EudraLex Volume 4 caps the Site Master File at 25 to 30 pages plus appendices. Nine chapters, eight appendices, and a stated preference for plans and drawings over prose. Most Canadian Licensed Producers write three times that on the first attempt.
A Site Master File is a controlled document summarising everything a site does under GMP: quality system, personnel, premises, equipment, production, quality control, distribution, and self inspections. For a Montreal producer supplying the German medical channel, it is the file an importer's Qualified Person reads before deciding whether to send an auditor. It is also the file a European inspectorate reads before scheduling one.
Most LPs draft it late, once a European partner has asked. That sequence costs months. Writing the file honestly exposes every gap in the quality system, and gaps close slowly. The nine chapters below are the same nine an auditor works through, in the same order.
What a Site Master File is, and who asks a Canadian LP for one
The Site Master File came out of PIC/S and was folded into Part III of the EU GMP guide, the informational part that sits beside the binding chapters. The requirement itself is referenced in Chapter 4 of Part I, on documentation. Part III carries the explanatory notes: what belongs in each chapter, what belongs in an appendix, and how long the whole thing should run.
Nothing in the Cannabis Regulations obliges a Canadian Licensed Producer to hold one. Health Canada inspects against Good Production Practices, and section 88 puts batch approval in the hands of the quality assurance person. There is no Canadian equivalent of the document. So it only appears when a buyer or a foreign authority asks.
Who actually asks for it
Three parties, usually in this order. An EU importer's Qualified Person asks during supplier qualification, before any audit date exists. The European authority that would inspect your site asks as part of an EU-GMP certification project sponsored by that importer. A large distributor running its own vendor assurance programme asks third, and will often take the file instead of a first-round questionnaire.
That third case is the practical argument for writing it early. A current file answers most of a supplier assessment in one document, in the format the assessor already reads. Qualification moves faster when the buyer does not have to translate your paperwork into theirs.
The nine chapters, and where cannabis sites lose marks
The chapter order is fixed. What varies is how much of it a cannabis site can answer without inventing something.
| Chapter | What it has to show | Where GPP-only sites fall short |
|---|---|---|
| 1. General information | Site addresses, 24 hour recall contact, site identifier, five years of inspections | A general phone line stands in for the recall contact |
| 2. Quality management system | Release procedure, supplier management, risk management, product quality reviews | No product quality review programme exists yet |
| 3. Personnel | Organisation chart, headcount by function | Chart shows names, not the quality reporting line |
| 4. Premises and equipment | Plans, room classification, pressure differentials, HVAC, water systems | Drying and trim rooms carry no defined classification |
| 5. Documentation | Document system, off site archiving, retrieval times | Records split across paper and several systems |
| 6. Production | Product types, campaign working, process validation policy, rework policy | Drying and curing treated as craft, not validated process |
| 7. Quality control | Physical, chemical, microbiological and biological testing done on site | Testing outsourced, contract lab barely described |
| 8. Distribution and recalls | Customer eligibility checks, transit conditions, traceability, diversion controls | Usually the strongest chapter a Canadian LP writes |
| 9. Self inspections | Selection criteria, arrangements, follow up | Programme exists on paper, follow up undocumented |
Chapter 8 is the one Canadian producers tend to win on. Recipient eligibility checks, transit conditions, and batch traceability are already built into how a Licensed Producer operates, so the chapter writes itself from existing records.
Chapter 2 is where reviewers spend their time
Four things get read closely in the quality management system chapter:
- the education and work experience of whoever certifies batches
- the batch certification and release procedure, described end to end
- the external audit programme standing behind your suppliers
- the methodology used for product quality reviews
A site that has never completed a product quality review cannot describe the method. The absence shows up in one sentence. Fix the programme first, then write the paragraph.
Chapter 1 asks for every GMP inspection of the site in the last five years, with dates and the authority that carried it out. A Canadian LP lists Health Canada inspections, which is correct and expected. What matters is what you claim they prove. GPP inspection history is not an EU-GMP record, and dressing it up as one damages the rest of the file.
The premises chapter, written honestly
If your drying and trim rooms have no defined classification, say so. A file claiming graded cleanroom areas you cannot support with qualification data turns a routine desk review into a for-cause conversation, and that wound is self-inflicted. Describe the design basis you have: filtration, air change rates where they are measured, the pressure regime between adjoining rooms, and the environmental monitoring behind it. Auditors forgive a modest facility described accurately. They do not forgive the reverse.
The eight appendices, and the D-U-N-S requirement
Appendices carry the evidence. Each one can hold its own effective date, so they update on separate cycles from the main text.
