2018-2019 Compliance monitoring project: Good manufacturing practices for natural health products

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Compliance monitoring

Companies must hold a site licence to manufacture, package, label or import natural health products (NHPs) in Canada. When doing these activities, companies must follow good manufacturing practices requirements (NHP GMPs) in the Natural Health Product Regulations (NHPR). We grant site licences to companies who send all the required application documents in agreement with the NHPR. It is a company’s responsibility to comply with the applicable regulatory requirements. When we identify an issue, we take compliance and enforcement actions based on several factors such as the risk to your health.

In 2017, we did a proactive compliance monitoring project to check how 23 companies followed NHP GMPs. See the results of the project for natural health products. These findings led to our 2018 to 2019 project to check compliance of another 23 companies in Canada.

Learn about how we conducted this second project, what we found and what actions we took below.

Why we did this project

We found compliance issues ranging in severity at all companies during our first planned site visits to verify compliance with GMP requirements in 2017. As part of our continued proactive and risk-based approach, we did our second series of site visits in 2018 to 2019.

This time, we:

We monitor compliance to keep track of products in the Canadian market. The information you and regulators give us help improve the safety of NHPs in Canada.

What we focused on

Building on the 2017 project, we focused on the same 2 types of higher risk activities conducted by Canadian companies.

Manufacturers

They have a direct impact on NHP’s safety and quality. Clean equipment must be used by properly trained employees. Companies must test their products to make sure what is on the label is what ends up in the bottle. They need to keep good records of their supply chain and need a process for product recalls.

Companies that manufacture sterile products must follow added requirements in the NHP GMPs.

Importers

Many products are made outside of Canada. Importers must make sure that the products they bring into Canada are made in facilities that follow NHP GMPs. For example, they must make sure to test the products they import for safety and quality.

For this project, we focused on:

Examples of what our inspectors checked for:

What we did

Inspectors conducted site visits at 23 companies from November 2018 to April 2019. This represents about 3% of all companies with active NHP site licences in Canada.

The breakdown of companies selected:

The site visits took place in:

Inspectors conducted visits under the authority of inspectors’ powers stated in Section 23 of the Food and Drugs Act (FDA). Obstruction or providing false information to an inspector is an offence under section 24 of the FDA.

Inspectors spent 1 to 2 days at each company site and provided a summary of findings to the company after each visit.

In some cases, inspectors sampled products to detect any problem with the company's processes or test results. The types of tests conducted by our laboratories was based on the inspector's findings and the specific quality or safety concerns.

We do not consider these visits regular GMP inspections as we didn’t assign compliance ratings.

What we found

We found similar issues as in our 2017 project, such as:

We found compliance issues ranging in severity for all companies. We classified issues on the potential risk it poses to your health and safety. Refer to examples of risk classifications in the Good Manufacturing Practices guidance document for NHPs.

Table 1: Examples of findings during our project
Topic Examples of what we foundtable 1 note a Why this matters

Premises

(Section 45 of the NHPR and chapter 2.1.1 of the Good Manufacturing Practices guidance document)

  • The segregated area was not clearly marked.
  • The facility showed signs of deterioration or a lack of upkeep.
  • The measures to prevent pests from entering the premises and contaminating products were inadequate.
The building must be designed and constructed in a way that permits cleanliness and orderliness and prevents contamination. Regular upkeep is required to prevent deterioration of the premises. Products should not become contaminated because of unsanitary conditions. A clearly marked segregated area that is only accessible to authorized employees should be in place. This is important to restrict the availability of materials or products until their release by the quality assurance person.

Sanitation Program

(Section 48 of the NHPR and chapter 2.3.1 of the Good Manufacturing Practices guidance document)

  • The written sanitation program for the premises and/or equipment was inadequate or incomplete.
  • The manufacturing, packaging, labelling or storage areas were unclean or unsanitary.
  • Sporadic dust, powder or residue in some manufacturing areas or on equipment.

Sanitation of a building and employee hygiene affect the quality of NHPs.

The company and its employees must perform activities in areas that are:

  • free from environmental contamination
  • free from getting contaminated by another product

There must be:

  • a written sanitation program to inform employees of the expectation
  • the necessary steps to maintain sanitation

This assures the cleanliness of the building.

Operations

(Sections 49 and 50 of the NHPR and chapter 2.3.2 of the Good Manufacturing Practices guidance document)

  • The employees did not follow approved standard operating procedures.
  • No written procedures were in place for the critical activities performed at the site.
  • Raw and/or packaging materials were not held in segregated area until their release by the quality person.
  • No expiry date was established for raw materials.
  • There were no signed quality technical agreement(s) with the contractor(s).

