GMP & Compliance
Review equipment design considerations and build-specific documentation to support your cannabis or hemp extraction lab's GMP qualification plan — from FDA cGMP and EU GMP to ASME BPE and ICH Q7. Final compliance depends on your facility, process, validation program, and quality system.
The Prodigy Compliance Pathway
Available compliance pathways may include ASME pressure vessel certification, CRN registration, CE/PED conformity assessment, and hazardous-location electrical configurations, depending on final build, jurisdiction, and customer requirements.
CRN is issued to approved pressure equipment designs by Canadian provincial safety authorities. CE/PED marking applies to pressure equipment placed on the EU market under the Pressure Equipment Directive.
GMP compliance depends on the operator's facility, SOPs, validation, documentation, and quality system. Equipment is designed to support GMP-oriented operations in accordance with FDA 21 CFR, EU GMP EudraLex Volume 4, and ICH Q7 principles.
FDA Current Good Manufacturing Practice
Prodigy systems are designed and documented to support FDA current Good Manufacturing Practice requirements as codified in 21 CFR Parts 210 and 211 (drug manufacturing). Part 820 (Quality System Regulation, now transitioning to ISO 13485 under QMSR) is referenced for quality-system principles applicable to equipment documentation — not because the equipment itself is a regulated medical device. Full GMP documentation — SOPs, batch records, cleaning validation, and change control — is available for all Prodigy systems to support FDA-regulated manufacturing environments. Compliance ultimately depends on the complete operating system: facility, personnel, procedures, and validated processes.
- Equipment designed for cleanability and validation
- 316L SS product-contact surfaces with Ra ≤ 0.8 µm finish available
- Cleaning validation documentation and SOPs
- Change control and deviation management frameworks
- Equipment qualification (IQ/OQ/PQ) documentation packages
EU Good Manufacturing Practice — EudraLex Volume 4
Prodigy systems are engineered to support compliance with EU GMP as defined in EudraLex Volume 4, including Annex 1 (sterile medicinal products) and Annex 15 (qualification and validation). The EU GMP framework is the primary regulatory standard for pharmaceutical manufacturers operating in or exporting to European Union member states.
- Equipment design aligned with EudraLex Volume 4 Annex 1 requirements
- Qualification and validation documentation per Annex 15
- Contamination control strategy documentation
- CE/PED marking available for EU market placement
- Supports EU GMP site authorization and inspection readiness
ICH Q7 — Good Manufacturing Practice for Active Pharmaceutical Ingredients
ICH Q7 is the international harmonized guideline for GMP applicable to the manufacture of active pharmaceutical ingredients (APIs). As the cannabinoid pharmaceutical market matures under Schedule III, ICH Q7 compliance is the critical standard for operators producing cannabinoid APIs for pharmaceutical applications. Prodigy systems are designed to support ICH Q7 compliance throughout the API manufacturing process.
- Equipment design and documentation aligned with ICH Q7 Section 5
- Process validation and analytical method validation support
- Critical process parameter (CPP) and critical quality attribute (CQA) documentation
- Batch record and traceability infrastructure
- Change control and deviation management per ICH Q7 Section 13
ASME BPE — Bioprocessing Equipment Standard
The ASME Bioprocessing Equipment (BPE) standard is the definitive fabrication standard for pharmaceutical and bioprocessing equipment. Prodigy systems are fabricated to ASME BPE-2024 by Mitchell Fabricators — an ASME-certified fabrication partner. ASME BPE certification is the gold standard for pharmaceutical equipment procurement and is required by many pharmaceutical manufacturers as a condition of supplier qualification.
- Fabricated to ASME BPE-2024 by ASME-certified fabricator
- 316L SS with electropolished product-contact surfaces
- Weld inspection and documentation per ASME BPE requirements
- Dimensional and surface finish documentation
- Material traceability certificates for all product-contact components
CRN — Canadian Registration Number
CRN (Canadian Registration Number) registration is required for pressure vessels placed in service in Canadian provinces and territories. Prodigy systems are available with CRN registration for operators in Canada or those requiring Canadian regulatory compliance as part of their market strategy.
- CRN registration available for all pressure vessel configurations
- Registered with Canadian provincial safety authorities
- Supports operators in all Canadian provinces and territories
- Required for legal operation of pressure equipment in Canada
CE Marking / Pressure Equipment Directive
CE marking under the EU Pressure Equipment Directive (PED) 2014/68/EU is required for pressure equipment placed on the EU market. Prodigy systems are available with CE/PED conformity assessment, enabling operators to legally place Prodigy equipment in service in European Union member states.
- CE/PED conformity assessment available
- Applies to pressure equipment placed on the EU market
- Supports EU GMP site authorization
- Technical file and Declaration of Conformity provided
Class I, Division 1 — Hazardous Location Electrical
Class I, Division 1 (C1D1) electrical classification is required for equipment operating in environments where flammable gases or vapors are present under normal operating conditions — the standard for hydrocarbon extraction environments. Prodigy ProX systems are available with C1D1-rated electrical components, enabling legal operation in licensed hydrocarbon extraction facilities.
- C1D1-rated electrical components for hydrocarbon extraction environments
- Compliant with NEC Article 501 and NFPA 70 requirements
- Required for licensed hydrocarbon extraction facilities in most jurisdictions
- PSI certified for use in all 50 U.S. states
- Supports state cannabis licensing and fire marshal approval
Installation, Operational & Performance Qualification
IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) is the pharmaceutical industry's standard validation framework for process equipment. The full GMP documentation and IQ/OQ/PQ validation package is available for all Prodigy systems, enabling operators to complete equipment qualification as part of their FDA or EU GMP validation master plan.
- Installation Qualification (IQ): verifies equipment is installed per design specifications
- Operational Qualification (OQ): verifies equipment operates within specified parameters
- Performance Qualification (PQ): verifies equipment performs consistently under process conditions
- Validation Master Plan (VMP) template and guidance
- Supports FDA process validation guidance and ICH Q7 Section 12 requirements
- Available for all Prodigy system configurations
Request Your Compliance Documentation Package
Full GMP documentation and the IQ/OQ/PQ validation package are available for all Prodigy systems. Contact our team to discuss your requirements and request the package for your application.