The language of the medical export chain.

21 CFR Part 11

The US Food and Drug Administration rule on electronic records and electronic signatures. It sets requirements such as audit trails, access control and signature manifestation (name, date, time and meaning).

ALCOA+

Data-integrity principles for GMP records: Attributable, Legible, Contemporaneous, Original and Accurate, plus Complete, Consistent, Enduring and Available.

Annex 11

The EU-GMP annex on computerised systems: risk management, validation, data, audit trails (section 9), electronic signatures (section 14), security and periodic review.

Annex 15

The EU-GMP annex on qualification and validation of premises, equipment, utilities, processes and systems.

Annex 16

The EU-GMP annex on certification by a Qualified Person and batch release.

Annex 19

The EU-GMP annex on reference and retention samples.

Annex 7

The EU-GMP annex on the manufacture of herbal medicinal products, covering starting materials, processing and documentation.

Audit trail

A secure, computer-generated, time-stamped record of who created, changed or deleted GMP-relevant data, and when.

Batch record

The master batch record is the approved instruction for making a product; the executed batch record is the completed, signed record of one specific batch.

BfArM

Bundesinstitut für Arzneimittel und Medizinprodukte, Germany's Federal Institute for Drugs and Medical Devices. Its Federal Opium Agency (Bundesopiumstelle) issues medical cannabis permits and import and export authorisations under the MedCanG.

BtMG

Betäubungsmittelgesetz, the German Narcotics Act. It governed medical cannabis until the MedCanG replaced it for this purpose on 1 April 2024.

Cannabis flos

The pharmaceutical name for dried cannabis flower used as a medicinal product or starting material.

CAPA

Corrective and preventive action: the quality-system process that removes the cause of a deviation or defect and prevents it from recurring.

CoA

Certificate of analysis: the laboratory document stating a batch's test results against its specification.

Country adapter

In 365Phyta, the market-specific package of authority report formats, labels, specification limits and permit workflow for one country.

Deviation

A departure from an approved instruction or specification. It must be documented, investigated and closed; a QP cannot release a batch with an open deviation.

EU-GMP

Good Manufacturing Practice for medicinal products in the EU, published by the European Commission in EudraLex Volume 4: Part I for medicinal products, Part II for active substances, plus annexes.

FEFO

First expired, first out: a picking rule that ships the lots closest to expiry first.

GACP

Good Agricultural and Collection Practice: the EMA guideline for cultivating and collecting starting materials of herbal origin, including medical cannabis.

GAMP 5

ISPE guidance on a risk-based approach to compliant GxP computerised systems, widely used to plan the validation of ERP and quality systems.

GDP

Good Distribution Practice: the EU guidelines (2013/C 343/01) for the wholesale distribution of medicinal products, covering storage, transport, returns and recalls.

Import and export authorisation

A per-shipment permit under the 1961 Single Convention system. The exporting country's export authorisation refers to the importing country's import authorisation for the same consignment.

INFARMED

Portugal's National Authority of Medicines and Health Products. It authorises the cultivation, manufacture, wholesale, import and export of medical cannabis under Decreto-Lei 8/2019.

IQ, OQ and PQ

Installation qualification (the system is installed as specified), operational qualification (it operates as specified) and performance qualification (it performs as intended in your process).

Lot genealogy

The traceable link from a finished lot back through processing and harvest to the plant batch and mother plant, and forward to every customer who received it.

MedCanG

Medizinal-Cannabisgesetz, the German Medical Cannabis Act, in force since 1 April 2024. It requires a BfArM permit (section 4) and per-shipment import or export authorisations (sections 12 and 14).

Narcotics stock book

The register of receipts, issues and stock of a controlled substance for each period. It must reconcile and be available to the authority.

Qualified Person (QP)

The person who certifies that each batch of a medicinal product was manufactured and checked in line with GMP and its authorisation before it is released (EU Directive 2001/83/EC).

Single Convention on Narcotic Drugs

The 1961 UN treaty that places cannabis under international control and sets up the system of national licences, estimates and import and export authorisations.

Last reviewed: September 2026. See also compliance and markets.