Good Manufacturing Practices (GMPs) establish the controls necessary to help ensure Natural Health Products (NHPs) are consistently manufactured, packaged, labelled, imported, distributed and stored in a manner that supports product quality. For Canadian importers, GMP compliance extends beyond confirming that a foreign manufacturer operates under an appropriate quality system, as importers have responsibilities related to product specifications, quality assurance, finished-product release, stability, documentation, storage, distribution, complaints, recalls and oversight of activities performed outside Canada.
Health Canada’s updated Good Manufacturing Practices Guide for Natural Health Products (GUI-0158), Version 4 came into effect on March 4, 2026, providing additional clarification regarding a number of GMP expectations, including those applicable to importers. The transition to the updated guidance provides an important opportunity for Site Licence Holders to assess whether their procedures, records, quality agreements and personnel training remain aligned with Health Canada’s current expectations.
Recent NHP inspections have identified deficiencies involving training, finished-product specifications, testing, stability programs, documentation, sanitation, equipment, SOPs and recall procedures. Recent recalls have also involved issues ranging from undeclared ingredients and incorrect label claims to packaging defects, illustrating the range of product-quality issues that an effective NHP quality system must be capable of preventing, identifying, investigating and addressing.
For importers, effective GMP implementation therefore requires more than obtaining documentation from a foreign supplier. It requires an operating quality system supported by appropriate oversight, documented procedures, reliable records and personnel who understand both their responsibilities and how those responsibilities fit within the broader Canadian NHP regulatory framework.
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Part 3 of the Natural Health Products Regulations establishes GMP requirements applicable to the manufacture, packaging, labelling, importation, distribution and storage of NHPs sold in Canada. Health Canada’s GMP guidance provides further information regarding how these requirements can be met and how regulated parties can demonstrate compliance.
For importers, one of the most important principles is that activities performed by a foreign manufacturer do not eliminate the importer’s responsibilities in Canada. The importer requires appropriate controls to ensure that products brought into Canada comply with their established specifications and applicable regulatory requirements before they are released for sale.
Depending on the product and supply chain, these responsibilities can involve finished-product specifications and testing, Certificates of Analysis and supporting documentation, product release, foreign manufacturing documentation, Quality Assurance Person (QAP) responsibilities, stability and expiry-date support, transportation and storage, deviations and out-of-specification results, complaints and investigations, corrective and preventive actions, recordkeeping, traceability and recall procedures.
The extent of an importer’s direct involvement in individual activities may vary according to the product, foreign manufacturer, contractual arrangements and quality system. However, where activities are performed by another party, the importer still requires appropriate processes for oversight and access to the information necessary to demonstrate that the NHPs it imports meet applicable Canadian requirements.
An NHP GMP inspection can extend across the systems, procedures, records and activities used to demonstrate compliance with Part 3 of the Natural Health Products Regulations. For an importer, an inspection may therefore examine considerably more than whether the organization holds an appropriate Site Licence or has collected documentation from its foreign suppliers.
Inspectors may examine how the importer evaluates and releases finished products, how quality responsibilities are assigned, whether required records are maintained or accessible, how foreign activities are overseen and whether written procedures accurately reflect what occurs in practice. The assessment may also consider whether the QAP has appropriate authority and qualifications, whether personnel have received training relevant to their responsibilities and whether quality decisions are appropriately supported and documented.
Where manufacturing, packaging, labelling, testing, warehousing or other activities are performed by third parties, the importer may need to demonstrate how those activities are controlled and how relevant quality information is obtained, reviewed and acted upon. Written procedures establish how regulated activities are intended to be performed, while records and other quality documentation provide evidence that those procedures have been consistently implemented.
Finished-Product Specifications and Release
Finished-product specifications establish the requirements against which an NHP is evaluated, and the QAP is responsible for ensuring that each imported lot is assessed against the applicable finished-product specifications and Canadian regulatory requirements before release, using appropriate test results, Certificates of Analysis and other supporting documentation. This assessment can involve test results, Certificates of Analysis, batch documentation and other information relevant to the product’s identity, purity, quantity, potency and overall quality.
During an inspection, Health Canada may therefore examine whether appropriate specifications are available, whether required testing has been completed and whether release decisions are supported by adequate documentation. Recent inspection observations have included deficiencies involving finished-product specifications, inadequate testing and quality-assurance procedures that did not adequately address the assessment of products or materials before release.
