Rubina Surtie has found that she’ll have to follow strict quality and regulatory standards for natural health products if she wants to successfully build a sunflower oil processing business next year.
The Regina resident, along with a dozen other participants, attended the first of four workshops hosted by Ag-West Bio in Sask-atoon Sept. 20.
Surtie found it useful to learn about government regulations regarding facility design, calling it a stepping stone on the road to creating and developing her business.
She will next study the viability and feasibility of the plant, its implementation and start-up costs.
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“The information learned will be beneficial to that,” she said.
Ben Lee of FarmEng in Winnipeg, a pharmaceutical and natural health consulting firm, led the session and gave an overview of the importance of incorporating Good Manufacturing Practices, or GMP into facility designs.
“Understand the requirements and regulations and spend the time to plan your facility,” he said.
GMP describes the methods, equipment, facilities and controls required to produce finished products. Apart from being a good business practice, they are required under new regulations, he said.
Regulations covering natural health products came into effect in January 2004, with a list of rules under the Food and Drugs Act. For items to be sold in Canada as natural health products, they will require a product licence by January 2010.
Natural food products include herbal remedies, homeopathic medicines, vitamins and minerals, amino acids, essential fatty acids and probiotics, all intended for human use.
Lee said regulations regarding GMP protect the public but also give consumers confidence in the products produced and sold.
“It ensures the product on the shelf will meet the label claim,” he said, noting how a lack of regulations in the natural health industry had eroded public confidence by early 2000.
GMP strives to assure quality in the product by creating a highly trained workforce knowledgeable in the processes required to create it.
“Everything must be repeatable, so the tablet you produce will meet the label claim every time and so there are no surprises,” he said.
That includes clearly defined and systematically reviewed processes, appropriate resources from personnel to buildings, written procedures, trained operators, complete records and failure investigations, proper storage and distribution, complaint handling and recall systems.
He said having GMP in place will reduce the length of time needed for investigations or inspections.
Future workshops to be held across the Prairies will cover applications and renewal of site and product licences, safety and efficacy, packaging and labelling for natural health products and Generally Recognized As Safe approval in the United States.
Ag-West Bio works with government and private organizations to develop programming to help those in the functional foods and natural health products industry market their products. It created the seminars as part of the Canada West Program, funded by Agriculture Canada.
Krista Dennis of Ag-West Bio cited a number of Saskatchewan-grown products showing a lot of promise in the natural foods area. They include flax, whose lignans are recognized in preventing cancer, fenugreek to manage diabetes and borage oil for cell and skin health.
Lee said there are no compliance issues for growers, noting it is up to processors to ensure the raw materials they buy are in good order and processed according to government specifications.
He said failure to meet the new GMP requirements could result in the product being taken off the market, product recalls, damaged reputations, a loss of public confidence, sales declines and fines.
