How does Health Canada assess the Quality Assurance Person and Third Party Auditor?
The Quality Assurance Person and Third Party Auditor are assessed according to the requirements set out in Sections 47 and 51 of the Natural Health Products Regulations (see question 1 above). Further information and guidance on these requirements are found in Chapter 3 (Supplementary Personnel Requirements) of the Good Manufacturing Practices Guidance Document for Natural Health Products. Please refer to the following link: Good Manufacturing Practices Guidance Document or contact the Natural Health Products Directorate at 1-888-774-5555 for a copy of the document. The Quality Assurance Person and Third Party Auditor are also assessed against the specific activities (e.g., manufacturing, packaging, labelling etc.) and products (e.g., sterile or non sterile, homeopathic medicines) as stated in the site licence submission.
Related Questions
- Will Health Canada accept a Third Party Auditor as an in-house Quality Assurance Person for a number of natural health product companies?
- Will Health Canada recognize a Third Party Auditor as an in-house Quality Assurance Person for a natural health product company?
- How does Health Canada assess the Quality Assurance Person and Third Party Auditor?
