A Quality Assurance Person (QAP) is responsible for ensuring that Natural Health Products (NHPs) meet applicable quality requirements before they are made available for sale in Canada. Under Section 51 of the Natural Health Products Regulations, manufacturers, packagers, labellers, importers and distributors must have a qualified QAP with the training, experience and technical knowledge necessary to oversee their activities.
The QAP’s responsibilities extend beyond finished-product approval to include specifications, testing oversight, quality documentation, complaints, investigations, corrective and preventive actions (CAPA), and the procedures supporting an effective Good Manufacturing Practices (GMP) quality system.
Health Canada’s Good Manufacturing Practices Guide for Natural Health Products (GUI-0158), Version 4, effective March 4, 2026, provides detailed guidance on QAP responsibilities, qualifications, independence and quality system expectations. Health Canada has also published a draft revised Quality of Natural Health Products Guide, proposing updates to the guidance governing product specifications and quality assessment.
For current and prospective Site Licence holders, importers and distributors, understanding the QAP’s role is essential to maintaining GMP compliance. Organizations must ensure that their QAP has the qualifications, authority and resources necessary to make independent quality decisions and demonstrate compliance with Canadian requirements.
A Quality Assurance Person is the individual responsible for assuring the quality of an NHP before it is made available for sale. Section 51 of the Natural Health Products Regulations establishes the requirement for manufacturers, packagers, labellers, importers and distributors to have a QAP with training, experience and technical knowledge relevant to their activities.
The QAP serves a central function within the organization’s quality management system, overseeing the controls used to ensure that products comply with established specifications and applicable GMP requirements. Although quality assurance activities may involve multiple departments or external service providers, the QAP remains responsible for the quality decisions assigned to the position.
For example, an NHP manufacturer may employ personnel responsible for production, laboratory testing, sanitation and documentation, while the QAP reviews the information generated through those activities and determines whether the applicable requirements have been met. An importer may rely on a foreign manufacturer to conduct testing but still requires a QAP to assess the supporting documentation and approve the imported product before release.
Health Canada’s NHP GMP Guide, Section 51 – Quality Assurance identifies the QAP as the individual responsible for maintaining the quality system and assuring that products are suitable for sale. The role therefore extends beyond reviewing individual test results to overseeing the procedures, records and quality decisions that support compliance throughout the product lifecycle.
Under Section 51(1) of the Natural Health Products Regulations, every NHP manufacturer, packager, labeller, importer and distributor must have a QAP. This requirement applies to organizations performing these activities even where individual quality functions are conducted by third parties.
The distinction is particularly important for distributors, as distribution is not itself a Site Licence activity under Part 2 of the Regulations. Nevertheless, distributors remain subject to applicable GMP requirements under Part 3, including the obligation to have a qualified QAP.
For example, a Canadian distributor purchasing finished NHPs from a licensed domestic manufacturer may not require its own Site Licence if it performs no licensable activities. However, the distributor must still comply with applicable requirements governing quality assurance, storage, complaints, returns and distribution.
Similarly, a Canadian importer must have a QAP responsible for the quality oversight of imported products, even when manufacturing, packaging, labelling and testing occur outside Canada. The importer’s QAP must be able to evaluate relevant foreign manufacturing information and determine whether imported products satisfy Canadian requirements.
Health Canada’s Site Licensing Guidance Document provides further information on activities requiring a Site Licence, while the NHP GMP Guide identifies the GMP requirements applicable to different activities.
Section 51 establishes several responsibilities directly associated with quality assurance, while other provisions of Part 3 require QAP involvement in specifications, procedures and related GMP controls. Health Canada’s GUI-0158 guidance on quality assurance describes how these requirements should be implemented within an effective quality system.
Finished-product specifications establish the quality requirements that an NHP must meet before it can be sold in Canada. Under Section 44 of the Regulations, these specifications must address purity, medicinal ingredient identity and quantity, applicable potency requirements and the methods used to test or examine the product.