Quality Assurance
Quality assurance connects individual GMP activities into a functioning quality system, with the QAP responsible for a number of activities affecting product quality, including product release and the assessment of quality issues. For importers, these responsibilities can require the evaluation of information generated by foreign manufacturers, laboratories and other parties operating outside Canada.
Although an importer may rely on manufacturing or testing activities performed elsewhere, its quality system should establish how that information is reviewed and how the organization determines that applicable Canadian requirements have been met. Quality procedures should also appropriately address deviations, out-of-specification or out-of-trend results, complaints, returned products, investigations and corrective and preventive actions so that quality issues are consistently identified, evaluated and resolved.
Stability and Expiry Dating
Stability provides evidence that an NHP will continue to meet its specifications throughout its stated shelf life when stored under the recommended conditions. Manufacturers and importers have responsibilities related to determining and supporting the period during which the product maintains its required characteristics and medicinal ingredient quantity or potency.
For imported products, the underlying stability studies may have been conducted by a foreign manufacturer, but the importer still requires appropriate access to the information necessary to support the Canadian product’s expiry date and evaluate whether the available stability program meets applicable requirements. Recent inspection findings involving inadequate stability programs and failure to follow established stability procedures or protocols demonstrate why expiry dating must be supported by an appropriate program and evidence rather than treated solely as information printed on the finished product.
Documentation and Records
Documentation provides the evidence necessary to demonstrate that GMP activities occurred as required. Although importers may not necessarily maintain every record generated by a foreign manufacturer at their own facility, applicable records must either be maintained or remain accessible in accordance with the relevant requirements.
Depending on the operation, documentation can include product specifications, Certificates of Analysis, manufacturing information, product-release records, stability documentation, SOPs, quality agreements, complaints, investigations, CAPA records, distribution information and training records. These records should provide reliable, complete, consistent and accurate information regarding regulated activities, particularly where they support product release or another quality decision.
Recent inspections have identified deficiencies involving incomplete records, inadequate electronic documentation systems and procedures that did not adequately address record maintenance. These findings demonstrate the importance of treating documentation as part of the quality system itself rather than simply as material assembled in preparation for an inspection.
Recall and Traceability
Every manufacturer, packager, labeller, importer and distributor must establish and maintain a system capable of permitting the rapid and complete recall of affected lots or batches made available for sale. For importers, effective recall capability depends on appropriate traceability through the Canadian distribution system and access to the information required to identify affected product.
Recall procedures should establish how affected lots will be identified, how distribution will be traced, how relevant parties will be notified and how the recall will be documented and managed. Mock recalls can provide an opportunity to evaluate whether those procedures function as intended before an actual recall is required, while distribution records and supporting documentation provide evidence that the organization can execute the process when necessary.
Personnel and Training
NHP GMP systems depend on personnel being qualified to perform their assigned responsibilities and understand the requirements applicable to the work they perform. This includes appropriate education, training and experience, clearly defined roles and responsibilities, and a documented training program that reflects the activities personnel perform within the quality system.
Training becomes particularly important when regulatory guidance, SOPs, equipment or processes change because personnel must be able to apply updated requirements within their day-to-day responsibilities. Training records should therefore demonstrate not only that an individual completed training, but that the training was relevant to the responsibilities associated with that person’s role.
Health Canada inspection reports have identified inadequate training records, training that did not reflect personnel responsibilities and deficiencies in written training programs. These findings reinforce the role of training as an integral GMP control that supports consistent execution of procedures, informed quality decisions and the organization’s ability to demonstrate that personnel are qualified for the activities they perform.
GMP deficiencies do not necessarily involve the complete absence of a quality system, as weaknesses can develop at individual points within an otherwise established program. A specification may be incomplete, required testing may not be performed according to the approved specification, a QAP may lack sufficient documentation to support a release decision, an investigation may fail to adequately address an out-of-specification result, or a stability protocol may exist without being consistently followed.
Similar weaknesses can be identified through documentation and operational records. SOPs may no longer reflect current practices, training records may not demonstrate that employees were appropriately trained for their assigned responsibilities, equipment maintenance or calibration records may be incomplete, or recall procedures may not contain sufficient detail to support rapid execution.
Published Health Canada inspection reports issued after the March 4, 2026 transition date provide practical examples of the areas receiving attention during inspections. Observations have included issues involving specifications, premises, equipment, sanitation, operations, quality assurance, stability, records, retained samples, personnel training and recall procedures.
