Aldevra | Good Manufacturing Practice Prep for Cannabis Edibles
This is a practical readiness tool, not legal advice. Adapt it to your state rules and any specific cGMP framework you follow (e.g., 21 CFR Part 117 for human food).
1. GMP FOUNDATION & QUALITY SYSTEM
Quality Management
☐ A designated Quality / Compliance lead is assigned with clear responsibility
☐ A written Quality Policy exists and is communicated to staff
☐ There is a defined organizational chart showing QA independence from production
☐ Change control process is documented (for formulas, processes, suppliers, equipment)
Document Control
☐ All SOPs, forms, and records have version control and approval signatures
☐ Only current versions are available in production areas
☐ Obsolete documents are removed from use and archived properly
☐ There is a master document list with latest revision dates
2. FACILITY, LAYOUT & FLOWS
Premises & Environment
☐ Facility is in good repair (no leaks, flaking paint, exposed insulation)
☐ Floors, walls, and ceilings are smooth, non-porous, and cleanable in production areas
☐ Adequate lighting is provided in all production and inspection areas
☐ Pest control program is documented with logs from a licensed provider
Product Flow & Segregation
☐ Layout supports logical flow: receiving → storage → processing → packaging → finished goods → shipping
☐ No backtracking where raw product crosses finished product paths
☐ Cannabis-active ingredients are segregated from non-infused ingredients
☐ Allergen ingredients (e.g., milk, nuts, soy, eggs) are segregated and clearly labeled
☐ Waste routes are defined and do not pass through clean/packaging areas
3. EQUIPMENT, MAINTENANCE & CALIBRATION
Equipment Design & Installation
☐ All food-contact equipment is food-grade and NSF or equivalent where appropriate
☐ Equipment is installed to allow cleaning underneath / behind (or sealed in place)
☐ Any wood or non-food-grade materials are eliminated in food-contact zones
Maintenance & Cleaning
☐ Preventive maintenance schedule exists for all key equipment
☐ Maintenance is logged (date, work performed, initials)
☐ Lubricants and chemicals used on or near equipment are food-grade where required
☐ Equipment breakdowns and repairs are documented and reviewed for product impact
Calibration
☐ Thermometers are calibrated on a defined schedule
☐ Scales and balances used for dosing, batching, and packaging are calibrated and labeled
☐ Calibration certificates or logs are kept on file
4. SANITATION & HYGIENE
Sanitation Program
☐ Written Master Sanitation Schedule exists (daily, weekly, monthly tasks)
☐ Cleaning procedures specify who, what, how, when, and with what chemicals
☐ Chemicals are approved for food use where appropriate and clearly labeled
☐ Cleaning/sanitation logs are completed and reviewed by supervision or QA
Employee Hygiene
☐ Handwashing sinks are accessible, stocked, and used
☐ Clear rules exist for handwashing, gloves, hair restraints, jewelry, and personal items
☐ Eating, drinking, vaping, and smoking are prohibited in production areas
☐ Employees are trained to report illness and are excluded when appropriate
5. SUPPLIERS, INGREDIENTS & RECEIVING
Supplier Approval
☐ Supplier approval program is documented (questionnaires, audits, certifications, COAs)
☐ Approved supplier list exists and is current
☐ Only approved suppliers are used for cannabis ingredients, food ingredients, and packaging
Receiving & Storage
☐ Incoming materials are inspected at receiving (condition, temperature if needed, documentation)
☐ Cannabis inputs (distillate, flower, kief, etc.) arrive with appropriate COAs per state rules
☐ Allergen-containing materials are clearly labeled and segregated
☐ Raw materials and packaging are stored off the floor and away from walls
☐ FIFO / FEFO (First In, First Out / First Expired, First Out) system is used
Status Identification
☐ Materials are labeled by status: Quarantine, Released, Rejected, Hold
☐ Rejected materials are clearly marked and physically segregated
6. FORMULAS, BATCH RECORDS & TRACEABILITY
Formulas & Specifications
☐ Each product has a standardized, approved formula with version control
