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Bella Lucce's Quality Control Program
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1. Every ingredient is sampled and assigned a lot number as they are delivered to our warehouse. This lot number identifies several items, chief among them: the source of the material, date of delivery, pertinent order details and who/when/and why it cleared quality control. Furthermore, these raw materials are sampled and retained for 36 months in our warehouse.Though this type of training, sterilization and record keeping involves significant resources, fastidiousness and vigilance (not to mention an ungodly amount of patience), it is of paramount importance that we be totally confident in every product that bears the Bella Luccè name. We are are proud to be fully compliant with the Good Manufacturing Practices (cGMP), as set forth by the FDA. But what does that mean for you?
2. Batch Worksheets (which are the foundation of every batch) are clear and concise and contain not just the raw formulas, but all relevant information with regards to proper weighing and blending techniques, appropriate preservation data and sterilization protocol. This improves accuracy and eliminates confusion as every Bella Luccè product has its own formulation worksheet and protocol so that we can yield consistent, reproducible product.
3. These Batch Worksheets require that a multitude of production variables be recorded for every batch. These include the temperature readings of the batch at various stages, the name of the staff member creating the batch, the creation date and the lot number of every raw material used in the formulation.
4. We use a team approach when creating each and every Bella Luccè product. At least two team members must sign off on every ingredient added to the batch. This technique involves a significant time investment on behalf of the company, as every raw material is individually weighed and then cross-checked by a second team member, but it ensures the accuracy of each step along the way.
5. All Bella Luccè products bear a unique batch number and all batch samples are retained on-site for 36 months. Batch Worksheets are maintained for the same period of time.
6. Every hydrous product (those that contain water) is tested for potential contamination of mold, fungus, yeast and/or bacteria. A third-party production director (who was not involved in the production itself) performs microbial testing and we incubate the plates on-site in a temperature and humidity controlled incubator for maximum accuracy. No batch is released for distribution until we have a “clear” screen for all contaminants. The Microbial Testing Report and individual plates are retained in our offices for a period of 36 months.
7. Production team members are continually trained to expand and reinforce their knowledge. Topics include proper compounding technique, instrument sterilization, new product launch training, personal safety, material handling, equipment training and proper checks and balances. Individual, biannual reviews with each production team member ensure the highest quality production personnel with an impressive degree of quality group and individual training.
8. Our production team members work in a dedicated, controlled environment that is sealed off from our shipping, storage and office facilities to better control the purity of the environment. Team members must wash hands upon entering the production areas and- at all times- wear hair nets, shoe covers and nylon gloves to ensure the integrity of the products themselves. We are fastidious about the cleanliness of our production kitchens and have an exhaustive daily cleaning protocol that guarantees the proper production setting.
9. While the FDA does not approve cosmetic production facilities, it does request a voluntary registration with federal officials. Though it is estimated that less than 35% of all U.S.-based facilities have voluntarily registered, Bella Luccè is proud to be “on record” with the FDA (registration # E1002789).
10. Bella Luccè records the batch number of every outgoing product, whether it’s a single retail scrub headed towards Minnesota or a pallet of professional back bar crèmes bound for Dubai. This information is retained in our files so that, in the unlikely event that we ever have a product recall, we can track who-got-what-and-when to ensure the safety of everyone.