Firstly thank you to everyone for their comments and thoughts on this topic.
This topic has been of interest to us as it was raised by an auditor as we didn't have anything specifically written into our GMP procedure about e-cigarettes at that time.
To date it hadn't been something we had thought to specifically define as we had incorrectly assumed the use of these devices was covered under our smoking section within our GMP procedure and employee induction information.
We do not permit smoking within our facility including GMP and Non-GMP zones however in accordance with our state and federal laws we do currently permit smoking in a DOSA (designated outdoor smoking area) which is compliant with both our GMP and general health & safety regulations. This has been working to date with no issues with smoking in any other area of our facilities or outdoor areas.
The main issue is understanding if the use of e-cigarettes and vaping devices are in fact classified as smoking and hence if they should have been treated as such. We have also since discovered that our state government has some regulations in place that cover off on both e-cigarettes and vaping anyway so this would help in the case of someone challenging a complete ban on the use of these devces on our site.
We have amended our GMP procedure to cover off on e-cigarettes, vaping and chewing tobacco as per below:
8.7.1 At all times smoking is prohibited in GMP Compliant and Non-GMP Compliant Zones including non-designated outside areas unless otherwise permitted in accordance with 8.7.3.
8.7.2 The use of e-cigarettes, vaping devices and chewing tobacco is not permitted on our site at any time.
8.7.3 Employees, Contractors and Visitors may only smoke cigarettes outside the factory premises in the designated outdoor smoking area (DOSA) or outside of the external property boundary lines.
8.7.4 Cigarette butts must be fully extinguished before being disposed in the receptacles provided.
8.7.5 No food or drink is to be consumed in the smoking area.