01 · SOPs
Master SOP library
Form DCC-LIC-019 SOPs for receiving, manufacturing, packaging, storage, sanitation, and recall — written to your actual process.
Form DCC-LIC-019 SOPs, master batch records, change control, deviation tracking, CAPA frameworks, and recall procedures — written to CCR 17200 and translated for operators familiar with 21 CFR Part 111.
Most cannabis manufacturers fail DCC inspection not on the floor but in the document vault — PQPs missing or generic, MMPs that describe a formulation the kitchen no longer runs, BPRs back-filled at end-of-shift with handwriting that gives the practice away, allergen statements absent on infused products, closed-loop PE certification stale after a material modification. The DCC publishes specific checklists for the Product Quality Plan, Master Manufacturing Protocol, Batch Production Record, closed-loop extraction system, and allergen-control program; the operators who pass inspection are the ones whose documents are written to those checklists rather than to a template purchased once and never updated.
Owning the quality system means four concrete things. We draft the Product Quality Plan per product under CCR 17303 (one PQP per product, identifying adulteration, misbranding, lab-failure, and QA-failure risks at every step), the Master Manufacturing Protocol per formulation (ingredients, equipment, process parameters, QC checks, yield reconciliation), and the Batch Production Record under CCR 17304 (per-batch contemporaneous evidence with operator signoff, in-process checks, deviation references, and QC release disposition). We stand up the CAPA, deviation, and change-control workflows with named approvers, escalation paths, and seven-year retention aligned to CCR 15037. We qualify the equipment — IQ, OQ, PQ for every piece of processing gear, plus PE certification and re-certification for any closed-loop extraction system — so performance is documented against specification before the first commercial batch. And we build the allergen-control program for every edible and infused product against the DCC allergen guidance and the FDA Big 9.
What you keep: product formulation decisions, equipment selection, capital plan for facility buildout, and ongoing manufacturing leadership. Where the work crosses into privileged engineering (PE-stamped facility plans for Type 7 volatile extraction, closed-loop certification under CCR 17200–17210, OSHA PSM process hazard analysis above solvent thresholds) we coordinate directly with your PE and the local fire authority but we do not replace them. Where it crosses into privileged legal analysis (enforcement response, recall communications under BPC 26131, product-liability exposure) we work under counsel’s direction. The engagement letter draws both lines before fieldwork begins.
Figures from the DCC Feb 5 2025 enforcement recap, CCR Title 4 Division 19 (§§ 17200–17210 manufacturing core, § 17408 COA format, § 15037 retention), and federal 21 CFR Part 111.
Five elements every batch-record SOP needs to survive a DCC inspection — and to hold up if you ever cross into federal GMP territory.
6.1 Input Material Verification. Crude oil received per BR-MFG-0114-01 must carry a valid Certificate of Analysis from the source licensee bearing METRC tag 1A4060300...
6.2 Batch Identity. Each run assigned a unique Batch Lot Number (format: YYYYDDD-###-R), recorded at intake, locked before purification starts.
6.3 Deviation Trigger. Any observed value outside the range specified in Appendix A triggers deviation workflow DEV-MFG-002 and halts processing until a quality engineer signs off.
6.4 Record Retention. Batch records retained for 7 years per CCR 15037, searchable by batch number and calendar week.
Every batch ties to a verified COA and METRC tag. No assumed provenance — the input is documented before processing begins.
Batch number assigned at intake and frozen before any purification occurs — this is the single record DCC will ask you to produce in any audit.
Not “consult supervisor.” A named procedure (DEV-MFG-002) with a form, an approver, and a disposition code. Auditable from day one.
7-year retention under CCR 15037, organized so an investigator can locate a 2019 batch in under 15 minutes.
Every figure below is sourced to the DCC, the CCR, or the governing statute. Defensible batch records and qualified equipment keep recalls targeted, not catastrophic — and the four categories below are where unprepared operators break.
