Glossary

The language of regulated logistics.

Plain definitions of the terms that govern how pharmaceutical and clinical material moves, from Part 11 and GDP to UN3373 and stability budgets.

Working out whether a sample is Category A or Category B? Walk the cascade in the free classifier.

21 CFR Part 11

The FDA regulation setting the conditions under which electronic records and electronic signatures are considered trustworthy and equivalent to paper records and handwritten signatures.

Read definition →

Audit Trail

A secure, time-stamped, computer-generated record of every create, change and delete to a record, that does not obscure previous information.

Read definition →

CAPA (Corrective and Preventive Action)

The process of identifying the root cause of a problem, correcting it, preventing recurrence and checking that the action was effective.

Read definition →

Chain of Custody

The unbroken, documented record of who held a shipment and when, from dispatch to delivery, ideally tamper-evident.

Read definition →

Cold Chain

The temperature-controlled supply chain that keeps a product within its required temperature range from manufacture to use.

Read definition →

Denied-Party Screening

Checking every party to a transaction against published lists of people and organisations you are prohibited or restricted from dealing with.

Read definition →

Drug Accountability

The requirement under GCP to account for all investigational product from receipt at a site through dispensing to return or destruction.

Read definition →

Electronic Signature

A deliberate, attributable act by a person to approve or authorise an electronic record, linked to that record so it cannot be transferred.

Read definition →

EU GMP Annex 11

The European GMP guideline governing computerised systems used in regulated activities, covering the system lifecycle, data integrity, security and suppliers.

Read definition →

Exempt Human or Animal Specimen

A patient or animal specimen for which there is minimal likelihood that pathogens are present, and which is therefore not regulated as an infectious substance for transport.

Read definition →

Export Control Classification Number (ECCN)

The code on the US Commerce Control List that identifies an item controlled under the EAR and the reasons it is controlled.

Read definition →

Good Distribution Practice (GDP)

The standard governing how medicinal products are stored, transported and handled across the supply chain so their quality is maintained from manufacturer to patient.

Read definition →

Good Manufacturing Practice (GMP)

The standard governing the manufacture of medicinal products so they are consistently produced and controlled to the quality appropriate for their intended use.

Read definition →

Investigational Medicinal Product (IMP)

A pharmaceutical form of an active substance or placebo being tested, or used as a reference, in a clinical trial.

Read definition →

IQ / OQ / PQ

The three qualification stages showing a system is installed correctly (IQ), operates as intended (OQ) and performs consistently in real use (PQ).

Read definition →

Manufacturing and Import Authorisation (MIA)

A licence authorising the manufacture or import of medicinal products, including the import of investigational product under an MIA(IMP), with QP oversight.

Read definition →

Marketing Authorisation (MA)

The approval that permits a medicinal product to be placed on the market in a jurisdiction, defining its approved conditions including storage.

Read definition →

Packing Instruction 620 (PI 620)

The packing instruction governing Category A infectious substances under UN2814 and UN2900: UN-certified triple packaging tested to a far higher performance standard than PI 650.

Read definition →

Packing Instruction 650 (PI 650)

The packing instruction governing UN3373 Category B biological substances: triple packaging, a 1 litre primary limit for liquids, and a 4 litre or 4 kg limit on the completed outer package.

Read definition →

Qualified Person (QP)

The individual who certifies that each batch of a medicinal product has been manufactured and tested in line with GMP and the marketing authorisation before it is released.

Read definition →

Responsible Person (RP)

The named individual accountable for GDP compliance at a licensed wholesale distributor, with the authority and knowledge to maintain the quality system.

Read definition →

Temperature Excursion

A departure from a product's approved storage or transport temperature range, handled as a deviation with assessment, disposition and CAPA.

Read definition →

Time At Elevated Temperature (TAET) and Stability Budget

The cumulative time-out-of-range a product can tolerate against its stability data, tracked so each excursion draws against a finite budget.

Read definition →

Triple Packaging

The three-layer packaging system required for infectious substances and exempt specimens: a primary receptacle, a leak-proof secondary packaging, and a rigid outer packaging.

Read definition →

UN1845 (Dry Ice)

The dangerous-goods classification for dry ice, solid carbon dioxide, a Class 9 hazard because it sublimates into gas.

Read definition →

UN2814 (Category A, Infectious Substance Affecting Humans)

The dangerous-goods entry for an infectious substance carried in a form capable of causing permanent disability, or life-threatening or fatal disease, in otherwise healthy humans.

Read definition →

UN2900 (Category A, Infectious Substance Affecting Animals Only)

The dangerous-goods entry for a Category A infectious substance capable of causing serious disease in animals but not in humans.

Read definition →

UN3172 (Toxins Extracted from Living Sources)

The Class 6.1 entry for a toxin extracted from a plant, animal or bacterial source and separated from the organism that produced it. UN3172 is the liquid entry and UN3462 the solid.

Read definition →

UN3245 (Genetically Modified Micro-organisms and Organisms)

The Class 9 entry for genetically modified material that is not an infectious substance but is capable of altering animals, plants or micro-organisms in a way that would not normally result from natural reproduction.

Read definition →

UN3291 (Regulated Medical or Clinical Waste)

The dangerous-goods entry for waste from the medical treatment of humans or animals, or from bio-research, that contains Category B infectious substances.

Read definition →

UN3373 (Category B Biological Substance)

The dangerous-goods classification for an infectious biological substance not in a form causing permanent disability or life-threatening disease in healthy people.

Read definition →

Wholesale Distribution Authorisation (WDA)

A licence authorising a company to procure, hold, supply or export medicinal products by wholesale, held under GDP with a named Responsible Person.

Read definition →

See it live in 25 minutes.

Eight guided flows: compliance review, DPS screening, Part 11 e-signature, custody chain, breach prediction, GDPR erasure and the validation report. Then a 90-day pilot on your own programme, fully creditable.

Book a 90-day pilot Compare the alternatives