How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080): Glossary, definitions, resources

Glossary

ASR: alternate sample retention
ALR: annual licence review
API: active pharmaceutical ingredient
API FB annex: active pharmaceutical ingredient foreign building annex
BPI: bulk process intermediate
C: compliant
CoC: certificate of compliance
DEL: drug establishment licence
DIN: drug identification number
EDQM: European Directorate for the Quality of Medicines and Healthcare
EJ: extra-jurisdictional
EU: European Union
FB: foreign building
FB annex: foreign building annex
FDA: Food and Drugs Act
FDF: finished dosage form
FDR: Food and Drug Regulations
GMP: good manufacturing practices
ISO: International Organization for Standardization
LoA: letter of authorization
MHRA: Medicines and Healthcare products Regulatory Agency
MRA: mutual recognition agreement
NC: non-compliant
NERBY: new evidence required by
OSE: onsite evaluation
OTC: over-the-counter
PIC/S: Pharmaceutical Inspection Cooperation Scheme
SMF: site master file
SRF: site reference file
WHO: World Health Organization
TGA: Therapeutic Goods Administration

Definitions

These definitions explain how terms are used in this document. If there is a conflict with a definition in this document and a definition in the Food and Drugs Act (FDA) or Food and Drug Regulations (FDR), the definition in the act or regulations prevails.

Acknowledgment of application acceptance

A notice that an application has been accepted and an application number has been assigned.

Active ingredient

A drug that, when used as a raw material to fabricate a drug in dosage form, provides its intended effect. (FDR, section C.01A.001)

Active pharmaceutical ingredient (API)

An active ingredient used to fabricate a pharmaceutical. (FDR, section C.01A.001)

Also includes an active ingredient used to fabricate a drug of non-biological origin listed in Schedule C to the FDA.

Active pharmaceutical ingredient foreign building annex (API FB annex)

A list of foreign buildings that fabricate, package/label and/or test non-sterile APIs, non-sterile API intermediates and non-sterile atypical APIs. This annex is part of the drug establishment licence (DEL).

Active pharmaceutical ingredient (API) intermediate

A material (isolated or not) produced during the processing of an API that undergoes further molecular change or purification before it becomes a final API.

Alternate sample retention (ASR) annex

A list of foreign buildings that retain samples of imported product on behalf of the Canadian importer or distributor to comply with the C.02.025 requirement of the FDR. This annex is part of the DEL.

API set out in List A that is for veterinary use

A list of certain antimicrobial APIs that are important in human medicine. Health Canada has put a number of measures in place to help limit the development of resistance to these medically important antimicrobials.

ASR building

A foreign building that retains samples on behalf of an importer and distributor to comply with the C.02.025 requirement of the FDR.

Atypical active pharmaceutical ingredient

Active ingredients used in human pharmaceutical drugs, as well as pharmaceutical excipients or as ingredients in natural health products (NHPs), foods and cosmetics. These ingredients meet recognized standards other than good manufacturing practices (GMPs).

Bulk process intermediate (BPI)

An active ingredient used to fabricate either a drug of biological origin that is listed in Schedule C to the FDA or a drug that is listed in Schedule D to the FDA. (FDR, section C.01A.001)

Certificate of compliance (CoC)

A certificate issued by a regulatory authority attesting to the GMP compliance of a recognized building in that country. In Canada, a CoC is issued by Health Canada.

Corrective action

Steps taken by the regulated party to address the specified deficiencies (non-compliance with the law). Corrective action is taken to prevent a deficiency from happening again.

Compliance history

A foreign building's history of conformity with good manufacturing practices as outlined by legislative or regulatory requirements.

Compliant (C)

At the time of the assessment, the foreign building has demonstrated that the activities it conducts comply with the act and its associated regulations. A "C" rating does not mean that there are no observations, corrective actions required or other compliance and enforcement actions taken.

Critical observation

Observation of a critical deviation from the FDR that describes a situation that may produce an immediate or latent health risk due to a lack of drug safety information. Observations that involve fraud, misrepresentation or falsification under the FDA and associated regulations are also considered critical.

Dosage form

A drug product that has been processed to the point to where it's now in a form that may be administered in individual doses (unless otherwise defined in the FDR). In this guidance document, this term is also referred to as a finished dosage form (FDF).

Drug

Any substance or mixture of substances fabricated, sold or represented for use in:

diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals
restoring, correcting or modifying organic functions in human beings or animals or
disinfecting premises in which food is fabricated, prepared or kept

(FDA, section 2)

In Divisions 1A and 2 of the FDR, "drug" does not include:

a dilute drug premix
a medicated feed as defined in subsection 2(1) of the Feeds Regulations, 1983
an active ingredient that is for veterinary use and is not an API
an API for veterinary use that is not required to be sold pursuant to a prescription and is also a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations
a drug that is used only for the purposes of an experimental study in accordance with a certificate issued under section C.08.015 of the FDR

(FDR, section C.01A.001(2))

Drug establishment licence (DEL)

A licence issued to a person in Canada to conduct licensable activities in a building that has been inspected and assessed as being in compliance with the requirements of Part C, Divisions 2 to 4 of the FDR.

DEL screening completion notice

A notice that the DEL screening of an application has been completed

Drug identification number(DIN)

An 8-digit number assigned by Health Canada to a drug in dosage form before it's marketed in Canada. It uniquely identifies any drugs sold in a dosage form in Canada. The DIN is located on the label of prescription and non-prescription drugs that have been evaluated and authorized for sale in Canada.

