Dispensary Operating Manual Checklist

21 CFR 111 compliance map — QA642 final project

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Rubric deliverables required

CFR anchorDeliverableNote
—Dispensary name and locationBrief description + target market
—Local / state / federal law sectionName the codes; don't just link FDA
111.8–14Employee roles + onboarding training by roleUse week 11 prompt as minimum role list
111.8–14One fully written health & hygiene SOP exampleE.g. Handwashing SOP — version no. + revision date required
111.25–35Facility and equipment maintenance / calibration log list—
111.25–35One fully written maintenance or calibration log exampleVersion + revision date required
111.55–95SOP list for compounding and dispensing—
111.205–210Master Manufacturing Record (MMR) requiredFormalized recipe = controlled document
111.255–260Batch Production Record (BPR) requiredLog of actual steps + measurements per run
111.55–95One fully written compounding procedure exampleVersion + revision date required
—Professional / industry organization listShort narrative justifying startup resources spent on each
—Supplier assessment and review policyDistinct from material disposition — see AHPA Section 10 tool
—One intake and quality check log (cut & sifted herbs) exampleSimulated delivery scenario
111.553–570Adverse event reporting policyInclude recall procedures for compounded product
—Executive summary: herbal → THC dispensary transitionMust explicitly state where frameworks converge and where they don't

21 CFR 111 SOP coverage — full table of contents

Every row below belongs in your table of contents. Only rubric-flagged items need to be fully written. Each document requires a version number and revision date.

CFR sectionSOP / document titleType
111.8–14Handwashing SOPPersonnel
111.8–14Presenteeism SOPPersonnel
111.8–14Personal hygiene SOPPersonnel
111.15–23Garbage collection, storage, removal SOPSanitation
111.15–23Sewage cleaning and sanitation SOPSanitation
111.15–23Pest control — daily in-house procedureSanitation
111.15–23Pest control service contractSanitation
111.15–23Water supply testing SOPSanitation
111.25–35Warehouse equipment: cleaning, sanitation, maintenance, storage, software backupsEquipment
111.25–35Dispensary equipment: cleaning, sanitation, maintenance, storage, software backupsEquipment
111.25–35Utensils (warehouse and dispensary): cleaning, sanitation, storageEquipment
111.55–95Raw material data sheet (organoleptic, macroscopic, microscopic, chemical)Production system
111.55–95Certificate of Analysis retention procedure (supplier)Production system
111.55–95Reserve sample procedureProduction system
111.55–95Material disposition review processProduction system
111.55–95Supply chain logProduction system
111.55–95In-process quality control logProduction system
111.55–95In-process adjustment procedureProduction system
111.55–95Packaging specificationsProduction system
111.55–95Labeling specificationsProduction system
111.103–140Component material disposition reviewQuality control
111.103–140In-process adjustment dispositionQuality control
111.103–140Returned products disposition review processQuality control
111.153–180Disposition of contaminated materials procedurePackaging & labeling
111.153–180Completed product data sheets retentionPackaging & labeling
111.153–180Disposition of returned materials procedurePackaging & labeling
111.153–180Master and batch LOT recordsPackaging & labeling
111.153–180Labeling requirements checklist (identity, net qty, nutrition, ingredients, manufacturer)Packaging & labeling
111.205–210Master Manufacturing Record formMMR
111.255–260Batch Production Record formBPR
111.303–325Laboratory data sheet retention (electronic or paper)Lab operations
111.353–375Manufacturing operations: sanitation, contamination, rejectionManufacturing
111.403–430Packaging procedurePkg & labeling ops
111.403–430Labeling procedurePkg & labeling ops
111.453–475Completed batch records (distribution)Holding & distribution
111.453–475Distribution recordsHolding & distribution
111.453–475Holding recordsHolding & distribution
111.503–535Returned product procedureReturned product
111.503–535Returned product formReturned product
111.503–535Returned product dispositionReturned product
111.503–535Returned product disposition formReturned product
111.553–570Customer complaint formComplaints
111.553–570Complaint disposition formComplaints
111.605–610Record retention schedule and document control policyRecord keeping

Document control — applies to every document above

ElementRequirement
Version numberOn every SOP, log, and form
Revision dateOn every SOP, log, and form
Discrete documentsEach SOP is a standalone file, not a section of a narrative
Retention scheduleDefined per 111.605–610