An inspection observation should not automatically be interpreted as a non-compliant rating, as Health Canada evaluates the nature and significance of the observations, the establishment’s response and other relevant factors when determining the overall inspection outcome. Nevertheless, published inspection findings provide useful insight into the systems, records and activities organizations should be prepared to demonstrate during regulatory oversight.
Recall activity provides another perspective on the types of quality issues that can affect NHPs after they reach the Canadian market. Recent 2026 recalls have included an NHP containing an undeclared active ingredient, products with defective tamper-evident seals and a probiotic product with an incorrect “No Dairy” claim despite containing bovine colostrum.
These recalls involve different aspects of product quality and should not, by themselves, be interpreted as evidence of GMP deficiencies at the affected companies. They do, however, illustrate why controls must operate across the product lifecycle, from specifications, testing and packaging through labelling, release, distribution, complaint handling, traceability and recall.
For importers relying on foreign manufacturing and testing activities, the effectiveness of these controls also depends on the ability to obtain, understand and evaluate information generated elsewhere in the supply chain. An importer should therefore consider not only whether its foreign partners have appropriate quality systems, but whether its own Canadian quality system provides the oversight, documentation and decision-making processes necessary to fulfil its regulatory responsibilities.
NHP GMP compliance involves interconnected responsibilities across quality assurance, specifications, operations, sanitation, stability, documentation, storage, distribution and recall. Personnel require sufficient knowledge of the requirements relevant to their activities as well as an understanding of how those activities affect other elements of the quality system.
A QAP responsible for imported product release, for example, needs sufficient knowledge to evaluate specifications, testing and supporting documentation and determine whether a lot can be released. Personnel responsible for documentation need to understand how records should be created, maintained and corrected, while employees involved in complaints, deviations or investigations need to understand how these events are documented, evaluated and escalated.
Importer personnel also need to understand how responsibilities are divided between the Canadian importer and foreign parties performing manufacturing, packaging, labelling or testing activities. Effective GMP training should therefore address both the requirements themselves and their practical application within an operating quality system, allowing personnel to understand why procedures exist, how they should be implemented and what evidence is required to demonstrate compliance.
With Version 4 of Health Canada’s NHP GMP guidance now in effect, organizations should consider whether their existing training remains aligned with current expectations and whether personnel responsible for GMP activities have received appropriate training on changes relevant to their roles.
dicentra’s Natural Health Product GMP Training provides a structured examination of the requirements that support an effective NHP GMP quality system. Based on Health Canada’s latest NHP GMP guidance, the program is designed for current and prospective Site Licence Holders, new employees and experienced professionals requiring updated GMP training.
The curriculum examines GMP requirements across the Natural Health Products Regulations, including specifications, premises, equipment, personnel, sanitation, operations, quality assurance, stability, records and lot or batch samples. For organizations importing NHPs, the training also examines how these requirements apply to importer activities, including product release, testing oversight, foreign manufacturing documentation, quality agreements, stability, record access and recall responsibilities.
Participants examine both regulatory requirements and their practical implementation, helping personnel understand how individual GMP activities contribute to the broader quality system. Following completion of the training and assessment, participants receive a unique serial-ID training certificate that can form part of the organization’s documented training records.
Learn more about dicentra’s Natural Health Product GMP Training and how it can support ongoing GMP implementation and inspection readiness.
Effective NHP GMP compliance depends on multiple systems operating together. Specifications establish what the product must meet, testing provides evidence against those requirements, quality assurance evaluates the information and controls product release, stability supports the assigned shelf life, documentation provides evidence that required activities occurred, and traceability and recall systems support an appropriate response when problems are identified.
For importers, these systems frequently extend beyond the Canadian operation because manufacturing, packaging, testing and other activities may occur at foreign sites. The use of foreign suppliers or service providers does not remove the need for appropriate Canadian oversight, making access to quality information, clearly defined responsibilities and personnel capable of evaluating that information essential components of the importer’s GMP system.
The March 4, 2026 implementation of Health Canada’s updated NHP GMP guidance provides an appropriate opportunity for importers to review whether their procedures, documentation, quality agreements and training remain aligned with current expectations. An effective GMP system should operate continuously rather than primarily in preparation for a Site Licence application or inspection, with qualified personnel, appropriate oversight and reliable records providing the foundation for demonstrating ongoing compliance.