GMP Compliance

NHP GMPs are similar to the Drug GMPs and are divided over four sections; places, people, processes, and 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 place controls in place for monitoring the effectiveness of the quality program.

DSA can assist you with any function of GMP Compliance. Typically, we 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) and review production documents and analytical test results to support product releases. If all documents are satisfactory, we 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, we 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.

Contact us for more information on how DSA can help you implement GMP compliant programs for your company. Or click here for more information on other services offered.

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