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Thursday, November 7, 2013

Steps to Successful Product Formulation


The trade magazine, Natural Products Insider (NPI), recently published a slide show entitled, “Formulating Successful Products in Six Steps”.  While the presentation focuses on the development of dietary supplement products, similar considerations are helpful for cosmetic and food products as well.
The steps were written for brand owners using contract manufacturers but also apply to companies doing in-house manufacturing.

The first step cited was to set finished product specifications.  Specifications define the parameters for identity, purity, strength, and composition for the product.  Good Manufacturing Practices require setting specifications to guide the manufacture of the product.  You must set product specifications and also have procedures in place to verify that the product is being manufactured to those specifications.   

The slide show contemplates a scenario where the brand owner seeks help from the contract manufacturer’s formulator.  It is important that your contract with your manufacturer clearly states who owns the formula if you do use that service. 

According to the NPI slides the minimum specifications include but are not limited to information to:
1.      Define the purpose or benefit of the product.
2.      Determine the form of the product -- for supplements is it tablets, capsules, a powder?  For cosmetics it is a gel, lotion or cream?
3.      Determine what ingredients will be used. 
a.      I’d like to add that it is important to think about the availability of the ingredient and understand whether there are any seasonal pressures on the ingredient availability.  If you have an ingredient that is in short supply during certain seasons, consider formulating with a mixture of the preferred ingredient and its best substitute to stretch the supply and avoid sourcing issues.
b.      It is also very important to write specifications for whether ingredient substitutions may be made.  It is also important to clearly define what ingredients would be acceptable substitutions since these changes to the formulation can affect manufacturing, product quality as well as labeling and claims.
4.      Plan in advance which countries the product will be sold in and be aware of regulations or restrictions that affect which ingredients may be used.
5.      Determine whether some ingredients will be required or prohibited. Desired label claims such as ‘natural’, ‘low fat’, ‘vegetarian’ or ‘gluten free’.  Such claims will affect costs and may affect which manufacturers will be able to make your product. The claims that may appear on the final product label are determined by the formulation.

My associates and I can help you write specifications for your product.  We can also help you research the regulatory status of proposed ingredients and review product labels and marketing materials for compliance with FDA regulations.  We welcome your questions.

I hope that you will find this information helpful. Please use this link to subscribe to our occasional email newsletters regarding FDA regulations and other topics of interest to FDA-regulated companies.  We send messages targeted to the dietary supplement, cosmetic, food, OTC drug and medical device industry sectors.  You may subscribe to one or all of the newsletters and you may unsubscribe at any time.

Evelyn and Associates
Bioscience Translation & Application                                                 


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