Glossary of controlled-substance and GMP terms

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.

Counterparty qualification

Checking, before you trade, that a supplier or customer holds the licences or authorisations required for the substance or product, and keeping that evidence current. For controlled substances both parties must be licensed; GDP (chapter 5) also requires suppliers and customers to be qualified.

Country pack

In 365Phyta, the separate extension for one market: authority report formats, labels, specification limits and permit workflow. Packs for Germany and Portugal are in development; more are planned.

Destruction register

The record of every destruction of a controlled substance: what was destroyed, how much, when, how and who was present. National law sets the witness rule; in Germany, section 16 of the BtMG requires destruction in the presence of two witnesses and a written record. In 365Phyta Licensing, a destruction cannot be recorded without a witness who is a different person from the one recording it. 365Phyta records one witness per destruction.

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 (section 12), granted under the procedure of the Narcotics Foreign Trade Ordinance (section 14).

Controlled-substance officer

Common name for the person a licence holder appoints as responsible for controlled substances: keeping the stock book, supervising movements and destruction, and reporting to the authority. National law sets the exact title and duties. Often called the narcotics officer; for medical cannabis in Germany, the responsible person under the MedCanG.

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.

Psychotropic substance

A substance controlled under the UN Convention on Psychotropic Substances of 1971, such as many sedatives, stimulants and hallucinogens, as distinct from the narcotic drugs controlled under the 1961 Single Convention.

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).

Quota

A limit on how much of a controlled substance may be manufactured or imported. Under the UN system, each country’s annual estimates (narcotic drugs) and assessments (psychotropic substances), confirmed by the INCB, set the national ceiling; authorities may pass limits on to licence holders.

SGTIN

Serialised Global Trade Item Number: a GS1 GTIN plus a serial number, identifying one individual pack.

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.

SSCC

Serial Shipping Container Code: the GS1 number that identifies one logistic unit, such as a case or a pallet.

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