Glossary

Terms used across this site

ALCOA+

The nine attributes a GMP record must have — attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available — used as the test for data integrity in PIC/S PI 041-1.

Ampoule

A sealed single-dose glass container opened by snapping the neck; it cannot be re-closed, so the contents are drawn and used in one operation.

API

Active pharmaceutical ingredient — the substance in a medicine that produces the therapeutic effect, as distinct from everything added around it.

Aseptic processing

Manufacture in which a sterile product, container and closure are brought together under controlled conditions that keep them sterile, because the filled unit cannot be sterilised afterwards.

ATC code

The WHO Anatomical Therapeutic Chemical classification, which places a substance in an organ-system and therapeutic-chemical group; it is a classification, not an authorisation.

Batch (lot)

A defined quantity produced in one process so that it is uniform throughout, identified on every pack by its LOT number.

Bioburden

The count of viable micro-organisms present in a material, on a surface or in a solution before it is filtered or sterilised.

CAPA

Corrective and preventive action — correct the problem found, remove the cause so it does not recur, then verify that the action worked.

CCS

Contamination control strategy — the documented, site-wide plan that links every microbial, particulate and pyrogen control into one justified whole, required by EU GMP Annex 1 (2022 revision).

CoA

Certificate of analysis — the tested results for one specific batch set against its specification, issued when that batch is released.

CoPP

Certificate of a Pharmaceutical Product — a WHO-format certificate issued by the regulatory authority of an exporting country, at a product owner's request, to support registration of that product in an importing country.

CTD

Common Technical Document — the five-module dossier structure (ICH M4) in which product quality, non-clinical and clinical information is compiled for submission.

DataMatrix

The two-dimensional ECC200 barcode printed on the carton, encoding GTIN, batch, expiry and serial number in GS1 Application Identifiers.

Depyrogenation

A validated dry-heat process that destroys bacterial endotoxin on glass and metal components — conventionally demonstrated as at least a three-log reduction — rather than merely killing organisms.

Deviation

A documented departure from an approved procedure, parameter or specification, which must be investigated and assessed for impact before the batch can be released.

DMF

Drug master file — a confidential dossier held on a substance, component or packaging material that an authority may review by reference rather than through the applicant.

EPCIS

The GS1 standard by which trading partners exchange serialisation events — commissioned, packed, shipped, received — so that a pack's movement can be reconstructed.

Excipient

Any ingredient other than the active substance; in an oil-solution ampoule this is the oil carrier and the co-solvent that keeps the active in solution.

Excursion

A temporary departure of storage or transport conditions from the labelled range, assessed against stability data before the affected stock is judged fit or unfit.

FEFO

First expired, first out — stock is issued in order of expiry date rather than order of receipt, so the shortest-dated pack moves first.

GDP

Good distribution practice — the requirements that keep a medicine's quality intact through storage and transport after release, set out for the EU in the 2013/C 343/01 guidelines.

GMP

Good manufacturing practice — the body of requirements ensuring a medicine is consistently produced and controlled to the quality its intended use demands.

GTIN

Global Trade Item Number — the GS1 identifier of the trade item itself, carried on the pack under Application Identifier 01.

HVAC

Heating, ventilation and air conditioning — the plant that delivers filtered air, room pressure cascade, temperature and humidity to a cleanroom, and therefore its classification.

ICH

The International Council for Harmonisation, whose guidelines set the common technical expectations referenced throughout this site — among them Q1A(R2) stability, Q2(R2) analytical validation, Q3C(R9) residual solvents, Q3D(R2) elemental impurities, Q7, Q8(R2), Q9(R1), Q10 and Q12.

In-process control

A check made during manufacture — fill volume, seal integrity, tablet hardness, appearance — used to keep the process inside its limits while it is running, not after it has finished.

INN

International Nonproprietary Name — the single generic name assigned to a substance by WHO so it is identified the same way worldwide.

Media fill

An aseptic process simulation in which sterile growth medium is filled in place of product, then incubated, to demonstrate that the line and its operators can hold sterility.

MOQ

Minimum order quantity — the smallest quantity of a given presentation we will schedule as a production run, driven by batch size and changeover, not by preference.

OOS

Out of specification — a test result falling outside its approved acceptance criteria, which triggers a defined investigation before any disposition decision.

PQR

Product quality review — the periodic, normally annual, review of a product's batches, deviations, complaints, changes and trends, used to confirm the process remains in a state of control.

Qualified Person

In the European Union, the named individual who certifies each batch before release under Article 51 of Directive 2001/83/EC; other jurisdictions place equivalent personal responsibility on a designated authorised person.

Quarantine

The status — physical, electronic, or both — in which material is held and cannot be used or dispatched until a documented release decision is made.

Rx-only

Prescription-only — the product may be supplied only against a prescription and used under the supervision of a qualified prescriber.

Serialisation

Giving every saleable pack its own unique serial number, recording it against the batch, and reporting its status so an individual carton can be checked rather than only its batch.

SmPC

Summary of product characteristics — the structured document written for prescribers and pharmacists that states composition, indications, dosage, contraindications, warnings, interactions and handling.

Specification

The list of tests, analytical procedures and acceptance criteria that a material, intermediate or finished product must meet to be judged conforming.

SSCC

Serial Shipping Container Code — the unique GS1 identifier of a logistic unit such as a case or pallet, carried under Application Identifier 00 and used to aggregate the packs inside it.

Stability study

Storage of a product under defined temperature and humidity conditions, following the ICH Q1A(R2) framework, to establish its shelf life, storage statement and in-use limits.

Sterility assurance

The combined design, process, environmental and monitoring controls that give confidence a batch is sterile — confidence that end-product sterility testing alone cannot provide.

TOC

Total organic carbon — the measure of organic residue used to judge pharmaceutical water quality and the effectiveness of equipment cleaning rinses.

WADA

The World Anti-Doping Agency, which publishes the Prohibited List — a mandatory International Standard under the World Anti-Doping Code, revised annually and entering into force each 1 January.

WFI

Water for injections — the highest-grade pharmacopoeial water, produced and distributed under continuous control, and the only water used in the formulation of sterile products.