The current text of EU-GMP Chapter 2 came into operation on 16 February 2014. It is the chapter European inspectors use to judge the people behind a batch. In 2026, it also shapes how importers read a Canadian Licensed Producer's organisation chart, training files and gowning rules.
EU-GMP Chapter 2 personnel requirements cover four areas. You need named senior roles with written job descriptions, independent heads of Production and Quality Control, GMP training with assessed effectiveness, and a strict hygiene program. Health Canada rules name some of these roles. They don't require most of the structure around them.
What EU-GMP Chapter 2 requires from a cannabis LP
Chapter 2 opens with a plain principle: correct manufacture relies on people, so a manufacturer needs enough qualified staff and clearly recorded individual responsibilities. Medical cannabis flower entering the EU is handled under EU-GMP rules for medicinal products. That puts your people under the same scrutiny as a tablet manufacturer's.
The organisation chart and job descriptions
Paragraph 2.2 requires an organisation chart. It must show the heads of Production and Quality Control, any Head of Quality Assurance, and where the Qualified Person sits. Paragraph 2.3 adds written job descriptions, named deputies and a hard test: no gaps or unexplained overlaps in GMP responsibilities.
Paragraph 2.4 places ultimate responsibility on senior management. They set the quality policy and take part in management review. Expect an auditor to ask who chaired the last management review and what it decided.
Senior roles and the independence rule
Paragraph 2.5 asks senior management to appoint a head of Production and a head of Quality Control, normally full-time. The two must be independent from each other. Paragraphs 2.7 and 2.8 list their duties. Production approves production instructions and makes sure records are signed off. Quality Control approves or rejects materials and finished product, and it approves specifications and test methods.
Where the Qualified Person sits
Canada is a third country under EU rules. For its product, paragraph 2.6 requires a Qualified Person in an EU member state to certify each batch after testing there. That QP usually works for your importer, not for you. Our guide to EU QP batch release for Canadian cannabis LPs covers that hand-off in detail. Your Chapter 2 file has to show the QP exactly where their certification depends on your people, because they will check.
How Chapter 2 compares with the Cannabis Regulations
The Cannabis Regulations name individuals by licence type. Section 37 requires a responsible person with authority to bind the licence holder. A head of security is required under section 38, a master grower under section 12 for cultivation licences, and a quality assurance person under section 19 for processing licences.
The sanitation program required by section 87 must cover the health and hygienic behaviour of personnel. Hand cleaning stations fall under section 87.1. Those two provisions overlap with the Chapter 2 hygiene rules. Most of the other requirements have no Canadian equivalent, as the table shows.
| Requirement | EU-GMP Chapter 2 | Cannabis Regulations |
|---|---|---|
| Named quality role | Heads of Production and QC, plus EU QP | Quality assurance person (s. 19) |
| Production and QC independence | Required (2.5) | No equivalent requirement |
| Organisation chart | Required (2.2) | No equivalent provision |
| Written job descriptions | Required, with deputies (2.3) | No equivalent provision |
| Training effectiveness | Periodically assessed (2.11) | No equivalent provision |
| Medical examination at hire | Expected (2.16) | No equivalent provision |
| Personnel hygiene | Detailed program (2.15 to 2.21) | Sanitation program (s. 87) |
| Consultant records | Required (2.23) | No equivalent provision |
The quality assurance person is the closest Canadian match to a head of Quality Control. Our breakdown of cannabis quality assurance person requirements explains that role. A QAP who also reports to the head of cultivation fails the independence test the moment an EU auditor draws the reporting lines.
If one person runs cultivation and approves the batches that cultivation produces, you are not ready to supply the EU. Fix the organisation chart before you book the audit.
Training and hygiene on a hand-trim line
Paragraph 2.10 extends training to everyone whose duties take them into production, storage or laboratory areas, including maintenance and cleaning staff. Paragraph 2.11 asks for training programs approved by the head of Production or the head of Quality Control, kept records, and a periodic check that the training actually works.
That last clause needs more than attendance records. A signed sheet proves someone sat in the room. It doesn't prove they can run a line clearance or spot a mould-affected bud, and paragraph 2.11 asks for exactly that kind of evidence.