Measures must be in place to maintain the integrity of a NHP from when the:

  • raw materials enter the building
  • finished product is released and distributed for sale

Companies must ensure that practices and procedures are in place for, where applicable:

  • material control
  • process control
  • the inspection program for contractors
  • product recall

Quality Assurance

(Section 51 of the NHPR and chapter 1.2.2 of the Good Manufacturing Practices guidance document)

Specifications

(Section 44 of NHPR and chapter 2.4.1 of the Good Manufacturing Practices guidance document)

  • The product specifications were inadequate or missing important information.
  • The company did not test products according to their finished product specifications.
  • Some products were sold before being approved by the quality assurance person.
  • There was no system for handling complaints and returned goods or it was inadequate.
  • The company did not investigate and document out of specification test results, deviations and/or borderline conformance.
  • The decisions made by the quality assurance person were not well recorded, signed and dated.

Quality assurance is the area concerned with sampling, specifications, testing, including documents and release procedures. Before releasing a product for sale, the quality assurance person must ensure each product:

  • is suitable
  • meets product specifications
  • has necessary and relevant tests done

A product’s specifications are the approved set of criteria to ensure a finished NHP is acceptable for its intended use.

There are two important aspects:

  1. product specifications are established and relevant for the product
  2. the manufacturer has a quality system in place

Testing of finished products complements the controls employed during the manufacturing and importing processes. Each manufacturer and importer must have:

  • accurate specifications
  • adequate quality systems
  • the right test methods

Where test methods exist (such as a pharmacopeia method), companies must not rely on quantification by input.

Quantification by input is acceptable only if there is no test method to determine the quantity of a medicinal ingredient.

Learn more about quantification by input in the Quality of Natural Health Products Guide.

Stability

(Section 52 of the NHPR and chapter 2.4.2 of the Good Manufacturing Practices guidance document)

  • There was no data, scientific rationale or program available to confirm a product's expiry date.

The stability program determines how long the NHP is expected to stay within its specifications under recommended storage conditions. To prove that an NHP meets its label claims at the expiry date, companies must have:

  • data, or
  • a scientific rationale

Sterile products

(Sections 59 of the NHPR and chapter 2.4.6 of the Good Manufacturing Practices guidance document)

  • The processes and/or equipment used to manufacture sterile products were inadequate.

The manufacturing of sterile products depends on special requirements to prevent the risks of contamination. GMPs are required to be implemented to meet the definition of a sterile product, through manufacturing or terminal sterilization. All methods must be validated.

Table 1 Notes
Table 1 Note a

Note: This is not a full list.

Return to table 1 note a referrer

What enforcement actions we took

We reviewed the whole picture of what we saw during our visits to assess general compliance of NHP GMPs.

To protect your health and safety, we:

Our actions included directing some companies to:

During 13 of the 23 site visits, we found issues serious enough that we sent regulatory letters to notify the company that we were:

As a result of these letters, 4 companies no longer hold a site licence and 2 of them no longer hold product licences. As such, we removed these companies on our online List of site licence holders and updated the licence status of products from our Licensed natural health products database. Any new applications for site licences would be considered at the time of submission.

Companies need to enforce measures to ensure that they meet the regulatory requirements. They are responsible for fixing problems when they occur. When possible, we gave companies the opportunity to correct issues during the site visits.

We listed further details on the issues identified and actions taken for each company or product below. All companies that still hold a site licence and/or product licences have addressed the issues to our satisfaction.

Once it is time to renew their site licence, we will assess to check if companies fail or meet regulatory requirements.

Table 2: Findings and enforcement actions at manufacturers (in some cases, also licensed to package, label and import)
Establishment name Province Where we identified issues table 2 note b Actions

Alphagreen Resources

ON
  • Premises
  • Operations
  • Quality Assurance
  • Stability

After the site visit, we sent the company regulatory letters about the:

  • issues we found
  • possible impact on their product licences and site licence if they did not address the issues

The company did not respond to our letter.

We suspended their product licences and site licence on May 16, 2019.

The company discontinued their product licences on May 31, 2019. The company’s site licence was cancelled on August 16, 2019.

Celex Laboratories Inc.

BC
  • Operations
  • Quality Assurance
  • Stability

After the site visit, we sent the company regulatory letters about the:

  • issues we found
  • possible impact on their product licences if they did not address the issues

We reviewed their response and found it to be adequate. No further follow-up from us is needed at this time.

