Draft for consultation: Quality of natural health products guide: Introduction
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Complying with the regulations helps ensure that consumers are not placed at risk due to deficiencies in the safety, efficacy or quality of your NHP. Product quality is fundamental to the safety and efficacy of all NHPs.
Product quality
Quality monitoring and finished product testing complement the controls employed during the manufacturing, packaging, labeling and importing processes. Product testing is integral to product release and includes test methods, acceptance criteria, test results, and records to demonstrate that your NHP meets its specifications.
This guide:
- provides guidance on the analytical tests needed to demonstrate the quality of your NHP
- including tests to be performed at the raw material stage, tests to be performed prior to product release, and stability tests for the most common dosage forms
- provides information on ingredient characterization
- can also help you to identify and address potential issues related to product quality throughout the life of the product
When establishing specifications, you should take into consideration which tests are completed at the raw material stage or during manufacturing. For example:
- testing for residual solvents and pesticides at the raw material stage may eliminate the need to perform these tests at the finished product stage
- testing for microbial contamination at the raw material stage or during manufacturing does not eliminate the need to perform this test on the final dosage form
The collection methods for raw materials and the manufacturing processes for NHPs can differ significantly from those used for other types of health products, such as pharmaceutical drugs.
Review your current specifications for your NHP against the information in this guide.
For information on GMP for NHPs, refer to the NHP GMP guide. It provides guidance on complying with the requirements of Part 3 (GMP) of the regulations.
Roles and responsibilities
The quality of NHPs sold in Canada is a shared responsibility among all parties involved in the production and sale of the product. The roles and responsibilities for each party are outlined in this section of the guide.
PL holders, manufacturers (including contract manufacturers), packagers, labellers, storers, importers, distributors, and testers all have roles and responsibilities related to product quality.
- Refer to the glossary for a description of PL holder.
- Refer to the Site licensing guidance document and the NHP GMP guide for descriptions of the other terms.
As a PL holder, you are responsible for:
- establishing and updating product specifications, including stability specifications, in accordance with the regulations and the information in this guide. This includes ensuring:
- compliance with the quality requirements set out in section 44 of the regulations
- the specifications meet the most up-to-date version of the pharmacopoeias and other internationally recognized standards applicable to your NHP
- ensuring your licensed NHP is manufactured, packaged, labelled, imported, distributed and stored in accordance with Part 3 (GMP) of the regulations
- ensuring your NHP is handled and labelled in such a way as to ensure its quality to the end of its shelf life
- responding to Health Canada's requests for more information or clarification (for example, on testing)
- documenting and addressing quality-related issues
- documenting and maintaining all quality information and ensuring it is current, accurate and sufficient to support the quality of your NHP
- note that section 58, under Part 3 (GMP) of the regulations, states: Every person required under this Part to maintain a record that relates to a lot or batch of an NHP shall maintain that record for a period of 1 year following the expiry date of the NHP to which that record relates
As a manufacturer (including contract manufacturers), packager, labeller and/or importer, you are responsible for:
- ensuring NHPs are manufactured, packaged, labelled, imported and stored in accordance with Part 3 (GMP) of the regulations
- maintaining records of NHP testing, as required, and ensuring the testing records comply with the regulations
- refer to the NHP GMP guide for more information on records
- ensuring established product specifications, including stability specifications, comply with the regulations and are in accordance with the information in this guide
- documenting and maintaining all quality information, including quality-related issues, and ensuring it is current, accurate and sufficient to support the quality of the NHP
Section 52 of the regulations states that manufacturers and importers are responsible for determining the period of time during which the NHP will maintain its purity and physical characteristics and its medicinal ingredient(s) will maintain their quantity per dosage unit and their potency when stored under its recommended storage conditions or, if it does not have recommended storage conditions, when stored at room temperature.
PL holders may rely on another party to, for instance, create specifications, manufacture their NHP, test the product prior to its release for sale or put a stability study in place. In such instances, both the PL holder and the contracted party (company) must establish clear roles and responsibilities to ensure:
- all steps are properly controlled
- applicable regulatory requirements are met
- all data and records are maintained appropriately
- refer to the NHP GMP guide for more information on records
Outsourced (contracted) activities should be governed by means of a quality agreement (written agreement) that is clearly understood, signed and dated by all parties. The agreement should specify who is responsible for performing each key function and for developing and maintaining documents and records. This will help you demonstrate the regulatory compliance for your NHP. The regulations identify the PL and/or SL holder as ultimately responsible for ensuring that processes are in place to control outsourced activities.
PL holders must ensure the parties that they contract follow the GMP requirements of the regulations. All quality systems should include the control and review of any outsourced activities.
- Refer to the NHP GMP guide for more information on quality agreements.
When submitting a PL application or amendment application, proprietary information may be provided to Health Canada in an Natural Health Product Master File (NHP-MF). An NHP-MF enables the manufacturer of a medicinal ingredient or raw material to provide proprietary information directly to Health Canada without disclosing the information to the PL applicant.
- Refer to the NHP MAP for more information on NHP-MFs.