Product destruction, customer refunds, COA reprocessing, METRC reconciliation. Mandatory recalls under CCR 17408 + BPC 26131 run 2–4× more expensive — and scope blows wide when batch genealogy can’t isolate the affected lots. (CCR 17408)
When a batch fails downstream testing, root-cause investigation cannot reconstruct what actually happened at extraction, infusion, or packaging if the SOP describes a process that was never run. Template SOPs are the single most common recall amplifier. (CCR 17303–17304)
Blank in-process check fields, undocumented deviations, unsigned lines: each gap widens the recall scope because unsigned records cannot exclude affected product. Good BPRs isolate; bad BPRs broadcast. (CCR 17304)
Type 7 extraction facilities running without current IQ/OQ/PQ documentation: a single equipment-related failure becomes a facility-wide release hold because no individual batch can be cleared without equipment qualification evidence. (CCR 17205–17207)
Our job is to never put you in any of these four categories. Every run documented to CCR 17304 standard. Every deviation investigated and CAPA-closed. Every piece of processing equipment qualified and revalidated on schedule. Recalls targeted in an afternoon, not a quarter.
Each system is an independently auditable deliverable, cited to a specific CCR, CFR, or ISO clause. Scroll for all ten.
Form DCC-LIC-019 SOPs for receiving, manufacturing, packaging, storage, sanitation, and recall — written to your actual process.
Format that binds input COA, METRC tags, process parameters, in-process samples, yield, and disposition — auditable in one page per batch.
Written change-request workflow for any SOP, equipment, supplier, or formula modification — with approval gate and revalidation trigger.
Deviation form, investigation template, CAPA trigger, and impact-assessment matrix — with escalation to quality engineer and CPO.
CCR 17408 and BPC 26131 recall procedure, complete with notification templates, METRC hold protocol, and annual mock recall drill.
Cleaning and sanitation SOP, environmental monitoring program, allergen-control plan (for kitchens), and corrective-action triggers.
Role-based training matrix, qualification curricula, competency assessments, and retraining triggers tied to deviation and change-control events.
Supplier approval questionnaire, COA audit protocol, incoming material specifications, and quarantine procedure for non-conforming lots.
IQ/OQ/PQ documentation for closed-loop systems, homogeneity validation for infusions, and annual revalidation schedules.
Top-level document mapping every SOP, every record, every regulation — the single binder you hand DCC, FDA, or a diligence team.
A manufacturing quality system is operational infrastructure, not a binder of procedures. The point is the batch records that hold up under DCC inspection, the deviation trail that survives diligence review, and the recall capability that keeps a targeted event from becoming a facility-wide catastrophe. Here is the shape of that posture once the build completes.
Every SOP cites the regulation it implements. Every Batch Production Record format traces to CCR 17304. Every CAPA template maps to the BPC 26031(b) mitigation-factor framework so that if the record ever needs to defend an enforcement action, the structure is already in place. Nothing opinion-based, nothing inferred.
California cannabis manufacturing sits on top of a four-layer authority stack: state statute (Business & Professions Code Division 10, with manufacturing product standards at BPC 26101 and recall authority at BPC 26131), state regulation (California Code of Regulations Title 4 Division 19, with the CCR 17000 series covering manufacturing sanitation at 17302, MMP and PQP requirements at 17303, batch records at 17304, labeling release at 17305, and record retention at 17306), federal GMP adjacency (21 CFR Part 111 for dietary supplements and 21 CFR Part 210/211 for drugs, increasingly relevant as interstate commerce moves toward federal permissibility), and process-safety authority (NFPA 1 fire code for Type 7 extraction and OSHA PSM for facilities above solvent thresholds). The QMS tracks all four.
Any Type 6 (non-volatile), Type 7 (volatile), Type N (infusion-only), Type P (packaging-only), or Type S (shared-use tenant) manufacturer is required by CCR 17303 and 17304 to maintain a Product Quality Plan, Master Manufacturing Protocol, and Batch Production Record per the DCC documentation triangle. Operators planning interstate commerce when federal rules permit will need federal GMP-adjacent systems aligned to 21 CFR Part 111. Most diligence processes for institutional investment now require a quality manual as a precondition — no QMS, no deal.
Most cannabis SOPs are generic templates purchased once and never updated, and they fail DCC review because the description does not match the floor. We rewrite each SOP to your actual process — your solvent inventory, your equipment, your floor layout, your supplier — and tie each unit operation back to the PQP risks and the MMP instructions per CCR 17303. Every SOP gets a batch-record format under CCR 17304 and a revision-control header so updates are auditable, dated, and approver-stamped. The result holds up under inspection because root-cause investigation can actually reconstruct what happened.