GFR Pharma Ltd.

BC
  • Operations
  • Quality Assurance
  • Stability

After the site visit, we sent the company regulatory letters about the:

  • issues we found
  • possible impact on their product licences and site licence if they did not address the issues

We reviewed their response and found it to be adequate. No further follow-up from us is needed at this time.

Inopro Inc.

QC
  • Premises
  • Sanitation Program
  • Stability
  • Sterile Products

The inspector directed the company to stop selling 2 products because of sterility concerns:

  1. Sterilin NPN 80062600
  2. Sterilin without alcohol NPN 80078105

We allowed the company to sell the products again once they addressed our concerns.

After the site visit, we sent the company regulatory letters about the:

  • issues we found
  • possible impact on their product licences and site licence if they did not address the issues

We reviewed their response and found it to be adequate. No further follow-up from us is needed at this time.

Konsar Future Nutrition Inc.

QC
  • Premises
  • Sanitation Program
  • Operations
  • Quality Assurance
  • Stability

The inspector directed the company to stop selling all products. The company then recalled all their products on June 10, 2019. We issued an advisory to warn Canadians of the serious health risks these products may pose.

After the site visit, we sent the company regulatory letters about the:

  • issues we found
  • immediate suspension of their product and site licences on May 17, 2019

The company did not respond to our letter, so their licences were cancelled on August 16, 2019.

Laboratoire NewPharma GNTIK Inc.

QC
  • Operations
  • Quality Assurance
  • Stability

After the site visit, we sent the company regulatory letters about the:

  • issues we found
  • possible impact on their product licences and site licence if they did not address the issues

We reviewed their response and found it to be adequate. No further follow-up from us is needed at this time.

Laboratoires Sol-Labo Inc.

QC
  • Premises
  • Sanitation Program
  • Operations
  • Quality Assurance
  • Stability

We informed the company of the issues we found. The nature of these issues did not need other regulatory action at this time. When it is time to renew their site licence, we will check if those issues are addressed.

Nexpharma Inc.

ON
  • Operations

We could not assess all the NHP GMP requirements we planned because the company was not doing all activities at the time of our review.

We informed the company of the issues we could check during the visit. The nature of these issues did not need other regulatory action at this time. When it is time to renew their site licence, we will check if those issues are addressed.

NNS Organics Limited

NS
  • Premises
  • Sanitation Program
  • Operations
  • Quality Assurance
  • Stability

After the site visit, we sent the company regulatory letters about the:

  • issues we found
  • possible impact on their product licences and site licence if they did not address the issues

We reviewed their response and found it to be adequate. No further follow-up from us is needed at this time.

NutraLab Canada Ltd.

ON
  • Premises
  • Sanitation Program
  • Operations
  • Quality Assurance

After the site visit, we sent the company regulatory letters about the:

  • issues we found
  • possible impact on their product licences and site licence if they did not address the issues

We reviewed their response and found it to be adequate. No further follow-up from us is needed at this time.

BioRéversa (9339-0458 QC Inc.)

QC
  • Premises
  • Sanitation Program
  • Operations
  • Quality Assurance
  • Stability

After the site visit, we sent the company regulatory letters about the:

  • issues we found
  • possible impact on their product licences and site licence if they did not address the issues

We reviewed their response for the product licences and found it to be adequate. The company asked that we discontinue their site licence, so they are no longer licensed to manufacture NHPs. No further follow-up from us is needed at this time.

Table 2 Notes
Table 2 Note b

See "What we found" section for examples of compliance issues

Return to table 2 note b referrer

Table 3: Findings and enforcement actions at importers (in some cases also licensed to package and label)
Establishment name Province Where we identified issuestable 3 note c Actions

Aperture Energetics Inc.

ON
  • Premises
  • Operations
  • Quality Assurance
  • Stability

After the site visit, we sent the company regulatory letters about the:

  • issues we found
  • possible impact on their product licences and site licence if they did not address the issues

We reviewed their response for the product licences and found it to be adequate. They did not renew their site licence and the company is no longer licensed to import NHPs. No further follow-up from us is needed at this time.

Bend Beauty Inc.

NS
  • Operations
  • Quality Assurance
  • Stability

We informed the company of the issues we found. The nature of these issues did not need other regulatory action at this time. When it is time to renew their site licence, we will check if those issues are addressed.

BioSteel Sports Nutrition Inc.