☐ Specifications exist for finished products (appearance, texture, potency, packaging, label content)
Batch Records
☐ Batch records capture:
Ingredients and lot numbers
Weights and yields
Key time/temperature data
Equipment used
Operator initials and dates
☐ Batch records are completed in real time, not from memory
☐ Corrections follow GDP (Good Documentation Practice): single line-through, initial, date, reason
Traceability
☐ Each batch has a unique Batch ID / lot code
☐ There is forward and backward traceability:
From finished product → raw ingredients and cannabis inputs
From raw ingredients or cannabis lot → affected finished products
☐ Batch IDs are linked to Metrc/BioTrack or other seed-to-sale systems
7. POTENCY, LABELING & THC-SPECIFIC CONTROLS
Potency & Homogeneity
☐ There is a documented process to ensure THC is evenly distributed (mixing, homogenization)
☐ Sampling plans exist for in-process or finished product potency checks
☐ Batches are held pending COA where required by regulations
Labeling Controls
☐ All labels include required THC per serving, THC per package, and state-mandated warnings
☐ There is a label approval / sign-off process before new or revised labels go live
☐ Label storage is controlled; wrong labels are destroyed or clearly segregated
☐ Line clearance process is in place to prevent mixing labels or SKUs
Allergen & Special Claims
☐ All allergens are correctly declared (e.g., milk, soy, egg, wheat, nuts)
☐ Any “gluten-free,” “vegan,” “organic” claims are backed by documentation and SOPs
☐ Packaging is child-resistant and tamper-evident if required by state rules
8. PROCESS CONTROL, HACCP & DEVIATIONS
Critical Controls
☐ Critical control points are identified (e.g., cooking, cooling, potency, COA release)
☐ Critical limits for each CCP are clearly defined (time, temp, mg THC/serving, etc.)
☐ Monitoring procedures are written and understood by staff
Deviations & Nonconformances
☐ There is a form and process to document deviations (e.g., temp excursions, test failures)
☐ Root cause analysis is performed for significant deviations
☐ Corrective actions are defined and implemented, not just recorded
☐ Trending of deviations is done periodically to identify patterns
9. COMPLAINTS, RECALLS & INCIDENT RESPONSE
Complaints Handling
☐ A written procedure exists for consumer or customer complaints
☐ Complaints are logged, investigated, and categorized (quality vs safety vs regulatory)
☐ Outcomes and corrective actions are documented
Recall Readiness
☐ A written recall plan exists with defined roles and responsibilities
☐ Mock recalls are conducted at least annually
☐ Mock recall shows ability to identify affected lots and locate product quickly
Incident Management
☐ There is an escalation process for serious safety or regulatory incidents
☐ Communication templates exist (regulators, customers, internal stakeholders)
10. TRAINING, CULTURE & PERSONNEL
Training
☐ Job-specific training is documented for each role (production, QA, sanitation, maintenance, security)
☐ Training includes:
GMP basics
Personal hygiene
Allergen awareness
Cannabis-specific compliance (Metrc/BioTrack, waste rules, security)
☐ Training records show date, topic, trainer, attendee signatures
☐ Refresher training is scheduled (annual or as needed after incidents)
Culture & Accountability
☐ Supervisors model GMP behavior consistently
☐ Employees are encouraged to raise concerns without retaliation
☐ Quality and safety metrics are reviewed at management meetings
11. SECURITY & CANNABIS-SPECIFIC OVERLAY
While not classic GMP, regulators expect these in cannabis:
☐ 24/7 video surveillance covers critical GMP and cannabis handling areas
☐ Access to production, storage, and vaults is restricted and logged
☐ Cannabis waste is secured and documented until destruction
☐ GMP records and cannabis compliance records are aligned (no contradictions)
12. GMP READINESS SCORECARD
Quick snapshot before a big audit or new build:
GMP is where “looking clean” and “being compliant” finally match.
This checklist helps cannabis edibles manufacturers translate GMP expectations into concrete, day-to-day practices tied to real equipment, real batches, and real THC controls.
