Annex 3A to the Good manufacturing practices guide - Schedule C drugs (GUI-0026): Glossary

On this page

• Acronyms and abbreviations
• Definitions

Acronyms and abbreviations

Bq

Becquerel

Ci

Curie

CNSC

Canadian Nuclear Safety Commission

GBq

Gigabecquerel

GMP

good manufacturing practices

HPLC

high performance liquid chromatography

MBq

Megabecquerel

mCi

Millicurie

PET

positron emission tomography

PER

positron-emitting radiopharmaceutical

Definitions

These definitions explain how terms are used in this document. They apply to the terms used in this annex and may have different meanings in other contexts. Definitions quoted from other documents are identified in brackets at the end of the definition. If there is a conflict with a definition in the Food and Drugs Act (act) or Food and Drug Regulations (regulations), the definition in the act or regulations prevails.

More applicable definitions can be found in the Good manufacturing practices guide for drug products (GUI-0001).

Aseptic system

A set of equipment with related controls and procedures used to achieve a sterile environment free from contaminating organisms or particles.

Carrier

A stable element that is added, in detectable quantities, to a radionuclide of the same element, usually to facilitate processing of the radionuclide.

Component

A unit of a drug, other than a radionuclide, separately packaged in a kit; or an empty vial or other accessory item in a kit. (C.03.205)

Cross-contamination

Contamination of a drug or raw material or in-process intermediate with another drug, raw material or in-process intermediate. In multi-product facilities, potential cross-contamination can occur throughout the manufacturing process.

Dedicated

Facility or piece of equipment used only in the fabrication of a particular product or a closely related group of products.

Drug

A drug that is listed in Schedule C to the act that is in dosage form or a drug that is an active ingredient of biological origin that can be used in the preparation of a drug listed in that Schedule. (C.03.001)

Half-life

Time during which the initial radioactivity of a radionuclide is reduced to one-half.

Hot cell

A total containment cabinet or workstation shielded with lead used for manufacturing (radiosynthesis) and/or purification of radiopharmaceuticals.

Kit

A package that is intended to be used in the preparation of radiopharmaceuticals and that contains 1 or more separately packaged units of a drug, other than a radionuclide, and may contain empty vials or other accessory items. (C.03.205)

Master formula

A document or set of documents specifying the raw materials with their quantities, their radioactivity and the packaging materials, together with a detailed description of the procedures and precautions required to fabricate a specified quantity of a finished product as well as the processing instructions, including in-process controls.

Multiple-dose container

A container that permits withdrawal of successive portions of the contents without changing the strength, quality or purity of the remaining portion for articles intended for parenteral use only.

No-carrier-added

Indicates the status of a radionuclide sample where no stable atom of the same element has been added purposely.

Pharmaceutical

A drug other than a drug listed in Schedule C or D to the act. (C.01A.001)

Radioactive concentration

Amount of radioactivity per unit volume such as mCi/mL or MBq/mL.

Radioactivity

The number of disintegrations per unit of time given in Becquerel (Bq) or Curie (Ci) units.

Radiochemical purity

The extent to which a drug is free from undesirable or adulterating radiochemicals, as defined by specifications.

Radionuclide

An unstable atom that undergoes spontaneous transformation with emissions of subatomic particles and/or photons of energy.

Radionuclide dose calibrator

Device measuring the radioactivity of a radioactive sample in Becquerels (Bq) or Curies (Ci).

Radionuclide generator

A radioactive parent and daughter contained in an ion exchange column or dissolved in a suitable solvent in a liquid-liquid extraction system where the radioactive daughter is separated from its parent by elution from the ion exchange column, or a solvent extraction procedure. (C.03.001)

Radionuclidic purity

The extent to which a drug radioisotope is free from undesirable or adulterating radionuclides (as defined by specification), expressed as a percentage of the radioactivity of the specified radionuclide to the total radioactivity of the source.

Radiopharmaceutical

A drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. (C.03.201)

Specific activity

Amount of radioactivity per unit mass or per mole (such as mCi/mg, MBq/mg or mCi/mole, Mbq/mole).

Total containment glove box

An aseptic suite of totally enclosed environment at negative pressure, whose primary purpose is to maintain a sterile environment, with the additional purpose of radioactivity workspace localization.

Total radioactivity

Amount of radioactivity present in the total volume of a reconstituted preparation or total volume of an eluate or solution, expressed as mCi or MBq.