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QAP SERVICES™
NHP Compliance provides QAP Services™ to a wide range of clients. A QAP is a Quality Assurance Person who is responsible for implementing and maintaining GMP to assure the quality of the NHP before it is made available for sale. This person must be qualified by education, training, or experience related to these activities.
We can set up your quality assurance department and/or assist your
quality personnel with implementation and/or maintenance of a
compliant system. Our services include:
- Regular product disposition (release)
- Handling communication and correspondence with Canada's Health Products and Food Branch Inspectorate (HPFBI; formerly known as TPP)
- Hosting HPFBI inspections
- Holding all sensitive documents and information (if desired)
- Preparing and maintaining Site Licence Applications (SLAs) and QA Reports(QARs)
- Evaluating GMP compliance of suppliers and subcontractors
- Coordinating product testing
If you are importing an NHP into Canada, you need to be compliant to
Health Canada’s Good Manufacturing Practices (GMPs). You must have:
- A quality assurance department
- Certificates of Analysis (C of A) for each lot or batch imported
- A set of standard operating procedures (SOPs) to manage the product importing under GMP requirements
- Regular product testing and lot disposition (release)
FAQs
- What do I need in order to import and distribute a Natural Health Product in Canada?
You need to obtain a Site Licence and the product you intend to market must have a Product Licence. All aspects of the regulations including GMPs and any commitments made in the PLA must be followed.
- What do I do if I am not able to test the active ingredient in my product?
If there is no known method of analysis, or other ingredients interfere with the analysis, it is acceptable to qualify by ‘input’
[See Evidence for Quality of Natural Health Products, June 2007 – Version 2 – 2.5.2.]
- Which products require testing for pesticides?
Pesticide residual testing is required for plant materials, algae, fungi, or non-human animal materials (e.g., fish or marine mammals) or extracts.
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