Cannabis Production Batch Record Review and Quality Release Checklist
This cannabis production batch record review and quality release checklist ensures that every production batch is reviewed against GMP batch record standards and passing COAs before product is approved for sale. Quality release authority creates a documented check against releasing non-compliant product — one of the core principles of pharmaceutical-adapted GMP for cannabis manufacturing.
- Industry: Cannabis
- Frequency: Per Production Batch
- Estimated Time: 30-45 minutes
- Role: Quality Manager / Quality Control Lead
- Total Items: 30
- Compliance: GMP Batch Record Requirements for Cannabis Manufacturing, State Cannabis Quality Control Release Requirements, METRC Batch Reconciliation Requirements, State Cannabis COA Release Criteria, FDA 21 CFR Part 211 Batch Record Principles (Adapted)
Batch Record Completeness
Record documentation review.
- Batch ID consistent throughout all batch record documents?
- All input materials documented with lot numbers, quantities, and COAs?
- All critical process parameters recorded throughout production?
- All batch record entries initialed by performing operator?
- No blank, incomplete, or illegible entries in batch record?
COA Review and Release Criteria
Testing result evaluation.
- Passing COA received from state-licensed testing lab for this batch?
- COA sample ID traceable to this batch — no COA from different batch?
- All required testing panels show PASS status?
- No analyte results exceeding state limits — even marginally?
- Potency results within expected range for product type and genetics?
METRC Batch Reconciliation
State tracking system check.
- METRC production batch output weight matches batch record yield?
- All waste from production batch recorded in METRC?
- METRC product packages created from batch with correct product name and category?
- Package label information matches METRC entry?
- METRC batch finalized after quality release authorization?
Deviation Review
Non-conformance assessment.
- Any deviations from SOP documented during this batch?
- Deviation impact on product quality assessed and documented?
- Deviation approved by quality authority before batch release?
- Corrective action initiated for any deviation to prevent recurrence?
- No unresolved major deviations that would prevent batch release?
Label and Packaging Review
Compliance packaging check.
- Product label reviewed and approved before printing?
- Potency from COA reflected accurately on product label?
- Packaging certified child-resistant per CPSC 16 CFR 1700?
- All state-required warnings and symbols on label?
- Batch/lot number and production date on label as required?
Quality Release Authorization
Final release decision.
- Batch APPROVED for release — all checks passed?
- Quality release authorization signed by authorized quality person?
- Complete batch record filed in secure, organized batch record archive?
- Product package available for sale in METRC after quality release?
- Batch Review Notes
Related Quality Management Checklists
- Cannabis Product Recall Procedure and Traceability Checklist
- Cannabis Product Recall Procedure and Traceability Checklist
- METRC Cannabis Track-and-Trace System Compliance Checklist
- Aviation SMS Internal Audit Checklist
- ISO 9001:2015 Internal Audit Checklist - India
- Cannabis Facility State Regulatory Inspection Readiness Checklist
Related Quality Assurance Checklists
Why Use This Cannabis Production Batch Record Review and Quality Release Checklist?
This cannabis production batch record review and quality release checklist helps cannabis teams maintain compliance and operational excellence. Designed for quality manager / quality control lead professionals, this checklist covers 30 critical inspection points across 6 sections. Recommended frequency: per production batch.
Ensures compliance with GMP Batch Record Requirements for Cannabis Manufacturing, State Cannabis Quality Control Release Requirements, METRC Batch Reconciliation Requirements, State Cannabis COA Release Criteria, FDA 21 CFR Part 211 Batch Record Principles (Adapted). Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Cannabis Production Batch Record Review and Quality Release Checklist cover?
This checklist covers 30 inspection items across 6 sections: Batch Record Completeness, COA Review and Release Criteria, METRC Batch Reconciliation, Deviation Review, Label and Packaging Review, Quality Release Authorization. It is designed for cannabis operations and compliance.
How often should this checklist be completed?
This checklist should be completed per production batch. Each completion takes approximately 30-45 minutes.
Who should use this Cannabis Production Batch Record Review and Quality Release Checklist?
This checklist is designed for Quality Manager / Quality Control Lead professionals in the cannabis industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.