Annex 1 (2022) aligned. Cannabis-specific. Practitioner-authored. Every document comes with instructional guidance for facility-specific completion — and three ways to engage depending on your internal resource.
For companies with internal QA or validation resource. Download immediately. Every template includes instructional guidance in blue italic text throughout — so your team knows exactly what to complete, verify and adapt for your facility.
Your team completes 80% of the document using the template. An ECI practitioner reviews the draft, provides written comments and confirms it meets EU GMP expectations for your facility type and target markets.
You provide facility drawings, product list, process flow and equipment list. ECI converts the template into a site-specific, facility-ready GMP document. The fastest route from blank page to controlled document.
The four foundational documents every pharmaceutical cannabis facility needs. Purchased individually at €1,146 — available as a bundle at a significant saving. All documents are Annex 1 (2022) aligned with cannabis-specific content and instructional guidance throughout.
Bundle available when all four documents are published. Register interest to be notified and receive the bundle price.
The definitive cannabis GMP contamination control strategy template. Annex 1 (2022) compliant with executive dashboard, 35-failure-mode FMEA, contamination pathway logic, integrated control framework and full governance model.
The strategic qualification and validation framework for a pharmaceutical cannabis facility. Covers the full validation lifecycle from facility commissioning through process validation, cleaning validation and ongoing monitoring.
The primary regulatory reference document for your manufacturing site. The SMF is the document inspectors read before visiting and the foundation of your regulatory submission package.
The qualification framework for your environmental monitoring programme. Establishes risk-justified sampling locations, statistically derived alert and action limits, and a monitoring schedule proportionate to your classified zone classification.
The master cleaning validation plan for shared pharmaceutical cannabis manufacturing equipment. Includes PDE-based limit calculation methodology, swab recovery requirements, worst-case location rationale and the cannabis-specific THC-to-CBD cross-contamination approach.
The overarching quality management system document for a pharmaceutical cannabis facility. Establishes the quality policy, organisational structure, key quality processes and the management review framework required by EU GMP Part I and ICH Q10.
The supplier qualification framework covering GACP cannabis starting material suppliers, excipient and packaging suppliers, and contract service providers. Includes the GACP supplier audit programme and cannabis-specific incoming material specification requirements.
The ECI Pharmaceuticalisation Index™ Professional Assessment Report template. A 35–50 page structured report framework for consultants and QA professionals conducting pharmaceutical maturity assessments of cannabis manufacturing facilities.
45 questions. 8 minutes. An instant maturity score across 10 GMP dimensions with personalised document and course recommendations. The fastest way to understand which documents your facility needs first.
For cannabis facilities building their GMP system from the ground up — Quality Manual, VMP, CCS, SMF, Validation Strategy, Supplier Qualification Programme and more. Contact ECI to discuss a complete documentation package.
ECI offers professional GMP templates for Contamination Control Strategy (CCS), Validation Master Plan (VMP), Site Master File (SMF), Environmental Monitoring Programme Qualification (EMPQ), Cleaning Validation Plan (CVP), Quality Management System Manual, Supplier Qualification Programme, and the PI Professional Assessment Report Template.
ECI offers three service tiers: Buy Template (download immediately from €249), Review My Draft (your team completes 80%, ECI reviews from €750), and Build It For Me (ECI develops the full site-specific document from €3,500).
Yes. All ECI GMP document templates are aligned to EU GMP Annex 1 (2022) requirements and include cannabis-specific content not found in generic pharmaceutical templates. Each template includes instructional guidance throughout.