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Draft good manufacturing practices guide for natural health products: Overview, about NHP quality systems

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Document change log:
Version Date Nature of and reason for the change
V 3 December 1, 2015 (Current version of the guide)
V 4 TBD 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:

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 document identifies the responsibilities of the distributor for the GMP related to storage, distribution and transportation. Warehouses or other storage facilities used by the following people must also comply with the GMP requirements:

Note: 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 the NHP.

Testing is also not a licensable activity under Part 2 of the regulations. However, 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. Thus, activities and records related to testing must comply with GMP.

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

Scope

This guide applies to all types of NHPs, including:

For additional guidance on related topics, consult:

Notes about guidance documents in general

Guidance documents 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.

Guidance documents like this one are meant to help industry understand how to comply with the regulations. They also provide guidance to Health Canada staff, so that rules are enforced fairly and consistently.

Health Canada assesses NHP sites for their compliance with the Food and Drugs Act (act) and associated regulations. When we conduct an assessment or inspection, we use this document as a guide to evaluate your compliance with the GMP requirements for NHPs.

We highly recommend that you follow the GMP as described in this document. However, we will consider other means of complying with the GMP requirements if you can either:

  • demonstrate that the alternative way is equal to or more stringent than what is presented in this guide or
  • provide appropriate scientific rationale to support the alternative way 

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.

Sections 8 and 9 of the act state that no person shall sell any NHP that is adulterated or advertised (including on its label) in a manner that’s:

  • false, misleading or deceptive or
  • likely to create a wrong impression about its character, value, quantity, composition, merit or safety

For site licensing and GMP, “sale” is not only release to the market. It also captures the sale from a manufacturer to the product licence holder when the manufacturer is not the party releasing to market.

Throughout this document, we refer to guidance documents that apply 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. If NHP stakeholders are aware of and recommend other references be added, Health Canada will consider those references and add them to this document when deemed appropriate.

GMP regulations by activity

Table 1 outlines which activities apply to each section of the regulations. It’s a checklist to help you. 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.

Table 1: GMP regulations by activity
Section of the regulations Manufacturing Packaging Labelling Importing Distributing
43. Prohibition ✔ ✔ ✔ ✔ ✔
44. Specifications ✔ ✔* X ✔ 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

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. You must not place consumers at risk due to poor NHP safety, efficacy or quality or for not complying with the regulations.

Guiding principles

You must meet the requirements that are outlined in the regulations and clarified in this guidance. This guide is meant to help you comply with the GMP requirements under the regulations. You will need the help and commitment of personnel and suppliers at all levels of your site and organization to achieve compliance.

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 be specifically 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 here to emphasize their relationships and fundamental importance to the production and control of NHPs.

Quality system

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, complexity of your activities and 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:

Good manufacturing practices for NHPs

GMPs are a part of both production and quality assurance. They ensure that NHPs are produced and controlled consistently.

To meet GMP requirements, you must have:

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

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:

For examples of quality risk management processes and applications, consult the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)’s guidance document:

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

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