Natural Health Product Quality Control/Quality Assurance

Natural Health Product Good Manufacturing Practices (NHP GMPs) are outlined in the NHP Regulations. The NHP GMPs are divided over four sections, each section of the NHP GMPs provides detailed guidance on Health Canada’s expectations for compliance.

1. Places
2. People
3. Processes
4. Products

"Places" covers premises and equipment and describes the requirements for ensuring that natural health products are not made or stored under conditions which could affect its quality.

"People" covers the requirements for personnel and quality assurance. Personnel appropriately trained by education and experience must be in charge of the Quality Assurance Department.

"Processes" covers the sanitation program and operations to ensure that procedures are in place to minimize adverse impacts on quality.

"Products" covers specifications, stability, samples, records, recall reporting, and sterile products.

Essentially, these sections of GMP have the purpose of ensuring that products are consistently manufactured to predetermined specifications and put controls in place for monitoring the effectiveness of the quality program.

A DSA NHP Consultant can assist you with any function of GMP Compliance. A DSA NHP GMP Consultant will work with you to ensure that our client's NHP shipments have met the requirements of the Canadian NHP GMPs. We can act as your QA/QC department (Quality Assurance Person or QAP) and review production documents and analytical test results to support product releases. If all documents are satisfactory, your NHP Consultant will promptly release products for sale in Canada. We can handle your product releases on a full-time, part-time, or on an as-needed basis to cover staff shortages due to vacation or other absences.

For clients that are new to GMP compliance requirements, our GMP Consultants will work with you to develop GMP programs including preparation of SOPs (Standard Operating Procedures). We will work with you to help prepare your staff and facility to pass a Quality Audit (Quality Assurance Report) and eventually a Health Protection and Food Branch Inspectorate GMP Inspection.

For more information on our NHP GMP Consulting Solutions, please contact us to find out more information. To find out more about marketing a healthcare product in Canada, please request a copy of our white paper.