About drug inspections
Before drugs can be sold to Canadians, they must meet high safety and quality standards. This is the case for drugs made in Canada or abroad. Learn about drug inspections, how the Government of Canada (GC) conducts them and our licensing practices.
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A drug inspection helps ensure drug companies are meeting Canada's high safety and quality standards. An on-site drug inspection is carried out on over 400 drug companies every year in Canada. Find the latest results of drug and health product inspections the Government of Canada conducts.
Inspection standards are strict, and are set out in the GC's Good Manufacturing Practices (GMP) Guidelines. These encourage ongoing improvement. They also allow the GC to spot minor problems before they become serious safety risks to Canadians.
All operations are inspected, including:
- packaging and labelling
What are good manufacturing practices?
Good manufacturing practices are safety and quality standards that companies must meet before a drug or health product can be sold to Canadians.
Companies are required to correct safety and quality problems. They must also keep detailed records, so unsafe products can be traced anywhere in the world and pulled from the market.
How often are inspections conducted?
Inspections are conducted every 2 years for:
- product packagers and labellers
- product-testing laboratories
Inspections are conducted every 3 years for:
Drug inspections for foreign sites
A foreign site drug inspection helps ensure drugs manufactured abroad meet Canada's high safety and quality standards. Drugs sold in Canada can contain ingredients from different countries. About 80% of the drugs Canadians rely on are now imported into Canada.
Drugs can only be imported for sale in Canada if good manufacturing practices are followed where they are made. We have agreements with countries around the world that meet international standards and follow these practices.
In many cases, we rely on inspections undertaken by trusted international regulatory partners and perform paper-based reviews of the information to make our own regulatory decisions. Health Canada also performs a small number of inspections of facilities outside Canada each year. Both on-site inspections and paper-based reviews are listed in the Drug and Health Product Inspections Database.
What inspectors look for
Our inspections are detailed, rigorous and follow international standards. Inspectors look for areas where companies are falling short in meeting the standards set out by the good manufacturing practices. Inspectors make "observations" when they see deficiencies in areas such as:
- sanitary conditions
- training of personnel
- record keeping
- written procedures
- storage facilities
- temperature control and ventilation
- product testing
The different types of observations include those that:
- do not pose a risk to safety
- could pose a risk to safety if not corrected
- terms and conditions are often applied
- pose a risk to safety
- in these cases, a non-compliant rating is issued and immediate measures taken
After a drug inspection
After completing the inspection, the inspector writes an inspection report and issues an overall rating to the company. This overall rating is classified as either compliant or non-compliant.
A compliant rating means that a company is complying with good manufacturing practices and the Food and Drugs Act.
It is common for a company to receive a compliant rating even if a number of observations have been identified. This is because drug production processes are complex and the standards for good manufacturing practices are high.
Companies may be required to take corrective actions. Terms and conditions may also be applied to the company's licence to ensure the ongoing health and safety of consumers.
A non-compliant rating means that a company is not complying with good manufacturing practices and the Food and Drugs Act. It also means observations have been made that could lead to immediate or potentially serious health risks to Canadians.
Companies could be required to take immediate corrective measures. In some cases, the GC will suspend or terminate a company's licence. If required, this can also include issuing recalls, public advisories and border restrictions.
Where possible, companies are given the opportunity to correct observations during an inspection. However, the GC always takes action when a risk to the health and safety of Canadians is identified.
Companies must provide Health Canada with a written corrective action plan for any observations identified with target dates for completion.
A follow-up inspection may be conducted to make sure the corrective actions have been taken.
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