The QAP is responsible for approving specifications used in quality control and product release, along with changes that could affect product quality. This approval helps ensure that the requirements used to evaluate a product remain consistent with its Canadian product authorization and applicable regulatory requirements.
For example, a finished-product specification may establish acceptable limits for medicinal ingredient quantity, microbial contamination and other quality attributes. The QAP must ensure that the specifications are appropriate and that testing and supporting documentation provide sufficient evidence that the product meets those requirements.
The current finalized Quality of Natural Health Products Guide provides additional direction on product quality standards, specifications, analytical methods and supporting documentation.
Health Canada published a draft revised Quality of Natural Health Products Guide (Version 4.0) on July 20, 2026, proposing updated guidance on product specifications, quality assessment and testing. The revised guide is intended to reflect current scientific practices and provide clearer direction to manufacturers, importers, laboratories, product licence holders and QAPs.
The proposed guidance specifically identifies QAPs as responsible for reviewing and approving specifications used for product release. It also addresses the development and maintenance of specifications, confirmation that imported products meet Canadian requirements, stability testing and ongoing quality documentation.
The consultation closed September 20, 2026. Health Canada has indicated that a finalized version will follow its review of stakeholder feedback, with an appropriate transition and implementation period. Until then, organizations should continue following the applicable Regulations and finalized guidance while reviewing the proposed updates for potential impacts on their quality systems.
One of the QAP’s most important responsibilities is approving each lot or batch of an NHP before it is made available for sale. Section 51(4) expressly requires QAP approval, making finished-product release a critical control within the quality system.
Before approving a batch, the QAP must assess the applicable quality documentation and determine whether the product meets its established specifications and regulatory requirements. Depending on the operation, this assessment may include Certificates of Analysis, batch manufacturing records, laboratory results, deviation reports and other relevant information.
For example, a batch of NHP capsules may have completed manufacturing and packaging but still require review of its analytical results, production documentation and any deviations recorded during processing. The QAP must determine whether the available evidence supports release or whether additional investigation or corrective action is necessary.
Health Canada’s Section 51 GMP guidance emphasizes that products must not be released until their quality has been determined to be acceptable. The release decision must therefore be supported by appropriate documentation rather than the completion of manufacturing activities alone.
The QAP also has responsibilities extending to the materials and procedures used to manufacture, package, label and store NHPs. Under Sections 51(2) and 51(3), applicable materials, methods and procedures must receive QAP approval before use or implementation.
These requirements help establish controls before activities affecting product quality occur. For manufacturers, this may include approval of raw materials, packaging components, labels, manufacturing procedures and relevant production controls.
For example, a manufacturer introducing a new ingredient supplier must ensure that the material is appropriately evaluated and approved before being used in production. Similarly, a change to an established manufacturing procedure may require quality review to determine whether the change could affect product specifications or process controls.
The responsibilities differ for organizations that only import finished products. Health Canada’s GMP guidance clarifies that such importers do not need written procedures for approving or rejecting raw, packaging and labelling materials when those activities are not part of their operations. Nevertheless, they must maintain appropriate controls over the finished products they import.
The QAP plays a central role in investigating deviations and out-of-specification (OOS) results that may affect NHP quality. A deviation occurs when an activity departs from an established procedure, process or accepted standard, while an OOS result indicates that a material, product or relevant process parameter has failed to meet established requirements.
Health Canada’s GMP guidance on deviations and OOS investigations describes the QAP’s responsibility for evaluating the severity of deviations, investigating their causes and determining whether affected products can be released.
For example, an unexpected laboratory result showing that a medicinal ingredient falls outside its approved quantity tolerance requires investigation before the product can be released. The QAP must assess the validity of the result, consider whether other batches may be affected and determine whether additional testing, corrective action or product rejection is necessary.