A DIN uniquely identifies the following drug characteristics:

fabricator
drug product name
active ingredient or ingredients
strength of active ingredient
dosage form
route(s) of administration
species (for veterinary drugs only)

Ethical drug

A drug that, in accordance with federal legislation, does not require a prescription but is generally prescribed by a medical practitioner (for example, nitroglycerine).

Extra-jurisdictional (EJ) inspection

An inspection that occurs outside of the jurisdiction of a regulatory authority.

Extra-jurisdictional (EJ) certificate of compliance (CoC)

A certificate issued by a regulatory authority attesting to the GMP compliance of a recognized building outside of the regulatory authority's jurisdiction.

Fabricate

To prepare and preserve a drug for the purposes of sale. This definition applies to Divisions 1A, 2, 3 and 4 of the FDR. (FDR, section C.01A.001)

Finished dosage form (FDF) intermediate

Any physical mix, starting when any 2 ingredients (for example, active ingredient, antioxidant, preservative, filler, binder, solvent) are first added to the drug lot being fabricated and before it becomes a drug in dosage form. Partially processed drug product intermediates, in-process drugs or bulk drugs are examples of FDF intermediates. Atypical APIs with antioxidants, preservatives or stabilizers added are not considered FDF intermediates. These are classified as atypical APIs.

Foreign building

A building outside of Canada where the following licensable activities are conducted for drugs that are sold in Canada:

fabrication
packaging/labelling
testing

Foreign building annex

A list of foreign buildings that have been assessed by Health Canada as being compliant with the requirements of Part C, Divisions 2 to 4 of the FDR. This annex is part of the DEL.

Foreign establishment name

The name of the foreign establishment that is or will be engaged in licensable activities (also referred to as foreign building name in this document).

Full GMP evidence

A GMP evidence package consisting of an inspection report, corrective actions (if applicable) and a site master file.

GMP screening acceptance notice

A notice that the GMP screening of evidence submitted for a foreign building has been deemed acceptable based on the requirements outlined in GUI-0080.

GMP screening deficiency notice

A notice that a deficiency has been identified with the GMP evidence and that the application review and clock have been paused. A response is required by the date specified in the request.

Hybrid inspection

An inspection conducted remotely (using technology to communicate, share and review documentation) and with a short, targeted onsite visit to evaluate critical aspects that cannot be assessed remotely.

Letter of authorization (LoA)

A letter written and signed by the party who submitted GMP evidence documents that gives Health Canada authorization to process the importer's application.

Medical gas

Any gas or mixture of gases manufactured, sold, or represented for use as a drug. For information, consult Good manufacturing practices (GMP) for medical gases (GUI-0031). (FDR, section C.02.002)

MRA country

A country that is a participant to a mutual recognition agreement (MRA) with Canada. (FDR, section C.01A.001)

Mutual recognition agreement (MRA)

An international agreement that provides for the mutual recognition of compliance certification for good manufacturing practices for drugs. (FDR, section C.01A.001)

New evidence required by (NERBY)

The date when new supporting GMP evidence must be submitted to Health Canada as part of an application to renew a foreign building on a DEL.

Non-compliant (NC)

At the time of the assessment, the foreign building has not demonstrated that the activities it conducts comply with the act and its associated regulations.

Over-the-counter (OTC)

A drug that does not appear on a schedule or the Prescription Drug List or is not recommended to appear on any schedule.

Package/label

To put a drug or API in its immediate container and/or to affix the inner or outer label to the drug or API. This includes repackaging and relabelling previously packaged and labelled drugs. (FDR, section C.01A.001)

Pharmaceutical

A drug other than a drug listed in Schedule C or D to the FDA. This definition applies to Divisions 1A, 2, 3 and 4 of the FDR. (FDR, section C.01A.001)

Product category

In this guidance, includes pharmaceutical, active ingredient, vaccine, biologic, radiopharmaceutical, controlled drugs and narcotics or any other product category designated by the Minister.

Product type

In this guidance:

Sterile: prescription, OTC, veterinary, category IV
Non-sterile: prescription, OTC, medical gas, veterinary, category IV

Quality agreement

A formal document between parties (for example, the Canadian DEL holder and the contractor) that defines the responsibilities and duties of both parties for all aspects of a drug's quality.

For more guidance on the content of a quality agreement, consult Good manufacturing practices guide for drug products (GUI-0001).

Qualified authority

A regulatory authority that is part of the Pharmaceutical Inspection Cooperation/Scheme (PIC/S).

Qualified body

Non-regulatory authorities that are associated partners to the Pharmaceutical Inspection Cooperation/Scheme (PIC/S).

Recognized building

A building that a regulatory authority (that is designated under subsection C.01A.019(1)) has recognized as meeting its good manufacturing practices standards to fabricate, package/label and/or test a drug. (FDR, subsection C.01A.001(1))

Regulatory authority

A government agency or other entity in an MRA country that:

has a legal right to control the use or sale of drugs within that country and
may take enforcement action to ensure that drugs marketed within its jurisdiction comply with legal requirements

(FDR, section C.01A.001)

Release testing of the API

Testing done to ensure the API meets the specifications of the ingredient. Each API must have proper specifications and test methods to help ensure that the API sold or used in further manufacturing is safe and meets its relevant standard (FDA, Schedule B)

Remote inspection

An inspection conducted remotely using technology to communicate, share and review documentation without having to undertake an onsite visit.

Terminal sterilization

The sterilizing of a drug in its final closed container.

Test

To perform the tests, including any examinations, evaluations and assessments, as specified in Part C, Division 2 of the FDR.

Resources

Laws and regulations

Forms

Good manufacturing practices

International guidance documents

Page details

2025-07-02

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