SGH Medical Pharma gains ISO 22000 certification
This is an international standard that “sets out the requirements for a food safety management system that can be certified to it”.
Why would a specialist in plastic consumables be interested in food safety? Because the Eskiss site manufactures primary packaging, such as the Unicadose®, and pill dispensers for nutraceuticals, which are classed as foods.
An obligation to achieve a specific result
Unlike certain frameworks, which are based on a “best endeavours” obligation, ISO standards are based on an obligation to achieve a specific result. Accordingly, the certification is synonymous with a quality expectation that is reproducible over time. For our regulatory experts, that means identifying food safety-related production risks so that the resources needed to control them can be managed over time.
Our quality department, which employs around 30 people, drew on its regulatory expertise to work on organising production and manufacturing procedures with the staff concerned, on the basis that quality is everyone’s business. The aim was to demonstrate our ability to manage risks and provide safe products that are suitable for their intended use. This includes, for example, regular analyses proving that there has been no migration of the packaging materials used into the product.
The devil is in the detail
However, the risk assessment did not only focus on the product. We’re told that the oil used in the machines, the neon lights and even the area surrounding the factory were included. Why? Because the composition of the oil must make it suitable for chance contact with food and the neon lights must be unbreakable. And the bushes around the factory must be impeccably trimmed so that they do not serve as a refuge for potential pests that could harm the products.
This is the first certification for the Eskiss site. We are also planning to submit its application for ISO 13485 certification this year. The aim is not only to produce medical devices but also, if necessary, form part of the business continuity plan for other SGH Medical Pharma sites.