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

Purpose

This 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 record-keeping 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. Table 2 on this page lists the minimum record-keeping requirements for an activity.

For more information, consult:

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 (for more information on what to include in a CAPA plan, refer to Appendix E – Corrective and preventive action process in the Good manufacturing practices guide for natural health products (GUI-0158), unless your inspection exit notice contains only risk 3 or no observations. In this plan, you are to address the risk 1 and 2 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.

Table 1: GMP regulations that apply to activities
Section of the regulations	Manufacturing	Packaging	Labelling	Importing	Distributing
43. Prohibition	✔	✔	✔	✔	✔
44. Specifications	✔	✔*	✔*	✔	X
45. Premises	✔	✔	✔	✔	✔
46. Equipment	✔	✔	✔	✔*	X
47. Personnel	✔	✔	✔	✔	✔
48. Sanitation program	✔	✔	✔	✔	✔
49. Operations	✔	✔	✔	✔*	✔*
50. Operations	✔	✔	✔	✔	✔
51. Quality assurance	✔	✔	✔	✔	✔
52. Stability period	✔	X	X	✔	X
53. Records - manufacturers	✔	X	X	X	X
54. Records - packagers	X	✔	X	X	X
55. Records - labellers	X	X	✔	X	X
56. Records - importers	X	X	X	✔	X
57. Records - distributors	X	X	X	X	✔
58. Record - maintenance	✔	✔	✔	✔	✔
59. Sterile NHPs	✔	✔	X	X	X
60. Ophthalmic use	✔	✔	X	X	X
61. Lot or batch samples	✔	X	X	✔	✔
62. Recall reporting	✔	X	X	✔	✔
✔ = applicable * = where applicable, depending on the nature of the activities. For example, when packaging a liquid product in its immediate container, it may be necessary to have specifications available for microbiological testing of the product. X = not applicable

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.

You must have a documentation control system that properly documents, records and tracks all stages of manufacturing, packaging, labelling, storage, testing and distribution. Table 2 lists the minimum record-keeping requirements.

Table 2: Record-keeping requirements for activities
Record	Manufacturer	Packager	Labeller	Importer	Distributor
Master production document	Maintain	None	None	Maintain	None
Batch record	Maintain	Maintain	Maintain	Access^{Table 2 Footnote *}	None
Test results: raw materials	Maintain	None	None	Access^{Table 2 Footnote **}	None
Test results: packaging materials	None	Maintain	None	Access	None
Test results: finished product	Maintain	None^{Table 2 Footnote ***}	None	Maintain	None
Specifications: raw materials	Maintain	None	None	Access	None
Specifications: packaging materials	None	Maintain	None	Access	None
Specifications: finished product	Maintain	None^{Table 2 Footnote ***}	None	Maintain	None
Stability	Maintain	None	None	Maintain	None
Ingredients List	Maintain	None	None	Maintain	None
Products List	Maintain
Complaints	Maintain
Recall	Maintain
Sanitation program	Maintain
Table 2 Footnote 1 As an importer, maintain batch records when a medicinal ingredient is quantified by input. Use the batch record to control the release of products where one or more medicinal ingredients are quantified by input. Return to table 2 footnote * referrer Table 2 Footnote 2 As an importer, maintain certificates of analysis for medicinal ingredients quantified by input. Use these certificates to ensure that the finished product contains the correct medicinal ingredient and that it was tested correctly prior to use. Return to table 2 footnote referrer Table 2 Footnote 3 For packagers of liquid products, documents demonstrating microbial controls to mitigate the risk of contamination during the filling process, or microbiological test results obtained after packaging, must be maintained. Return to table 2 footnote * referrer Maintain: Indicates the party will keep and make readily available such records. Access: Indicates the party does not need to keep these records but will have ready access to them. None: Indicates the party does not need to have such records.

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 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 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.

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Page details

2026-04-24

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