Typical Type 7 volatile-extraction operator: 10–14 weeks of active work across a 90-day engagement. Type 6 non-volatile and Type N infusion-only operations run 6–10 weeks; multi-product Type S shared-use facilities and large kitchens run 12–20 weeks because each tenant brings its own PQP/MMP/BPR set. We publish a weekly delivery cadence with two-week document drafts so you see progress live and can pivot if DCC inspection becomes imminent.
The framework translates directly to 21 CFR Part 111 (dietary-supplement GMP) and is adjacent to 21 CFR Part 210/211 (drug GMP), which is the upper bound of QMS rigor. The CCR 17000-series sanitation, PQP/MMP/BPR documentation, training, and equipment qualification map cleanly onto Part 111 subparts so the gap is small the day federal rules permit interstate commerce. Clients who have gone through institutional diligence with this QMS have come through without material findings, because diligence reviewers default to Part 111 as the standard and our QMS reaches it.
Both. We draft the first version end-to-end — PQPs, MMPs, BPR templates, SOPs, CAPA procedure, training records, equipment qualification packages — then train your QA lead and manufacturing supervisors on execution, contemporaneous BPR completion, and deviation reporting. Hand-off includes a maintenance playbook covering the quarterly document review, the annual mock-recall drill, the equipment re-qualification schedule, and the CCR rulemaking-monitoring cadence. Optional quarterly retainer at $4K–$8K covers the change-control queue, the annual revalidation cycle, and continuous CCR 17000-series and DCC-checklist update tracking.
Cannabis cannot be cGMP-certified in the traditional federal sense today because of Schedule I scheduling, but we build to cGMP expectations under 21 CFR Part 111 so that when federal rules change the gap is small. Several state-level voluntary cGMP programs and third-party certification schemes (such as Patient-Focused Certification and Clean Green) exist as interim signals; we map the QMS to these where a client wants the seal. The deeper value is operational — a Part 111-aligned QMS produces fewer deviations, tighter recall scope, and the diligence posture institutional capital expects.
We do not replace your operational systems — we build the paper-and-record architecture that sits on top of them. Batch-record format exports tie to METRC package IDs and your ERP item codes; deviation log integration routes events from the floor into the CAPA ticketing system; document control sits in a versioned vault with controlled access. Works with most cannabis-market ERPs (Flowhub, Dutchie, Distru) and with METRC processing-job records under the manufacturing track-and-trace framework so the BPR ties to the package and the package ties to the COA.
The first deliverable on day one is the gap analysis — what is defensible, what is not, and the triage order against the DCC PQP, MMP, BPR, closed-loop extraction, and allergen checklists. If inspection is imminent we pivot the sequence and prioritize inspection-readiness documentation: BPRs cleaned up for in-process batches, training records current, surveillance footage retention verified, the closed-loop PE certification on hand. The deeper QMS build continues behind it so the inspection-ready posture becomes the steady-state posture.
Yes. Recall SOP under CCR 17408 and BPC 26131, notification templates for retailer and consumer notice, METRC hold protocol placeable within 24 hours, destruction documentation, DCC reporting workflow, and an annual mock-recall drill with written report demonstrating recall capability before the regulator tests it. Recall capability is both a DCC requirement and a diligence marker; the average voluntary recall costs $320K, mandatory recalls run 2–4× that, and the difference between targeted and broadcast scope is whether batch genealogy in the BPR can isolate affected lots.
Type 6 non-volatile manufacturer: $38K–$65K for a full QMS build. Type 7 volatile-solvent extraction: $65K–$120K depending on facility complexity, PE coordination scope, and OSHA PSM applicability. Multi-product kitchens and Type S shared-use hosts: $85K+ because each tenant brings its own PQP/MMP/BPR set. Retainer maintenance is $4K–$8K per quarter; everything is fixed fee against a written scope and payable in milestones tied to deliverables.
One 30-minute scoping call: we survey your license type, production scope, and current documentation, then scope a fixed-fee engagement.