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.

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.

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Audit Trail

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

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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.

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Chain of Custody

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

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Cold Chain

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

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Denied-Party Screening

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

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Drug Accountability

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

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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.

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EU GMP Annex 11

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

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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.

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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.

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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.

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Investigational Medicinal Product (IMP)

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

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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).

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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.

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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.

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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.

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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.

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Temperature Excursion

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

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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.

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UN1845 (Dry Ice)

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

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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.

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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.

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