Lucky Break Consulting has developed this comprehensive program, intricately detailing the path to implementation for cosmetic and personal care manufacturers. Based on Lela Barker’s decade of experience manufacturing products for her Bella Lucce brand, it simplifies each regulation and teaches, in words and pictures, how even the smallest of companies can be fully compliant.
This virtual class includes:
• 390 digital slides detailing every aspect of GMP compliance
• 98 behind-the-scenes photos from Bella Lucce, illustrating practical GMP protocols implemented on a shoestring budget
• 31 separate digital handouts (think: resource lists, shopping lists, sample forms, templates, checklists, logs, etc.)
• Recordings of our past live audio support calls.
You must use a customer account when you purchase this item. Using the anoymous option will not allow you to access your digital goods. Once your payment has been processed, you will receive an email with instructions on how to access the handouts and within 1 or 2 business days you will receive a password and link to access the slide presentation.
You’ll learn the exact criteria FDA inspectors are examining when inspecting a facility, fifteen specific tips for making home manufacturing environments GMP-compliant and seven amazing benefits enjoyed by GMP-compliant manufacturer. The class explores GMP regulations from start to finish and is accompanied by a twelve-month road map to implementation. Since the program is delivered virtually, you can study at your own pace and revisit the curriculum again and again as needed.
Building your company on a solid GMP foundation will not only ensure compliance to federal regulations, it will increase your confidence, encourage production efficiencies and position your company for growth and expansion!
What would happen if you received a call like this?
“My name is John Smith. My wife purchased your eye makeup remover at our local spa, but she had a really bad reaction when she applied it as directed. I've driven her to hospital and she's being examined at the moment. Her eyes are red, swollen and painful and she's having visual disturbances. I need all the information you can send me about that product ASAP.”
What could you provide John?
• You could certainly send him all of your company's contact information.
• You could probably send him an invoice showing when the product was sold to the spa, provided that John could tell you where his wife made the purchase.
• You really should be able to send him a complete listing of every ingredient in the product (I'm assuming your ingredient label is complete and accurate, yes?)
But could you tell him…
• The date on which that particular bottle of eye makeup remover was made by your company?
• The name of the individual who manufactured that exact bottle?
• The origin of every single ingredient that was used in the formula (which supplier provided that ingredient, when it was received by your company and the related documentation that shows it met your quality standards?)
You could if you were GMP compliant! And both his lawyer and the FDA would expect you to be able to provide every last bit of that information.
Good Manufacturing Practices (GMP) are a set of a parameters designed by the FDA as a part of their regulatory responsibility to safeguard public health by ensuring that the cosmetics and personal care products consumed by US citizens are of a high quality. While the federal government is not in the practice of designing the actual production systems, they do address the end results. In other words; the government allows manufacturers to design a personalized program of quality and control. However, the products ultimately released into the marketplace must meet certain specifications.
The good news is: the FDA isn’t going to tell you precisely how to fill a bottle of lotion without contaminating it, though they do mandate that your bottle of lotion cannot become contaminated during the fill process. The bad news is: there’s no government-issued handbook to detail precisely how GMP manufacturing should be performed for micromanufacturers operating from their homes or small commercial facilities.
Once you take the GMP - Good Manufacturing Master Class and use the resources Lela has created you will be able to confidently make safe products and be ready for any surprise phone call or visit.