Specification Sheets

According to GMP guidelines^1,2, all raw materials purchased should meet defined acceptance criteria.

A Specification Sheet contains the exact, detailed acceptance criteria that an ingredient must meet in order to be used. You use them as a reference when purchasing items and as the basis for evaluating the item's quality when it is received.

You absolutely need Specification Sheets for ingredients. You can (and should) also use them for other materials and items that you purchase, such as:

• label stock/ink for different products
• containers and closures
• equipment (such as scales, mixers, molds or cutters)
• cleaning supplies
• production supplies (such as measuring cups, mixing pots, spoons/stirrers)
• packing/shipping materials

Format

Develop a standard format that you can use for all your Specification Sheets. Once you have a standard format, It is relatively easy to use a template to create a new document in the same format.

Content

The content of the Specification Sheet contains the detailed specifications, including:

Item Name: The name you use internally to reference the item. It should be unique.

Examples:

• Olive Oil – Virgin
• Olive Oil - Pomace
• Tapioca Starch
• Lavender 40/42 Essential Oil
• 2 oz blue PET Cosmo bottle
• 24/410 black pump

Item Number (optional): A unique identifying number for that item or ingredient.

Description: A simple description of the item with enough details to identify that item, including any unique color, flavor, or odor characteristics. You should include the Latin scientific names for botanical items to ensure the correct plant is being used.

Examples:

• Finely ground tapioca (Manihot esculenta) root. A white powder with a silky feel. No to minor cereal-like odor.
• Natural cocoa (Theobroma cacao) seed butter. Light to medium tan color, faint to strong cocoa-like scent. Solid and hard at room temperature.

Detailed Criteria: Detailed specifications for the item, including any critical, major, and minor specifications.

Components: The components and percentages should be listed on the specification sheet if the item is a blended ingredient, such as a lotion or soap base. When you have the components, you can tell if the supplier has changed the formulation or if the product you are getting from a different supplier is the same.

Name for ingredient declaration: If it is an ingredient for a cosmetic product, list the correct name for the ingredient declaration. The name for the ingredient declaration may be different than the name you use to reference the item. For a blended ingredient, list the correct name for EACH of the components identified above.

Approved Suppliers: A list of suppliers you have vetted and who can – or should be able to —provide the product or items at the required specifications. You should include each supplier's basic contact information and the product number they use for the item.

Verification Checklist

You should create a Verification Checklist based on the Specification Sheet.

Records

Keep your Specification Sheets where you can find them when needed. A binder or file folders would be sufficient if they are on paper. If they are digital, set up a file naming system so you can easily find them.

A log book or Excel spreadsheet listing all your Specification Sheets might help keep them organized and easy to find.

Safety Substantiation

For cosmetic products, Specification Sheets and Verification Checklists for the ingredients in the product are part of your safety substantiation.

With the Specification Sheet, you set the requirements and specifications for the ingredient to ensure it is safe and will work correctly in your product.

With the Verification Checklist, you substantiate that the ingredient you actually received met the requirements and specifications and is, therefore, safe to use.