Quality Management Methodology
The QUALITY MANAGEMENT section of CORE COMPLIANCE focuses on the types of systems that you have in place to ensure consistency of manufacture and quality. If you employ these steps you will begin to build genuinely robust processes and demonstrable due diligence, as well as meeting your regulatory obligations.
Sometimes referred to as a “Production file” for the notification process, a QMS (Quality Management System) is something that ensures you have a written process for all aspects of your manufacturing process. Your QMS does not currently need to be at an international standard, but will likely be in time, with GMP being the likely requirement for Europe.
Recording batch numbers on your products is only a small part of the entire batch recording process. You must have full batch records that detail which supplier concentrates were used, from which order number and to where they were shipped. The more robust your batch records the easier it is to demonstrate you could effect a product recall if required.
Batch testing comes in different forms but usually focuses on preset benchmarks around nicotine concentrations and emissions. Stability testing can also fall into this bracket, which is necessary to support your claims for the shelf life of your product. These tests should be proceduralised and documented
Tracking changes in all of your documentation is a good practise to follow. Whether it be recipes, mixing procedures or HR documents, implementing a versioning system will detail and record changes that will track with your regulatory requirements.
Making sure you have appropriate archiving and back up systems is a crucial part of any business, but none more so in a regulated environment. As with financial documents, regulatory documentation carries a requirement to hold for 6 years, and more in some cases.
An internal audit procedure doesn’t need to be overly complicated, simply enough to review all the benchmarks that you have put in place on a regular basis. This isn’t a regulatory obligation, but adds depth to your due diligence to support any investigation.
Product traceability isn’t a regulatory requirement for vape products at present, but the EU and UK will likely phase this in at some point so it would be wise to consider product tracking systems now, so that you are ready when the time comes.
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