Who is responsible for ensuring that the Quality Assurance Person and Third Party Auditor meet the regulatory requirements?
All Manufacturers, Packagers, Labellers and Importers of Natural Health Products are responsible for ensuring that their Quality Assurance Persons and Third Party Auditors are qualified under Sections 47 and 51 of the Natural Health Products Regulations. Section 47 states “Every natural health product shall be manufactured, packaged, labelled and stored by personnel who are qualified by education, training or experience to perform their respective tasks.” Section 51(1) states • “Every manufacturer, packager, labeller, importer and distributor shall • have a quality assurance person who • is responsible for assuring the quality of the natural health product before it is made available for sale, and • has the training, experience and technical knowledge relating to the activity conducted and the requirements of this Part; and • investigate and record every complaint received in respect of the quality of the natural health product and, if necessary, take corrective action”.
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?
- Who is responsible for ensuring that the Quality Assurance Person and Third Party Auditor meet the regulatory requirements?
- How does Health Canada assess the Quality Assurance Person and Third Party Auditor?
