EU-GMP batch record software for medical cannabis

What EU-GMP asks of a batch record

The content of a batch record is set by Chapter 4 of EU-GMP Part I (Documentation). Section 4.20 requires a batch processing record for each batch, based on the currently approved manufacturing formula and processing instructions. It must contain:

• the name and batch number of the product;
• dates and times of the start, of significant intermediate stages and of completion;
• who performed each significant step and, where appropriate, who checked it;
• the batch number and quantity of each starting material actually weighed;
• the processing operations and events, and the major equipment used;
• the in-process controls, who carried them out and the results;
• the yield at the relevant stages of manufacture;
• notes on special problems, with signed authorisation for any deviation from the instructions;
• approval by the person responsible for the processing operations.

Section 4.21 adds a batch packaging record with checks for identity and conformity, the packaging line used, and a reconciliation of printed packaging materials and bulk product issued, used, destroyed or returned. The rules on how records are made apply to both: records are completed at the time each action is taken (4.8), any alteration is signed and dated and leaves the original readable (4.9), and for electronic records the regulated user defines which data are raw data. Batch documentation is kept for one year after the batch expires or at least five years after QP certification, whichever is longer (4.11).

For medical cannabis, EU-GMP Annex 7 on herbal medicinal products adds what the processing instructions must describe: operations such as cleaning, drying, crushing and sifting, with drying times and temperatures and the methods used to control cut size, and written records showing that each container of herbal substance was examined for foreign matter or signs of decay.

From batch record to QP certification

Article 51 of Directive 2001/83/EC makes the Qualified Person responsible for certifying that each batch was manufactured and checked in line with the law and its marketing authorisation. EU-GMP Annex 16 sets out how. Before certifying, the QP must be assured, among other things, that all records are complete and endorsed and all in-process controls made (1.7.11), that QC data comply with the finished product specification (1.7.13), and that all investigations relating to the batch, including out-of-specification and out-of-trend results, are complete (1.7.16).

An unexpected deviation does not automatically stop certification: section 3 of Annex 16 allows it once the deviation has been investigated, its root cause corrected and its impact assessed as negligible. Certification is recorded in a register or equivalent document, kept up to date and available to the authority for at least five years (1.10.1). Until certification, the batch stays at the manufacturing site or moves under quarantine, and section 4.2 accepts electronic safeguards against premature release, such as validated computerised systems.

What Annex 11 adds when the record is electronic

Once the batch record and the certification live in software, EU-GMP Annex 11 (computerised systems) applies. The application must be validated and the IT infrastructure qualified. For batch records the clauses inspectors look at first are:

• Section 9, audit trails: a risk-based, system-generated record of GMP-relevant changes and deletions, with the reason documented, readable and regularly reviewed.
• Section 12.4, identity: the system records who entered, changed, confirmed or deleted data, with the date and time.
• Section 14, electronic signatures: the same impact as a handwritten signature within the company, permanently linked to the record, with the time and date applied.
• Section 15, batch release: only Qualified Persons may certify, the system identifies and records the person certifying, and certification uses an electronic signature.
• Section 8.2, printouts: for records supporting batch release, it should be possible to print a copy showing whether data changed after original entry.

US buyers will also ask about 21 CFR Part 11, the FDA rule on electronic records and signatures. The Annex 11 checklist for a cannabis ERP goes through all 17 clauses.

How Phyta GMP keeps the record

The table maps each requirement to what 365Phyta does and what remains your responsibility. "Designed to support" is deliberate: the system supports compliance; your quality system and your validation make you compliant.

Items not listed here, such as printouts showing changed data (Annex 11, section 8.2), are best checked in your own qualification: ask for them in a demo and cover them in your OQ and PQ.

The QP's question: can I release this batch?

The QP wants to know whether a batch can be released and defended in an inspection. In 365Phyta that answer sits on the lot: the executed batch record, the QC results against the specification for its market, the imported CoA, the status of every deviation and CAPA, the retention samples, and the signature that certified it. If a deviation is open or a test is missing, the release is blocked rather than left to a checklist.

Where 365Phyta fits

Phyta GMP (with Vanguard Production) is part of the Processor bundle (€349 per full user per month all-in) and the Integrated bundle, and runs production on Business Central Essentials, so no user needs a Premium licence. Importers that release batches from third countries can add Phyta GMP for importers for their QA and QP users. The validation pack is included with Processor and Integrated implementations for the first site. See 365Phyta for EU-GMP processors, the compliance overview and the glossary.

FAQ

Sources

1. EudraLex Volume 4, EU-GMP Part I, Chapter 4: Documentation (in operation since 30 June 2011).
2. EudraLex Volume 4, Annex 16: Certification by a Qualified Person and Batch Release (in operation since 15 April 2016).
3. EudraLex Volume 4, Annex 11: Computerised Systems (in operation since 30 June 2011).
4. EudraLex Volume 4, Annex 7: Manufacture of Herbal Medicinal Products.
5. Directive 2001/83/EC on the Community code relating to medicinal products for human use, Article 51.
6. European Commission, EudraLex Volume 4 (Annexes 15 and 19).
7. US FDA, 21 CFR Part 11: Electronic records; electronic signatures.

Last reviewed: September 2026. This page describes software capabilities; it is not legal or regulatory advice.