One of the big questions in this fast developing area is what standards should be used for e-cigarette products- both product standards and manufacturing standards. Clearly, e-cigarette liquids must have the right level of nicotine, not contain any impurities which may be harmful, be well characterised and be safe to use, but just as importantly, manufacturing must have the right systems and controls to ensure, that users have access to a safe and consistent product, and innovative products are introduced as rapidly as possible, in a controlled way.
There are many different manufacturing quality standards in existence at present including ISO9001, ISO13485, Food Standards (such as BRC and IFS) and Pharmaceutical Standards. Our belief is that e-cigarettes have their own unique opportunities and challenges and it is most appropriate to use the best parts of each standard to create a unique standard for our industry. In our own manufacturing facility, we are ensuring that the facilities meet high standards for cleanliness, all materials are well controlled, production equipment is fully validated to produce a high quality product, and we have a full range of validated analytical equipment to ensure we understand all aspects of our materials, products and processes. As the market evolves, we strive to continually improve all aspects of what we do.
A number of initiatives are ongoing across Europe and the rest of the world to bring appropriate controls to this area. The most recent Tobacco Products Directive includes overview requirements for electronic cigarettes, which are expected to be implemented across Europe. The British Standards Institution is working with regulators and industry to draft e-cigarette standards and the UK MHRA has an approval mechanism for e-cigarettes containing higher levels of nicotine, and those making health claims. Similar activities are in place in Europe and the rest of the world.
We are starting to work with key players within the industry, and regulators, to ensure that we can use our skills and expertise to introduce manufacturing standards that guarantee product quality without adding unnecessary costs. By doing this, we can focus on improving public health and ensure we do not place users at risk due to inadequate safety, quality or efficacy.
If you’d like to find out more about quality standards then feel free to give me a call or drop me an email. It’s just one of the many things myself and the team are passionate about so we’d love to chat more.
Jan Barrack, CQP,
Nerudia Quality Manager