Natural health products good manufacturing practices pre-inspection package: Overview

On this page

• Purpose
• Licensable activities
• Inspections
• We want your feedback
• Resources

Purpose

This new natural health products (NHP) good manufacturing practices (GMP) pre-inspection package is for anyone who conducts licensable activities involving NHPs. This includes:

• manufacturers
• packagers
• labellers
• importers

This package contains information on:

• licensable activities
• what to expect from an inspection
• giving us your feedback
• resources for more information
• GMP regulations that apply to licensable activities and distribution
• minimum requirements required for each licensable activity

Licensable activities

The licensable activities are defined as follows in section 1(1) of the Natural Health Products Regulations (regulations):

• Manufacturer: a person who fabricates or processes a natural health product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of a patient, compounds a natural health product for the purpose of sale to that patient
• Package (verb): to put a product in its immediate container
• Label (verb): to affix the inner or outer label of the natural health product
• Importer: a person who imports a natural health product into Canada for the purpose of sale

Distributing and storing are not licensable activities under Part 2 of the regulations. However, NHPs must be distributed and stored in accordance with the GMP requirements set out in Part 3 of the regulations and are subject to inspection. They are defined as follows in section 1(1):

• Distributor: a person who sells a natural health product to another person for the purpose of further sale by that other person
• Storage: a site, also called a warehouse, whose main purpose is to hold products, including natural health products

Testing is not a licensable activity under Part 2 of the regulations. However, records and activities related to testing are also subject to inspection.

Inspections

NHP GMP inspections are conducted to assess compliance with Part 3 of the regulations, with legislative authority for the regulations stemming from the Food and Drugs Act.

The scope of the inspection depends on the licensable activities being assessed. The length of time an on-site inspection takes will depend on the licensable activity being conducted, as well as the category and dosage form class of products involved. Note that we expect you to have all documentation related to the activity to be inspected at your site, as outlined in sections 53 to 58 of the regulations.

Table 1 on this page lists the Part 3 regulation that applies to an activity. For more information, consult:

• Good manufacturing practices guidance document
• Site licensing guidance document

An inspection will usually consist of the following components:

• Opening meeting:
  • includes a review of the purpose and scope of the inspection and site profile
  • includes a review of the inspection schedule, products or operations and procedures or records
  • includes confirmation of the site's key personnel and activities conducted
• Tour of the premises:
  • includes the critical steps and processes related to regulated activities
• Assessment:
  • includes a review of procedures, operations and records
  • includes interviews with personnel, to assess compliance with the requirements
• Documentation review:
  • involves fact-finding and spot checking procedures and records
  • includes selection of a representative number of products to review
• Closing meeting:
  • involves a summary of the inspection findings
  • includes a discussion of next steps in the inspection process
• Exit notice meeting:
  • involves a presentation of draft inspection exit notice and observations made

During an inspection, the inspector will record all deviations to Part 3 of the regulations as observations.

Following the inspection and exit notice meeting, you will be expected to submit a corrective and preventive action (CAPA) plan, unless your inspection exit notice contains no observations. In this plan, you are to address the observations noted (an inspection exit notice with a compliant rating may have observations and require a CAPA plan). The timeframe for submitting your response will be documented in the exit notice. It will vary depending on the compliance rating you received:

• 20 business days for a compliant inspection
• 90 calendar days for a non-compliant inspection

Table 1 outlines the regulations that apply to each NHP licensable activity and to distribution. A checkmark indicates that the section of the regulations applies to the activity. An X indicates that the section of the regulations does not apply to the activity. Note that a site licence is not required for distributing, storing or testing.

Consult the relevant guidance documents to determine the extent to which these requirements apply to your products.

You should ensure that the systems listed in this document are in place before manufacturing, packaging, labelling or importing NHPs.

An assessment of your site's compliance may include a review of applicable information in the checklists provided in this document. Note that these checklists are only a guide and do not include everything an inspector may review.

If you conduct multiple activities related to NHPs, you should ensure you meet all requirements for each activity. Depending on the products handled on site, other regulations may also apply. However, they would not be subject to inspection during your NHP GMP inspection. For example, the Medical Devices Regulations apply if you are processing medical devices.

We want your feedback

This new pre-inspection package is a way that we are helping the NHP industry achieve NHP GMP compliance and prevent non-compliance.

You can help us develop better and more effective tools by telling us what you think.

• Was the new pre-inspection package helpful?
• Did it answer most of your questions about the GMP inspection process for NHPs?
• Do you have any suggestions on how we can help you better prepare for a NHP GMP inspection?

Send us your feedback by emailing us at hpcrm.nhpinspection-inspectionpsn.cpsgr@hc-sc.gc.ca. Be sure to put "NHP GMP Pre-Inspection Package" in the subject line.

Resources

Legislation

• Food and Drugs Act
• Food and Drug Regulations
• Natural Health Products Regulations
• Official Languages Act

Guidelines and other documents

• Good manufacturing practices guidance document
• Quality of natural health products guide
• Finished product specifications form user guide
• A guide to Health Canada inspections
• Site licensing guidance document
• Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119)
• Drug and natural health products recall guide (GUI-0039)
• Evidence for homeopathic medicines guidance document
• Good manufacturing practices guide for drug products (GUI-0001)
• Guidance document: Labelling of natural health products
• Compliance and enforcement policy (POL-0001)
• Risk classification of good manufacturing practices (GMP) observations (GUI-0023)
• Recall policy for health products (POL-0016)
• Policy on accessing the premises of a regulated party remotely to verify compliance (POL-0138)