Quality Decision Tree

Robust Quality Management Systems

Are your eLiquids manufactured in an ISO 9001 accredited facility?

YesNo

Robust Quality Management Systems

Can you provide evidence of this?

BackYesNo

Robust Quality Management Systems

Great, we have noted this on your final report.

We will now move to section 2 of 4:
Compliance with the Tobacco Products Directive

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Robust Quality Management Systems

If you are ISO accredited yourselves then you can supply a copy of your ISO certificate as evidence. We will highlight this on your final report and a member of the team will be able to assist you. If it’s an external ISO accredited manufacturer who is unable to provide you with a copy of their certificate then we can help you by searching for the accreditation through BSI.

We will now move to section 2 of 4:
Compliance with the Tobacco Products Directive

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Robust Quality Management Systems

Can the production facility provide evidence of procedures, staff training and batch traceability?

BackYesNo

Robust Quality Management Systems

We can help you or your external manufacturer to put the relevant systems and quality procedures in place, most of which are pretty standard.

We will note this on the final report and will now move to section 2 of 4:
Compliance with the Tobacco Products Directive

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Compliance with the Tobacco Products Directive

Are your eLiquid products TPD compliant?

BackYesNo

Compliance with the Tobacco Products Directive

Can you provide evidence of this?

BackYesNo

Compliance with the Tobacco Products Directive

Great, we have noted this on your final report.

We will now move to section 3 of 4
Analytical Batch Testing

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Compliance with the Tobacco Products Directive

All TPD compliant products should have been submitted to the MHRA and so you will be able to provide evidence by tracking through your submitter ID number. We will note this on the final report and a member of our team will be able to assist you to provide the evidence.

We will now move to section 3 of 4
Analytical Batch Testing

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Compliance with the Tobacco Products Directive

Were your products on the market before the 20th of May 2016?

BackYesNo

Compliance with the Tobacco Products Directive

Any product which was not on the market before May 20th 2016 should be TPD compliant. You may not need to have performed any action or submission for such a product. We will note this on the final report and a member of our team will be able to assist you to determine the compliance of the product.

We will now move to section 3 of 4
Analytical Batch Testing

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Compliance with the Tobacco Products Directive

Are your products currently undergoing the TPD testing/submission process?

BackYesNo

Compliance with the Tobacco Products Directive

Because your product was on the market prior to May 20th 2016 you have a six month grace period to November 20th 2016 to get the product ready for compliance. Following November 20th any non-compliant product may no longer be imported or manufactured. We will note this on the final report and a member of our team will be able to talk you through the implications and options.

We will now move to section 3 of 4
Analytical Batch Testing

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Compliance with the Tobacco Products Directive

Can you provide evidence of this?

BackYesNo

Compliance with the Tobacco Products Directive

Evidence may consist of a statement from your TPD supplier confirming that your TPD testing is in progress and that it will be reported by the deadline in November. We will note this on the report and a member of our team will be able to assist you to request the appropriate evidence. We will now move to section 3 of 4 - Analytical Batch Testing

We will now move to section 3 of 4
Analytical Batch Testing

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Analytical Batch Testing

Are your eLiquids batch tested?

BackYesNo

Analytical Batch Testing

Can you provide evidence of this?

BackYesNo

Analytical Batch Testing

The analytical reports themselves offer a good evidence. If your supplier is unable to provide these for each batch then we can request them for you. We will note this on the final report and a member of the team will be able to assist you to gather the required evidence.

We will now proceed to the final section:
Toxicological Risk Assessment

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Analytical Batch Testing

Do your eLiquids contain any chemicals on the exclusion list?

BackYesNoUnknown

Analytical Batch Testing

We can assist you to understand your analytical reports along with any relevant implications and are then able to assist where you may have unwanted levels of specific chemicals or to advise you which compounds you should be looking for. We will add this to the final report and a member of our team will be able to advise how best to proceed.

We will now proceed to the final section:
Toxicological Risk Assessment

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Analytical Batch Testing

Certain chemicals should be minimised in eliquid. We can help you to remove or reduce specific chemicals through our Flavour Laboratory or help you to perform an entry point audit for any unwanted chemicals in your production process. We will note this on the final report and a member of our team will be able to discuss your specific requirements.

We will now proceed to the final section:
Toxicological Risk Assessment

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Analytical Batch Testing

Can you provide evidence of this?

BackYesNo

Analytical Batch Testing

Great, we have noted this on your final report.

We will now proceed to the final section:
Toxicological Risk Assessment

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Analytical Batch Testing

Have you performed any analytical testing on your eLiquid products?

BackYesNo

Analytical Batch Testing

eLiquid analysis is a vital part of your quality system and your ability to demonstrate product safety. It isn’t expensive and adds a lot of confidence in your product both for both yourself and the end user. We can help you with a whole range of analysis and show you why it’s so important. We will note this on the final report and a member of the team will be able to take you through the process.

We will now proceed to the final section:
Toxicological Risk Assessment

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Analytical Batch Testing

Can you provide evidence of this and justification for not performing batch testing?

BackYesNo

Analytical Batch Testing

In order to remove the need to test every batch of eLiquid you manufacture you should have a robust set of underlying data supporting your decision. Without this data set its very difficult to justify the lack of analysis and to have confidence in your product. We can help you with a whole range of analysis and show you why it’s so important. We will note this on the final report and a member of the team will be able to take you through the process.

We will now proceed to the final section:
Toxicological Risk Assessment

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Analytical Batch Testing

Do your eLiquids contain any chemicals on the exclusion list?

BackYesNoUnknown

Analytical Batch Testing

Because there is the potential to breach the thresholds of unwanted chemicals it is very important to ensure that you have a robust quality system in place either through constant batch testing or by outlining and statistically establishing a high level of confidence that your process are sufficiently controlled to ensure that the unwanted chemical will never breach the thresholds. We will note this on the final report and a member of the team will be able to take you through this process.

We will now proceed to the final section:
Toxicological Risk Assessment

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Analytical Batch Testing

Can you provide evidence of this?

BackYesNo

Toxicological Risk Assessment

Do you have documented toxicological assessment of your products?

BackYesNo

Toxicological Risk Assessment

A full Toxicological Risk Assessment performed by a registered Toxicologist is essential to ensuring that your product is as safe as possible for the end user when used over a prolonged period of time. We will note this on the final report and a member of our team will be able to assist you to commission the correct Toxicological Assessments.

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Toxicological Risk Assessment

Can you provide evidence of this?

BackYesNo

Toxicological Risk Assessment

Your Toxicologist should have provided you with an assessment report or your manufacturer should be able to provide you with a confirmation that the reports exist. We are able to request these on your behalf. We have noted this on the final report.

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Toxicological Risk Assessment

Was this assessment performed by a registered toxicologist?

BackYesNo

Toxicological Risk Assessment

It's not a legal requirement to use a registered Toxicologist but it is highly recommended and as set out in the British Standard for electronic cigarettes PAS 54115. We are able to review the level of toxicological data you have at present and offer advice and solutions should it require further work. This will be noted on your final report and a member of the team will be able to take you through the assessment investigation.

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Toxicological Risk Assessment

Can you provide evidence of this?

BackYesNo

Toxicological Risk Assessment

Great, we have noted this on your final report.

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Toxicological Risk Assessment

Your Toxicologist should be able to provide you with evidence of their registered status. You should request this from themselves. If this is prooving difficult then we can request this on your behalf and also search the register to ensure they are compliant. This will be noted on your final report and a member of the team will be able to take you through the assessment investigation.

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Your Report

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