qualification of Agronomic Inputs: Fertilizers, Water, Substrates
Module 7 – Integrated Cultivation Management & IPM: Preventive and Biological Control Approach
Phase 4 – Harvest, Post-Harvest and Preservation
Module 8 – Harvest Operations: Phenological Timing and Batch Integrity
Module 9 – Drying, Curing, and Trimming: Balancing Stability and Terpene Profile
Phase 5 – Storage & Quality Control
Module 10 – Storage & Intermediate Logistics: GDP Compliance and Physicochemical Stability
Module 11 – Data Governance & ALCOA+: Metadata Structuring and Control
Module 12 – Quality Management System (QMS): Architecture, KPIs, and Periodic Review
Module 13 – Human Resources Management & Operational Training
Module 14 – Analytical Testing, Method Validation & Batch Release
Module 15 – Stability and Retest Strategies: ICH Protocols and Trending Analysis
Phase 6 – Occupational Safety & Preventive Controls
Module 16 – EHS & Waste Management: Regulatory Compliance and Risk Mitigation
Module 17 – Risk Analysis & HACCP: CCP Identification and Deviation Management
Module 18 – Internal Audit and Continuous Improvement: Methodology and Compliance Culture
Submodule 18.1 – Strategic Value of Third-Party Audits
Phase 7 – Certification, External Audits and Market Access
Module 19 – Certification Audit Preparation & Inspection Conduct
Module 20 – Export Logistics & Access to Regulated Markets
Phase 8 – Supplier Management & Digital Traceability
Module 21 – Supplier Qualification & Performance Monitoring
Module 22 – Digital Traceability: Software Validation, Interoperability & GAMP5 Architecture
Phase 9 – Continuous Compliance & Operational Optimization
Module 23 – Post-Certification Maintenance & Product Quality Review
Module 24 – Sustainability, ESG & Carbon Risk Mitigation
Module 25 – Lean Cannabis Manufacturing, Six Sigma, and Compliance ROI
Phase 10 – National Adaptation & Commercial Strategy
Module 26 – GACP within National Legal Contexts
Module 27 – Market Access Strategy & B2B Positioning
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Module 7 – Integrated Cultivation Management & IPM: Preventive and Biological Control Approach
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