Good manufacturing practices guide for natural health products (GUI-0158): Overview, about NHP quality systems

This guidance comes into force on March 4, 2026. It replaces version 3.

Publication date: September 4, 2025
Effective date: March 4, 2026
Replaces: Good Manufacturing Practices Guidance Document (Version 3.0)

On this page

• Purpose
• Scope
• Notes about guidance documents in general
• Introduction
• About NHP quality systems

Document change log

Version	Date	Nature of and reason for the change
3.0	December 1, 2015	n/a
4.0	September 4, 2025	The guide is presented in a more user-friendly format that follows the order of the regulations under Part 3 (GMP) of the Natural Health Products Regulations. Additional and clearer guidance is provided for most of the GMP topics presented in this guide, including more clarity on importer-related activities.

Purpose

This guide will help you understand and comply with Part 3 on good manufacturing practices (GMP) of the Natural Health Products Regulations (regulations). This guide is for people, including organizations and companies, conducting activities or performing roles that involve natural health products (NHPs). This includes:

• manufacturing
• packaging
• labelling
• importing
• distributing
• storing
• testing
• holding the product licence

Distributing and storing are not licensable activities under Part 2 of the regulations. However, NHPs must be distributed and stored according to the requirements set out in Part 3 of the regulations. This guide identifies the responsibilities of the distributor for the GMP related to storage (including storage during transportation) and distribution. Warehouses or other storage facilities used by the following people must also comply with the GMP requirements:

• importers
• those who store for retailers
• those who store to sell directly to individual consumers
  • such as solely through an e-commerce platform

The GMP requirements of the regulations do not apply to storage activities at retail establishments that sell directly to consumers. However, this exemption does not apply to a retail establishment that manufactures or imports NHPs.

Finished product testing complements the GMP controls employed during the manufacturing, packaging and importing processes. As an integral part of product release, testing provides the results that are used to demonstrate whether an NHP meets its specifications. Activities and records related to testing must comply with GMP.

Refer to the glossary and acronyms used in this guide, as well as the references.

Scope

This guide applies to all types of NHPs, including:

• non-sterile NHPs, such as:
  • enzymes
  • probiotics
  • amino acids
  • herbal remedies
  • essential fatty acids
  • traditional medicines
  • vitamins and minerals
  • other products, such as certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes
• sterile NHPs, such as:
  • ophthalmic products
  • sterile water for irrigation
• homeopathic medicines

For additional guidance on related topics, consult:

• Site licensing guidance document on the requirements to get a site licence
• Natural health products management of applications policy on the requirements to get a product licence
• Quality of natural health products guide on the quality requirements for NHPs
• Finished product specifications form and Finished product specifications form user guide for the form to be submitted as part of your product licence application

Notes about guidance documents in general

Guidance documents (guides) provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the regulations and other applicable guidance documents.

Introduction

This guide interprets the requirements for GMP of Part 3 of the regulations. Health Canada engaged stakeholders throughout the various stages of developing this version of the guide.

Poor GMP conditions are likely to lead to the manufacturing and importing of NHPs that mislead consumers on the product's quality. Although an NHP may pass all its finished product specification tests, it may become contaminated or adulterated if manufactured or handled in poor GMP conditions.

Therefore, complying with the GMP requirements of the regulations is mandatory.

Throughout this guide, we refer to other guidance documents that apply specifically to pharmaceutical drugs (such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) quality guidelines). Although the scope of these references may not always include lower-risk health products such as NHPs, the GMP concepts and processes on which they provide guidance and other information are helpful for the NHP industry and stakeholders. Other references may be added as they become available.

GMP regulations by activity

Table 1 outlines which activities apply to each section of the regulations. A checkmark indicates that the section of the regulations applies to the activity specified. Note that you do not need a site licence to distribute under Part 2 of the regulations.

About NHP quality systems

If you hold a site licence or run an operation governed by Part 3 (GMP) of the regulations, you must comply with these requirements and with your product licence. Part 3 applies to when you manufacture, package, label, import, distribute, store or test NHPs.

Guiding principles

To meet Part 3 of the regulations, you must have a well-designed and properly implemented quality system (also known as a quality management system). It should meet or exceed the requirements for NHPs and incorporate both GMP and quality risk management.

The basic concepts of a quality system, GMP and quality risk management are inter-related. We have described them in this guide to emphasize their relationships and fundamental importance to the production and control of NHPs.

Quality system

A quality system is a framework of procedures, controls and resources that your organization should use to consistently:

• meet consumer expectations
• support continual improvement
• comply with regulatory requirements

A quality system incorporates GMP and covers all matters that individually or collectively influence the quality of an NHP. Consider the size of your operation (for example, small to medium size enterprises), the complexity of your activities, and the risk to your products and processes when developing a new quality system or modifying an existing one.

Make sure your NHP quality system is properly set up for manufacturing, packaging, labelling, importing, distributing, storing or testing NHPs.

You should:

• define and document your quality system
  • have a quality manual or equivalent documentation that describes the system and responsibilities of management
• outline management roles clearly and have senior or executive management participate actively in the quality system
  • their leadership is essential as they are ultimately responsible for making sure an effective quality system is in place
• make sure the quality system is resourced properly
  • define, communicate and implement roles, responsibilities and authorities throughout the organization
• design, plan, implement, maintain and improve your system continuously
  • this allows for the consistent delivery of products with proper quality attributes
• manage product and process knowledge throughout all lifecycle stages
  • for example, by using a process flow diagram
• design and develop NHPs in a way that considers GMP requirements
• evaluate, qualify and monitor suppliers for performance and compliance
• have processes in place to manage outsourced activities properly
• take preventive actions based on the results of product and process monitoring and deviation investigations
• make sure the quality assurance person (QAP) approves each batch of NHPs before they are sold
• implement a process for self-inspection and perform a quality audit to assess the effectiveness of your quality system regularly
  • these will help you identify ways to improve products, processes and the system

Good manufacturing practices for NHPs

GMP are a part of both production and quality assurance (QA). They ensure that NHPs are produced and controlled consistently.

To meet GMP requirements, you must have:

• a qualified QAP
• qualified and trained staff
• adequate premises
• suitable equipment and utilities
• suitable materials, containers and labels
• approved procedures and instructions
• suitable storage and transportation

You must only release raw materials, packaging materials and NHPs for use or sale if their quality is acceptable. The QAP makes sure that:

• the necessary and relevant tests are performed and ensure the quality of an NHP and
• quality principles are incorporated into all activities and decisions concerning NHPs

Quality risk management

Quality risk management is a systematic process used to assess, control, communicate and review risks that could affect the quality of a product over its lifecycle. It can be applied both proactively and retrospectively.

The principles of quality risk management are that the:

• evaluation of the risk to quality is based on scientific knowledge and experience with the process
  • is linked to the protection of the consumer
• level of effort, structure and documentation of the quality risk management process is in proportion to the level of risk

Consult ICH guideline Q9: Quality risk management for examples of tools for quality risk management (such as the Hazard Analysis and Critical Control Points (HACCP)).

Although NHPs are not within the scope of ICH guidelines, such references are helpful to the NHP industry and other stakeholders. The guidelines may help you gain a better understanding of GMP concepts and processes that also apply to NHPs.