The guidance also emphasizes that repeatedly testing a product until a passing result is obtained is not an acceptable approach to resolving an OOS result. Investigations must be scientifically justified, appropriately documented and supported by procedures that prevent unsupported quality decisions.
Section 51 also requires regulated organizations to investigate and record complaints concerning NHP quality and take corrective action when necessary. The QAP oversees the quality processes used to evaluate these complaints and determine whether they indicate broader product or manufacturing issues.
For example, a complaint involving an unusual product appearance, damaged packaging or unexpected product deterioration may require examination of the affected lot, manufacturing records, storage conditions and other available information. Depending on the findings, the investigation may identify the need for additional testing, supplier follow-up, corrective action or a product recall.
Returned products also require appropriate quality assessment. Under Section 51(5), NHPs returned after sale must receive QAP approval before they can be made available for further sale.
The QAP must therefore ensure that returned products are appropriately evaluated and that decisions concerning resale, quarantine or destruction are supported by documented evidence.
Where the foreign site has not completed testing required by the finished-product specifications, the Canadian importer must ensure that the missing testing is completed before release for sale, either internally or through a qualified third-party laboratory. Although these activities may occur outside Canada, the importer remains responsible for ensuring that imported NHPs meet applicable Canadian GMP and product requirements.
Health Canada’s GUI-0158 guidance on importation controls identifies an importation control system as an important component of the importer’s quality system. The QAP, supported by appropriate personnel, is responsible for confirming that imported products meet their specifications and Canadian regulatory requirements before release.
For example, an importer receiving finished NHPs from a U.S. manufacturer may rely on Certificates of Analysis and other records generated by that manufacturer. However, the Canadian QAP must still evaluate the documentation, determine whether required testing has been completed and ensure that the available information supports product release.
Where foreign testing does not address all applicable finished-product specifications, additional testing may be required before release. The QAP must also maintain appropriate oversight of foreign-site GMP compliance, product quality issues, transportation-related deviations and the documentation needed to support Canadian regulatory requirements.
Companies seeking to import NHPs without establishing their own licensed import operation may work with an existing Canadian Site Licence holder. Through dicentra’s NHP Importation Services, eligible products can be imported under an established Site Licence with associated quality assurance and regulatory support.
The Natural Health Products Regulations require a QAP to possess training, experience and technical knowledge relating to the organization’s activities and applicable GMP requirements. However, the Regulations do not establish a single mandatory academic degree or professional designation that automatically qualifies an individual to perform the role.
Instead, Health Canada’s QAP qualification guidance emphasizes demonstrated competence in the quality-related functions associated with the organization’s operations. A qualified QAP should understand GMP principles and have sufficient practical experience and technical knowledge to implement and maintain an effective quality system.
Depending on the organization’s activities, relevant competencies may include reviewing product specifications and Certificates of Analysis, interpreting laboratory results, evaluating batch records, developing written procedures, investigating deviations, implementing corrective actions, conducting internal audits and managing product recalls.
For example, the knowledge required of a QAP overseeing domestic NHP manufacturing may differ from that required of a QAP responsible for importing finished products from foreign facilities. Although both must understand the applicable GMP framework, their day-to-day responsibilities involve different processes, records and quality risks.
Organizations must maintain evidence demonstrating that their QAP is appropriately qualified. Health Canada’s guidance identifies written job descriptions, training records and documentation supporting the individual’s experience and technical knowledge as important evidence of qualification.
Health Canada’s GUI-0158 guidance recognizes that organizations may use a third-party QAP, particularly where smaller companies do not have the internal resources or expertise necessary to maintain an independent quality function.
The guidance emphasizes that quality assurance should operate independently from production, sales, marketing and other areas where actual or perceived conflicts of interest may arise. For smaller organizations, this may be achieved through robust internal controls or by engaging a qualified external QAP.
