WHERE KOMPETE WORKS
GMP is where we live. GxP is the neighbourhood.
Kompete’s quality and compliance work is centred on Good Manufacturing Practice: site licensing, quality systems, documentation, supplier qualification, stability programs, deviation handling and audit readiness for supplements, natural health products, foods, cosmetics and OTC products. That is the work we do directly, drawn from twenty years of building and defending these systems.
The wider GxP framework, Good Clinical Practice for trials, Good Laboratory Practice for non-clinical safety studies, and the emerging Good Machine Learning Practice principles for AI-enabled products, sits adjacent to that. Where a project needs those, we say so and bring in a specialist rather than improvising. Knowing the boundary is part of the service.
SCOPE
If it is consumed, injected, applied or implanted, GMP applies.
Different regulators, different regulations, same underlying expectation. These are the categories where a quality system is not optional.
PHARMACEUTICALS
Prescription and over the counter medicines, vaccines, and active pharmaceutical ingredients.
MEDICAL DEVICES
From surgical instruments and test kits to inhalers, syringes and implantable devices, under device-specific quality system regulations.
FOOD AND BEVERAGE
Processed foods, beverages and infant formula, where the standard rises sharply with the vulnerability of the consumer.
SUPPLEMENTS AND BIOLOGICS
Vitamins, minerals, botanicals, protein powders, probiotics and natural health products, under 21 CFR Part 111 in the United States and Part 3 of the Natural Health Products Regulations in Canada.
COSMETICS
Skincare, colour cosmetics and topical preparations, focused on purity, preservation and microbial control.
THE FRAMEWORK
Five pillars, and only one of them is the building.
GMP frameworks differ in wording between jurisdictions but organise around the same five areas. A gap in any one of them undermines the others.
01
People
Training records tied to specific procedures, not attendance sheets
Documented competency for every role that touches product
Hygiene practices and protective equipment requirements
Defined responsibilities and a quality unit independent of production
02
Premises
Facility layout designed to prevent cross contamination
Air handling and filtration appropriate to the product
Sanitation programs with continuous, dated records
Pest control and waste management
Segregation of materials by status: quarantined, released, rejected
03
Processes
Validated manufacturing steps that produce the same result batch to batch
Defined in-process controls with acceptance criteria
Equipment qualification and cleaning validation
Change control that assesses impact before the change is made
04
Procedures
Approved, dated, version-controlled standard operating procedures
Batch records signed by qualified personnel at each step
Good documentation practice, contemporaneous and attributable
Deviation and investigation procedures that get used, not just filed
05
Products
Raw material identity, purity and potency testing on receipt
Supplier qualification with documented review and ongoing verification
Finished product release testing against a written specification
Label and packaging component control and reconciliation
Recall procedure capable of tracing every unit of every lot
TWO DIFFERENT LICENCES
One approves the recipe. The other approves the kitchen.
The most common misunderstanding in Canadian NHP compliance is treating these as one thing. They are separate applications, assessed by different criteria, and both must be in place before a finished product can be sold.
Product licence
Issued as an NPN or DIN-HM
Approves the formula, the dose, the claims and the label
Assessed against monographs and submitted evidence
Held by the brand owner
Required for every SKU
Site licence
Approves the physical site and the activities conducted there
Required for manufacturing, packaging, labelling and importing
Assessed against Part 3 GMP requirements through a documentation package
Held by whoever performs the regulated activity
Subject to inspection
A brand that outsources production to a licensed contract manufacturer does not need its own site licence, but still needs the NPN and remains responsible for the marketed product. Bring any of those four activities in house and the obligation moves to you. One detail catches people out: storing finished product before sale is a regulated activity. Storing raw materials is not. Health Canada checks addresses against marketed products, and a warehouse arrangement is not neutral.
RECENT CHANGE
Foreign Site Reference Numbers are gone.
On February 16, 2026, Health Canada published Site Licensing and Good Manufacturing Practices Inspection Bulletin No. 10, ending the FSRN process with immediate effect and without prior notice to industry. The requirement to list foreign warehouses on site licences was removed at the same time.
WHAT ENDED
Foreign sites can no longer submit an FSRN authorisation form as GMP evidence. New applications are refused. Existing holders appear as discontinued on Health Canada’s published list.
WHAT REPLACED IT
Foreign site GMP evidence now goes through the standard site licensing pathway, submitted by the Canadian importer as part of its own application or amendment.
WHAT IT MEANS IN PRACTICE
Importers need full GMP evidence packages from each foreign manufacturer and packager. Where several importers rely on the same foreign site, the same evidence is submitted repeatedly.
WHAT IS UNRESOLVED
Health Canada has not updated the application forms or guidance documents, and the handling of confidential communications with foreign sites remains unclear.
Importers who relied on a partner’s FSRN to shorten their own application no longer have that option. Foreign site relationships now need documenting early, before the site licence application is prepared.
WHAT AN APPLICATION ACTUALLY CONTAINS
The form is short. The file is not.
A first-time site licence application is a substantial documentation exercise, commonly running to several hundred pages depending on the number of dosage forms and activities being licensed. Every element maps to a section of the GMP requirements, and each has to demonstrate that a system exists rather than describe one.
Quality manual and site master file
Standard operating procedure index with revision history
Organisational chart and personnel qualifications
Equipment list with cleaning and maintenance procedures
Stability protocol and supporting data
Supplier qualification procedure and approved supplier list
Sanitation program and cleaning records
Training matrix and individual training files
Complaint handling and recall procedures
Release testing specifications and methods
THE FOUR RECURRING GAPS
Rejections cluster in the same places.
These are not exotic requirements. They are the areas small operations defer early and have to retrofit under deadline.
STABILITY DOCUMENTATION
The single most common gap. Health Canada expects protocol-driven real time data on representative products, not a statement of intent to monitor stability. Studies that have not started before the application is filed will send the file back.
SUPPLIER QUALIFICATION
A two-line approved vendor list does not pass review. Every raw material supplier needs documented qualification covering certificate of analysis review, GMP status, audit history and identity verification on incoming lots.
SANITATION RECORD CONTINUITY
A cleaning log with gaps is worse than no log, because it demonstrates the system is not followed. Equipment used on a date with no corresponding cleaning entry gets flagged.
PERSONNEL TRAINING FILES
The area applicants most often believe is covered when it is not. A folder per employee with documented competency on every relevant procedure, retraining triggered by new procedures, and annual refreshers.
THE STRUCTURAL REQUIREMENT
The person who made it cannot release it.
A quality unit has to function independently of production. The individual who manufactured a batch cannot be the individual who approves its release. For small operations this is often the hardest requirement to satisfy, because it usually means hiring or contracting a quality lead specifically to break that conflict, before there is revenue to justify the position.
Every finished lot needs documented release testing against a written specification, with identity, purity and potency results on file before product ships. Outsourcing the testing to a contract laboratory is entirely acceptable. Outsourcing responsibility for reviewing and approving those results is not. Kompete can act as that independent review function where an internal appointment is not yet viable.
ENGAGEMENT MODEL
Four steps to a system that holds up.
01
Assess
We audit the current system against the applicable GMP requirements and produce a ranked list of findings, so you know what an inspector would raise before one does.
02
Build
We write the procedures, records, specifications and protocols, to the standard and to how the operation actually runs, because a procedure nobody follows is a finding rather than a control.
03
Implement
We support the training, the record-keeping habits and the quality unit structure that turn documentation into practice.
04
Defend
We prepare the application, manage the submission, respond to information requests, and support the inspection and any corrective action that follows.