Terminology used in the drug and health products inspections database (DHPID)

We have put together a list of commonly used terms that are specific to Health Canada inspections.

Terms

Activity(ies)

For domestic buildings: activities of products for which the building is licensed or registered.

For foreign buildings: a list of activities of products for which the building has been inspected.

Category(ies)

For domestic buildings: categories of products for which the building is licensed or registered.

For foreign buildings: categories of products for which the building has been inspected.

City

The Canadian city where the inspection was conducted.

Clinical Trial Application (CTA)

The control number assigned to the clinical trial application.

Control number

The reference number assigned to the clinical trial application (CTA).

Currently licensed

Indicates that the inspected building holds a valid establishment licence, if applicable.

Currently registered

Indicates that the inspected building currently holds a valid establishment registration, if applicable.

For cells, tissues and organs (CTO), it indicates that the inspected establishment currently hold a valid CTO registration number.

Deficiencies

A high-level summary of the observation(s) noted during the inspection.

Drug name

The name of the investigational drug used in the inspected clinical trial.

Enforcement Actions

Compliance and enforcement actions taken by Health Canada, in accordance with the Food and Drugs Act and associated Regulations and Health Canada's Compliance and Enforcement Policy (POL-0001).

Establishment

A building or group of buildings that is conducting licensable activities under the Food and Drugs Act or its associated Regulations.

Establishment name

The name of the inspected company.

Initial Inspection Deficiencies (IID)

The IID report is a summary page providing a preliminary, high-level summary of the observations made during the inspection. The IID report is posted before the inspection report card (IRC).

Inspection Outcome

A description of the overall inspection rating assigned to an establishment.

Inspection Report Card (IRC)

The IRC is a summary which gives a more detailed description of the observations made during the inspection, compared to the IID. The IRC includes a plain language summary of the observations.

Measures taken by Health Canada

The steps taken by Health Canada after the inspection to compel compliance with the Food and Drugs Act and its associated Regulations, including enforcement actions.

Observation number

The order in which the deficiency/observation is listed.

Province

The Canadian province where the inspected establishment is located.

Rating

Result of an inspection as either compliant or non-compliant.

Reference number

Health Canada assigns a unique reference number to each company it inspects. The reference number is different than the establishment licence or registration number.

Registration number

The registration number is assigned at the time of issuance of the registration and remains the same.

• For cells, tissues and organs, the registration number is assigned to an establishment.
• For blood, the registration number is assigned to the inspected building.

Risk Classification

The inspector(s) classify observations according to their risk to health or safety:

• Risk 1: high risk
• Risk 2: medium risk
• Risk 3: low risk

Risk classification is also known as 'risk rating' and 'risk rating classification.'

Site

The alphanumeric identifier used to distinguish different buildings with the same establishment name.

Sponsor

An individual, corporate body, institution or organization that conducts a clinical trial.

Status of Current Establishment Licence

For medical device inspections, it indicates the status of the Medical Device Establishment Licence: active, proposal to suspend establishment licence, suspended, cancelled (by Health Canada or by Company).

Summary of observations

A more detailed, plain-language summary of the observation than in the IID. The summary describes the nature of the issue observed by the inspector.

Suspension

Health Canada has legislative powers to suspend or terminate a Product Licence, Establishment Licence, Registration and Clinical Trial Authorization.

Terms and Conditions

A list of any terms and conditions that the licensee shall comply with to keep their licence.

Trial Phase

The phase of a clinical trial that was inspected, commonly classified into (1, 2, 3, 4 or other).

Type of inspection/Inspection type

Inspection types are identified as initial or new, regular, re-assessment, re-inspection, targeted or for-cause inspection.

• New or initial: A new inspection is the first inspection, to verify if a company's activities comply with the Regulations.
• Regular: A regular inspection is routinely scheduled after a company has completed their first inspection.
• Re-assessment: A re-assessment takes place when an inspector decides that a company that received a compliant inspection rating, with observations, needs to be inspected sooner than regularly scheduled. The inspection is focused on, but not restricted to, those requirements of the Food and Drugs Act and its associated regulations where violations were observed.
• Re-inspection: A re-inspection takes place if a company receives a non-compliant rating during a previous inspection. We focus on the observations identified during the previous inspection when a non-compliant rating has occurred.
• Targeted: A targeted inspection is a non-routine inspection, also known as a 'for cause' inspection. We carry out this type of inspection any time we are concerned that a company may not be following the laws that apply to them.