- Appendix 1: copy of the valid manufacturing authorisation
- Appendix 2: dosage forms made on site, with active ingredient names
- Appendix 3: copy of the current GMP certificate
- Appendix 4: contract manufacturers and laboratories, with supply chain flow charts
- Appendix 5: organisation charts
- Appendix 6: production area layouts, with material and personnel flows
- Appendix 7: schematic drawings of the water systems
- Appendix 8: list of major production and laboratory equipment
Two of those stop Canadian producers cold. Canada issues no European style manufacturing authorisation for cannabis, and the explanatory notes anticipate exactly that: where the competent authority does not issue one, the file states it. Your cannabis licence goes in its place, with the authorised activities described plainly. Appendix 3 repeats the problem one step further, because a site not yet certified has no EU GMP certificate. The honest entry is a statement of that fact, cross referenced to the inspection history in Chapter 1.
The D-U-N-S requirement catches people out
A Site Master File submitted to an EU or EEA authority for a manufacturing site outside the EU and EEA has to carry a D-U-N-S number for that site. Montreal is outside the EU. The number is free to request. It attaches to one legal entity at one civic address, and it has to match the entity named on your licence and on your export paperwork. Groups that hold the licence in one company and the lease in another discover the mismatch late, usually the week the file is due.
Appendix 4 rewards early work. Most Canadian LPs send potency and contaminant testing to an external laboratory accredited to ISO/IEC 17025. That makes the laboratory a documented link in the supply chain, with a flow chart, a quality agreement, and defined responsibilities behind it. The accreditation scope importers verify belongs in the file as well, not just the lab's name. Draw the flow chart before an auditor asks, because drawing it tends to surface a step nobody owns.
The four-point readiness check before an audit
The file belongs to the quality system, not to marketing. It carries an edition number, an effective date, and a review date, and it gets reviewed on a schedule like any other controlled document. Four checks catch most of what goes wrong before it leaves the building. Call it the Four-Point Site Master File Readiness Check.
- Version control. Edition number, effective date, review date, and a change history showing the file has been reviewed since it was first written.
- Cross references. Every SOP number quoted resolves to a current, approved document. Dead references sink credibility in a desk review and lead straight to data integrity questions.
- Appendices against reality. The organisation chart matches current staffing, the equipment list matches the floor, the laboratory list matches whoever tested your last export batch.
- Open commitments. Everything promised to an inspector, in Canada or abroad, with the status of each. Auditors check whether you closed what you said you would close.
Page count is the final discipline. The limit exists because an inspector wants a map, not a manual, and a file three times the recommended length signals an author who could not tell the difference. Cut narrative, add a drawing, move the detail into an appendix where it can be revised on its own cycle.
AlphaLeaf is a Health Canada Licensed Producer in Montreal, growing indoor, hand-trimmed flower from refined genetics. Our batch testing records, full traceability, and export authorisation under the Cannabis Act are documented in the structure European importers and their Qualified Persons expect before they commit to an audit.
Write the file before a buyer asks for it. The exercise finds the same gaps an auditor would find, on your calendar rather than theirs. If you are qualifying a Canadian supplier for a European or Australian programme and want to see how our documentation is organised, talk to our team. Bring your questionnaire. We will answer it from the file.
Frequently Asked Questions
What is a Site Master File in cannabis manufacturing?
A Site Master File is a controlled document summarising a manufacturing site's GMP activities. It runs to nine chapters: general information, quality management system, personnel, premises and equipment, documentation, production, quality control, distribution and recalls, and self inspections. For a Canadian cannabis Licensed Producer, it is the document an EU importer's Qualified Person or a European inspectorate reads before scheduling an audit.
Does Health Canada require a Licensed Producer to have a Site Master File?
No. The Cannabis Regulations contain no Site Master File requirement. Health Canada inspects Licensed Producers against Good Production Practices, and section 88 places batch approval with the quality assurance person. The Site Master File is a European GMP expectation, so it becomes relevant when a Canadian LP supplies an EU importer or pursues EU-GMP certification.
How long should a cannabis Site Master File be?
EudraLex Volume 4 recommends that the file not exceed 25 to 30 A4 pages plus appendices, and prefers simple plans, outline drawings and schematic layouts over long narrative. Detail that does not fit belongs in an appendix, which can carry its own effective date and be updated independently of the main text.
What are the nine chapters of a Site Master File?
General information on the manufacturer, quality management system, personnel, premises and equipment, documentation, production, quality control, distribution and complaints and recalls, and self inspections. Eight appendices sit behind them, covering the manufacturing authorisation, product list, GMP certificate, contract laboratories, organisation charts, area layouts, water system drawings and major equipment.
Does a Canadian cannabis site need a D-U-N-S number for its Site Master File?
Yes, where the file goes to an EU or EEA authority. The explanatory notes require a D-U-N-S reference for manufacturing sites located outside the EU and EEA, which covers every Canadian facility. The number must match the legal entity and civic address shown on the cannabis licence and on the export documentation, or the submission raises questions before it is read.
How often should a Site Master File be reviewed?
The file is part of the quality management system and is kept current, with an edition number, an effective date and a stated review date. Common practice is a review at least once a year. An immediate update follows any change that alters the site, such as new equipment, a new building, a change of Qualified Person or quality assurance person, or a new contract laboratory.