ON
  • Operations
  • Quality Assurance
  • Stability

After the site visit, we sent the company regulatory letters about the:

  • issues we found
  • possible impact on their product licences and site licence if they did not address the issues

We reviewed their response and found it to be adequate. No further follow-up from us is needed at this time.

Classical Remedia Ltd.

ON
  • Operations
  • Quality Assurance
  • Stability

We informed the company of the issues we found. The nature of these issues did not need other regulatory action at this time. When it is time to renew their site licence, we will check if those issues are addressed.

Collega International Inc.

ON
  • Operations
  • Quality Assurance
  • Stability

We informed the company of the issues we found. The nature of these issues did not need other regulatory action at this time. When it is time to renew their site licence, we will check if those issues are addressed.

Dicentra

ON
  • Operations
  • Quality Assurance
  • Stability

We informed the company of the issues we found. The nature of these issues did not need other regulatory action at this time. When it is time to renew their site licence, we will check if those issues are addressed.

Eastern Currents Distributing Ltd.

BC
  • Operations
  • Quality Assurance
  • Stability

The inspector directed the company to stop labelling products as they did not have a licence to do so. We allowed the company to label products as of July 19, 2019 since they amended their site licence.

After the site visit, we sent the company regulatory letters about the:

  • issues we found
  • possible impact on their product licences and site licence if they did not address the issues
We reviewed their response and found it to be adequate. No further follow-up from us is needed at this time.

Iovate Health Sciences International Inc.

ON
  • Operations
  • Quality Assurance

We informed the company of the issues we found. The nature of these issues did not need other regulatory action at this time. When it is time to renew their site licence, we will check if those issues are addressed.

Jeunesse Global Marketing Ltd.

AB
  • Operations
  • Quality Assurance
  • Stability

We informed the company of the issues we found. The nature of these issues did not need other regulatory action at this time. When it is time to renew their site licence, we will check if those issues are addressed.

Nutrabolt Distribution Canada ULC

ON
  • Operations
  • Quality Assurance
  • Stability

We informed the company of the issues we found. The nature of these issues did not need other regulatory action at this time. When it is time to renew their site licence, we will check if those issues are addressed.

Nutrition Zone Products Inc.

BC
  • Premises
  • Sanitation Program
  • Operations
  • Quality Assurance
  • Stability

After the site visit, we sent the company regulatory letters about:

  • the issues we found
  • possible impact on their product licences and site licence if they did not address the issues

We reviewed their response and did not find it to be adequate. We suspended their product licences and site licence on July 30, 2019. The company gave us more details to reinstate their licences as of February 24, 2020. No further follow-up from us is needed at this time.

Visalus Sciences Canada Inc.

ON
  • Operations
  • Quality Assurance
  • Stability

We informed the company of the issues we found. The nature of these issues did not need other regulatory action at this time. When it is time to renew their site licence, we will check if those issues are addressed.

Table 3 Notes
Table 3 Note c

See "What we found" section for examples of compliance issues

Return to table 3 note c referrer

What we will do with the results of this project

Our project, which included laboratory testing, allowed us to collect information on: We use what we find to:

We will continue to update you on our proactive monitoring activities.

In response to the compliance issues identified and to complement our paper-based licensing process, we are implementing a pilot NHP GMP inspection program in 2021. The pilot will be an in-depth assessment of the NHP GMP requirements. 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 Canadians 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.

Who is responsible for the safety of NHPs

Any company that manufactures, packages, labels or imports NHPs is responsible for their safety and must follow the Natural Health Product Regulations. This includes having a valid site licence before conducting these activities. Refer to the List of site licence holders.

To sell an NHP in Canada and to become a product licence holder, a person must:

Retailers

Sell NHPs with a valid 8-digit product licence number (NPN or DIN-HM).

Use the Licensed natural health products database to check if the NHP you are selling has a valid licence.

Consumers

Buy NHPs that have an 8-digit NPN or DIN-HM number on the label.

Use the Licensed natural health products database to check if the NHP you are buying has a valid licence.

If you have questions about health products, speak with your health care provider. This will help you avoid taking something that may interact with medications or other products you are already taking.

This project shows how Health Canada regulate the safety, efficacy and quality of NHPs. When a company or product does not follow the Food and Drugs Act and its regulations, we act on it based on several factors, including the risk posed to your health.

How to report a complaint about an NHP or an NHP facility

We want to know if you have a complaint about:

Report your complaint using the Health product complaint form.

Examples of complaints:

For general questions related to the safety of health products, contact toll-free 1-800-267-9675 or by e-mail at info@hc-sc.gc.ca.

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