Manufacturers Falling Behind on TPD Notifications and PMTA

by Chris Ford May 31, 2016

Our phones have been ringing off the hook with countless questions about TPD, diacetyl, PMTA, deadlines and general confusion. My Memorial Day weekend has been spent sorting through the issues and concerns faced by the many eliquids manufacturers I've spoken with over the past few months, while leisurely sampling a variety of flavors in my brand new mod (which I profess to know nothing about). In these conversations, I've seen a trend forming which suggests that eliquid and ecig manufacturers could be falling behind in preparing submissions, and many may miss deadlines.

If you haven't started preparing your product notifications, you could be dangerously behind schedule. Most manufacturers are focusing their efforts on testing and test requirements, but they skipped the most critical element of the notification - documented evidence that the process is repeatable and the product meets the product specification. Your starting point needs to look internally to your GMP practices, documented procedures, and records while you're evaluating your product distribution strategy.

I thought it might help to put this checklist together to clarify the timeline eliquids and ecig manufacturers should be following in order to meet the deadlines. I hope this answers some questions, but feel free to reach out if you need any help.

Today through August 1 -

• Finalize your list of products for the EU. Determine the countries you will distribute to, and verify your formulations. Reformulate as needed.
• Prepare all specifications including eliquid formulation, CAS numbers of components, bottle and cap, labeling, and packaging.
• Conduct a gap analysis then prepare manufacturing flow charts and your SOPs for production, equipment maintenance and calibration, clean room environmental controls, management oversight, employee training, product design, purchasing and supplier management, inspection and testing, acceptance criteria, process validation, complaint handling, corrective and preventive action, nonconforming materials, risk analysis, annual reporting, problem reporting and representative forms for each process. 
• Obtain your EU CEG Submitter ID from the European Commission and your FURLS establishment ID from FDA. 

NOTE: EU CEG Submitter ID may take a while. The sooner you request your ID, the better. The EC claims they're turning them around in a few days, but I've had some requests in for more than a week.

It's also extremely important that your descriptive documentation provide assurance that your manufacturing plant operates under GMP controls in order to demonstrate that you can repeatedly manufacture the product.

Great test results are meaningless, if you can't prove your processes can produce the same result every time.

If you can't show control over your processes, everything else that you submit will be meaningless. The European Commission isn't going to send an inspector to your site to verify you have the proper facilities and procedures in place, but the FDA will. The FDA will inspect tobacco product manufacturing establishments and audit procedures and records.

If you're not sure about what you need or if you need help with a gap analysis, feel free to give me a call. Chemular's Liquid Bones EU documentation set includes all of the SOPs you need to satisfy the EU's manufacturer obligations and the US FDA SOP requirements, as well as being fully ISO 9001 compliant. I strongly recommend this set to any manufacturer who hasn't implemented documented procedures and records that comply with US and EU requirements. 

You know your formulations and your processes, and you're confident in your test data. Don't let your SOPs and internal systems be your Achilles Tendon that kills your PMTA or TPD notification. There is too much at stake.

Chemular's Liquid Bones EU documentation set includes all of the SOPs and forms you will need to comply with the TPD and FDA requirements. When you implement Liquid Bones EU, you'll not only comply with international regulatory requirements, you'll be ready for ISO 9001 certification. A strong, GMP compliant quality management system will be the differentiator for eliquid and ecig manufacturing moving forward. 

You can purchase the entire Liquid Bones EU set here and receive 10% off between now and June 3, 2016. Use the coupon code VAPEON. You'll also receive a free update when we release additional procedures for US reporting and recalls, as well as a PMTA project plan to help guide you through the PMTA process.

August 1 through August 31 -

• Complete emissions toxicological and nicotine purity testing (minimum TPD requirements + any country-specific requirements).
• Conduct and document toxicological risk analysis that details the correlation of the product design attributes with public health risk
• Finalize list of products for US distribution
• Establish a FURLS account at FDA
• Allocate resources for each section of the PMTA

September 1 through September 30 -

• Reformulate if needed.
• Finalize all specifications.
• Assemble Technical Files for each product and write Declarations of Conformity.
• Prepare for submission of notifications.

October 1 through October 30 -

• Submit notifications on EU CEG
• Construct a plan and checklist for completing the PMTA
• Determine requirements for your environmental assessment
• Determine product stability requirements and develop a test plan 
• Construct your PMTA template
• Conduct US product verification and validation activities

November 1 through December 31 -

• Conduct literature review for clinical data
• Prepare all specifications including eliquid formulation, CAS numbers of components, bottle and cap, labeling, and packaging.
• Conduct a gap analysis for the PMTA GMP procedures then prepare manufacturing flow charts and your SOPs for production, equipment maintenance and calibration, clean room environmental controls, management oversight, employee training, product design, purchasing and supplier management, inspection and testing, acceptance criteria, process validation, complaint handling, corrective and preventive action, nonconforming materials, risk analysis, annual reporting, problem reporting and representative forms for each process. 

Purchase the entire Liquid Bones EU set here and receive 10% off between now and June 3, 2016. Use the coupon code VAPEON. You'll also receive a free update when we release additional procedures for US reporting and recalls, as well as a PMTA project plan to help guide you through the PMTA process.

• Register your establishment and list product on your FURLS account for US distribution.

January through December 2017 - (and beyond)

By January, you should have a solid project plan in place. If you're using Chemular's Liquid Bones EU SOPs and keeping records, you're already collecting the required information for reporting, and you've documented your manufacturing processes. You'll have adequate evidence which will demonstrate that you can manufacture product repeatedly.

All of the activities required by the PMTA regulations will take around 18 months to complete, so plan very carefully. The entire process is comprised of many inputs from a variety of sources and will require both internal and external resources. Many activities have dependancies Your final PMTA submission will be the sum of thousands of pages and around 1500 man hours to put it all together. These activities include:

• Risk based literature review
• Detailed description of components and methods
• GMP and Lab controls
• Manufacturing infrastructure 
• Determination of tobacco standards
• Environmental Assessment (plan, protocol and report)
• Review of research findings
• Identify chemical and physical identity of the products
• Conduct stability testing
• Conduct product analysis and description of manufacturing process (including validation)
• Identification of components, ingredients, additives, properties and principles
• Toxicology assessment and review and external testing
• Toxicological risk assessment
• Evaluation of human health impact
• Evaluation of consumer perceptions including use patterns and likelihood of irritation
• Actual Use Report
• Identification of human factors and abuse liability
• Identification of biomarkers of harm
• Health outcomes
• Sensory testing
• Postmarket surveillance

Chemular's regulatory team has already developed a PMTA project plan we're using internally. I'm converting it to a "manufacturer friendly" project plan that I'll include in the free update I'm sending out to purchasers of the Liquid Bones EU documentation set. 

Chris Ford
Director of Quality and Compliance Services
Chemular, Inc.

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