Under the proposed FDA regulations for the e-cigarette industry, manufacturers of e-cigarette products would be required to submit an application for each of their products and for every new product they plan to sell. The information required for these applications is similar to what would be included in a Master Batch Record:
- Full reports of all information known by the applicant of studies that show the health risk of tobacco products and whether this tobacco product presents less risk.
- Statement of all components, ingredients, additives, properties and principles of operation in creating the product.
- Full description of the methods, facilities, manufacturing process, packing and installation of the product.
- Identifying reference to any tobacco standard under section 907 to show that the product meets the full standards or provides adequate information to justify any deviation from these standards.
- Samples of the new product.
- Proposed labeling of the product.
- Other information as seen fit by the FDA.
Having access to this information in Master Batch Records and Batch Production Records are important components in Good Manufacturing Practices. Though it may seem daunting, having a manufacturing execution software like InstantGMP Vape can not only help you ease into compliance with upcoming FDA regulations, it also gives you a high-tech edge over the competition. Your e-liquid will always be consistent and of high-quality with InstantGMP Vape. Request a demo today!