2019-2020 Compliance Monitoring Project: Good manufacturing practices for natural health products
We actively monitor the compliance of regulated parties and health products in Canada.
In 2017, Health Canada conducted a compliance monitoring project to verify how 23 companies followed good manufacturing practices (GMP) for natural health products (NHPs). See the 2017 results.
From October 2019 to January 2020, we visited a number of companies from the 2017 project to confirm that they had properly addressed issues identified during the first visit. Learn about how we conducted this project, what we found and what actions we took.
On this page
- Why we did this project
- What we focused on
- What we did
- What we found
- What enforcement actions we took
- What we will do with the results
- For more information
Why we did this project
We wanted to verify and monitor:
- the effectiveness of our 2017 project
- the companies' proper implementation of their committed corrective actions
Our findings help us improve our compliance monitoring efforts and the safety of NHPs in Canada.
What we focused on
Of the 23 companies that we visited in 2017, we chose to revisit those that still held a site licence and where serious findings were noted at the time. Following the 2017 visits, we notified these companies that the findings could affect their product licences and/or site licence if the compliance issues were not addressed adequately. We also reviewed the corrective actions they proposed. If implemented appropriately, these actions were deemed to be adequate.
During the follow-up visits, inspectors verified whether specific corrective actions, committed by the companies in 2017, had been implemented properly. The focus of each visit was unique, based on each company's initial findings. We verified compliance to specific GMP requirements of the Natural Health Products Regulations (NHPR) for the following areas:
- sanitation programs
- specifications
- operations
- quality assurance
- stability
What we did
Inspectors conducted 5 follow-up site visits of companies in British Columbia, Ontario and Quebec.
Inspectors spent 1 day at each company site and provided a summary of findings to the company after each visit.
What we found
During our visits, we found new and recurring compliance issues ranging in severity at 4 of the 5 companies. We classified these issues according to the potential risks they pose to the health and safety of people in Canada.
For examples of risk classifications, see the Good Manufacturing Practices Guidance Document for NHPs.
What enforcement actions we took
We considered the nature and extent of the issues that we found and took actions to protect the health and safety of people in Canada where necessary.
For example, we found that a company had not implemented corrective actions appropriately from the 2017 project. As a result of this serious issue, we suspended the company's site and product licences. We reinstated them after the company had taken appropriate action.
Companies are responsible for:
- putting measures in place to ensure that they meet the regulatory requirements
- taking action to fix problems when they occur
When possible, companies are given the opportunity to correct issues identified during the site visits.
Details on the issues identified and actions taken for each facility are listed in the table below. You can review the previous compliance monitoring project report from 2017.
We also assessed whether these companies continued to meet their regulatory obligations, including the implementation of corrective actions, at the time of the renewal of their site licence. Site licences are renewed for 1, 2 or 3 years based on the consecutive length of time a company has held a site licence.
| Establishment name | Province | Where we identified issues (sections of the NHPR) |
Actions |
|---|---|---|---|
Abundance Naturally Ltd. |
ON |
|
We informed the company of the issues. Based on the low level of risk, we will re-evaluate the company's corrective actions when it comes time to renew its site licence. |
Les Services David Jones Inc. |
QC |
|
We informed the company of the issues. Based on the low level of risk, the issues were addressed when the company's site licence was renewed, which was soon after our site visit. The company resolved the issues and no other actions were necessary at the time. |
Lernapharm (Loris) Inc. |
QC |
No findings based on what was reviewed |
Not applicable |
Les Eaux Saint- Léger/Waters Inc. |
QC |
|
We informed the company of the issues. Based on the low level of risk, the company's corrective actions will be evaluated at the time of their site licence renewal. |
Naturo Aid Pharmaceutical Inc. |
BC |
|
After the site visit, regulatory letters were sent noting the issues and notifying the company of the potential impact on its product licences and site licence if the issues were not addressed. |
What we will do with the results
We use what we find from our compliance monitoring projects to:
- give additional guidance to the industry on how to meet regulatory requirements
- improve the quality and safety of products in Canada
- inform us how we can improve our regulatory oversight of NHPs, including site licensing
This compliance monitoring project also gave us some information on how regulated parties implemented the corrective actions following our 2017 project. We will continue to keep people in Canada informed of our proactive monitoring activities.
After identifying the compliance issues in the original 2017 project, we followed up with a project in 2018-2019 and this one in 2019-2020. These compliance monitoring projects on NHPs helped inform our implementation of a good manufacturing practices (GMP) inspection program pilot for NHPs in 2021. The pilot is an in-depth assessment of the NHP GMP requirements. GMPs have an impact on product quality. The objective of the pilot is to strengthen compliance of the NHP industry with regulatory requirements. Increased compliance with regulatory requirements protects the health and safety of people in Canada by ensuring NHPs are safe, effective and of high quality. A dedicated NHP GMP inspection program may be developed following the completion and evaluation of the pilot.