For example, a small NHP distributor may not require a full-time internal quality assurance department but must still maintain the procedures, documentation and qualified oversight necessary to meet its regulatory obligations. An appropriately qualified third-party QAP may support these functions, provided the arrangement establishes sufficient authority, access to information and oversight.
Outsourcing the QAP function does not remove the regulated organization’s responsibility for GMP compliance. The organization must ensure that the QAP is appropriately qualified, has the authority to make independent quality decisions and can access the records and information necessary to perform the assigned responsibilities.
Written agreements and clearly defined responsibilities are particularly important where quality functions are divided between internal personnel, external consultants, laboratories and other service providers.
The QAP’s responsibilities extend beyond individual product release decisions to maintaining the broader quality system used to control activities affecting NHP quality. Health Canada’s NHP GMP Guide identifies quality management, laboratory controls, importation controls and quality risk management as important components of an effective system.
A central responsibility involves ensuring that Standard Operating Procedures (SOPs) accurately describe how regulated activities are performed and that personnel follow those procedures consistently. Documentation must provide evidence that required activities occurred and that quality decisions were appropriately reviewed and approved.
The QAP also plays an important role in change control and corrective and preventive actions. When a manufacturer changes equipment, modifies a process or introduces a new supplier, the QAP may need to evaluate the potential impact on product quality and approve the associated changes.
Similarly, when an investigation identifies a recurring quality issue, the QAP must ensure that appropriate corrective actions address the underlying cause and that the effectiveness of those actions is evaluated.
Health Canada’s guidance also recommends periodic self-inspections to assess GMP compliance and identify opportunities for improvement. These assessments help organizations evaluate whether their procedures, records, personnel training and operational controls continue to meet applicable requirements.
An NHP GMP inspection may assess whether the organization has an appropriately qualified QAP and whether the quality system provides sufficient evidence that the QAP’s responsibilities are being performed.
Inspectors may examine the QAP’s job description, training and qualifications, product specifications, batch-release records, approved procedures, quality investigations and other documentation demonstrating the implementation of applicable GMP controls.
Health Canada’s NHP GMP Pre-Inspection Checklist for Importers specifically identifies QAP independence, qualifications, training records and documented responsibilities among the evidence inspectors may request.
For example, a company may have established procedures requiring QAP approval before product release, but an inspection may identify deficiencies if release records do not demonstrate that the required review occurred. Similarly, training records may be insufficient if they do not support the individual’s qualifications for the responsibilities assigned.
Organizations should therefore evaluate not only whether a QAP has been designated, but whether that individual has the qualifications, authority, resources and information necessary to perform the role effectively.
dicentra’s Natural Health Product GMP Training provides practical instruction on Canada’s GMP requirements, based on Health Canada’s latest Good Manufacturing Practices Guide for Natural Health Products (GUI-0158).
Designed for current and prospective Site Licence holders, Quality Assurance Persons (QAPs) and personnel involved in NHP operations, the online course covers the broader GMP framework, with particular emphasis on quality assurance responsibilities such as product specifications, batch release, laboratory controls, deviation investigations, corrective and preventive actions (CAPA) and documentation. Participants who successfully complete the training and assessment receive a certificate with a unique serial ID that can be maintained as part of their organization’s training records.
Ensuring that a QAP has the appropriate qualifications, authority and supporting quality systems is essential to maintaining NHP GMP compliance. With more than two decades of regulatory consulting experience, dicentra supports manufacturers, importers, distributors and Site Licence holders with quality management system development, Standard Operating Procedures (SOPs), product specifications, supplier qualification, quality agreements, GMP assessments and inspection readiness.
For companies importing NHPs into Canada, dicentra also offers NHP Importation Services through its established Canadian Site Licence. These services include foreign-site GMP assessments, product documentation review, QAP oversight and finished-product release for eligible products, helping companies meet their Canadian regulatory obligations.
Explore dicentra’s NHP Importation Services to learn how dicentra can support compliant Canadian market entry.