The hygiene rules that touch hand-trimmed flower
Paragraphs 2.15 to 2.21 set the hygiene baseline. Staff get a medical examination on recruitment, people with infectious disease or open lesions on exposed skin stay off production, and protective garments match the operation. Eating, drinking, smoking and personal medication are banned from production and storage areas.
Paragraph 2.20 matters most for premium flower: avoid direct contact between operators' hands and exposed product. Hand-trimming is compatible with that rule when trimmers work gloved, change gloves at defined points and keep shears inside the sanitation program. The comparison of hand-trimmed vs machine-trimmed cannabis for export covers the quality case for keeping hands on the flower.
An auditor will ask for proof that every trimmer followed the glove-change rule on every batch. Record glove changes in the batch record so that proof already exists when the question comes.
The 5-step Chapter 2 readiness check for Canadian LPs
Use this sequence before an importer audit or a remote documentation review. It turns Chapter 2 into a file an auditor can read in one sitting.
1. Draw the organisation chart
Show Production, Quality Control, any Quality Assurance function and the reporting line to senior management. Mark where your importer's EU QP relies on your release data.
2. Write job descriptions with deputies
Give every GMP-relevant role a signed description and a named deputy. Then check the set for gaps and overlaps, especially between cultivation, post-harvest and QA.
3. Build a role-based training matrix
List required training per role, including cleaning and maintenance staff. Have the head of Production or Quality Control approve it, and add a practical assessment for each critical task.
4. Align hygiene with your sanitation program
Fold medical screening at hire, illness reporting, gowning and glove changes into the program you already keep under section 87. Add the food and medication ban too. One document is easier to defend than two.
5. Log every consultant
Paragraph 2.23 asks for each consultant's name, address, qualifications and type of service. Contract laboratories and service providers sit under a different chapter, covered in our guide to EU-GMP Chapter 7 outsourced activities.
Run this check once a year as part of your EU-GMP Chapter 9 self-inspection, so personnel findings surface internally before an importer finds them.
AlphaLeaf is a Health Canada Licensed Producer working from an indoor facility in Montreal, producing hand-trimmed flower from refined genetics. Every batch carries ISO-certified test data and full traceability. With export authorisation under the Cannabis Act, we give EU importers and their Qualified Persons the documentation trail their audits expect.
Want to see how our personnel and training records hold up against Chapter 2? Contact the AlphaLeaf team to request our supplier documentation. Ask for the training matrix first.
Frequently Asked Questions
What does EU-GMP Chapter 2 cover?
EU-GMP Chapter 2 sets the personnel rules for medicinal product manufacturers. It covers senior responsibilities, the heads of Production and Quality Control, the Qualified Person, training, personnel hygiene and consultants. For Canadian cannabis LPs supplying the EU medical channel, it defines what importers expect to see in your organisation chart and training records.
Does Health Canada require independent heads of production and quality control?
No. The Cannabis Regulations require named individuals such as a responsible person, a head of security, a master grower and, for processing licences, a quality assurance person. They do not set an independence rule like paragraph 2.5 of EU-GMP Chapter 2, so EU-bound LPs need to build that separation themselves.
Is hand-trimmed cannabis compatible with EU-GMP hygiene rules?
Yes. Paragraph 2.20 asks manufacturers to avoid direct contact between operators' hands and exposed product. Trimmers working gloved, with defined glove-change points and shears covered by the sanitation program, meet that expectation. The evidence has to be recorded batch by batch.
Do cannabis LP employees need a medical examination under EU-GMP?
Chapter 2 expects all personnel to receive a medical examination on recruitment, with further checks when needed for the work or personal health. It also expects instructions that make sure health conditions relevant to product quality are reported to the manufacturer.
Who approves the training program under EU-GMP Chapter 2?
Paragraph 2.11 says training programs should be approved by the head of Production or the head of Quality Control, as appropriate. Training records must be kept, and the practical effectiveness of continuing training should be assessed periodically.
Does EU-GMP Chapter 2 apply to cannabis consultants?
Yes. Paragraph 2.23 says consultants need adequate education, training and experience for the advice they give. The manufacturer should keep records of each consultant's name, address, qualifications and type of service provided.
