Documentation

Record Keeping.

You are most likely looking to a wholesaler (online) and/or a local supplier for your raw materials. When purchasing at lower volumes you wont really receive much technical information outside of what is required about your ingredient.

Usually, you will want to request more information about your ingredient which can come in a varieties of documentation. It is ideal that your vendor can at least provide you with at least a Raw Material Specification.

The listed documents are critical, if applicable, in ensuring you can manufacture a consistent product, that is safe and profitable, throughout the life of your business. These documents can be requested and received by the vendor and manufacturer.

  • The best manufacturing companies make sure they are meeting current client requirements by having the ability to supply their client with a Certificate of Analysis. CoAs are defined as documents that confirms a regulated product meets its product specification. This document usually contains the results obtained from testing performed as a part of a quality control program of an individual batch of a product.

    The CoA generally contains the following information:

    • The name and logo of the company

    • Product being certified

    • Lot number assigned by the manufacturer

    • All the tests performed on the product

    • Properties of the product including but not limited to color, aroma, and components

    • The specification, the criteria of the product to be considered acceptable by the customer

    • All the test results

    • The approval date

      DOWNLOAD - CoA (File)

  • It is important to know the composition, or breakdown, of your chosen ingredient(s). So, let’s identify what an ingredient composition is.

    The percent composition of a compound or an ingredient is a breakdown of the percentages by mass of all the elements in the compound. Another way of looking at it is, a combination of different things, parts, or ingredients composed to form a whole.

    ✎ Example 1

    Lipstick Composition:

    65% Castor Oil

    15% Beeswax

    10% Other Waxes

    5% Lanolin

    5% Dyes, Pigments & Perfume

    ✎ Example 2:

    Whole Egg Composition:

    10% Shell

    30% Yolk

    60% Albumen

    DOCUMENT 1- Composition / Ingredient Statement (File)

    DOCUMENT 2- Composition / Ingredient Statement (File)

  • A product spec sheet is a technical document that outlines the important requirements such as quality, safety, and storage of the ingredient.

    DOCUMENT - Product Specification Sheet (File)

  • Also known as Material Safety Data Sheet (MSDS) includes information for each chemical such as the physical health, and environmental health hazards; protective measures; and safety precautions of handling, storing, and transporting the chemical.

    This document will also provide guidance for each specific chemical such as first aid and spill clean-up procedures. You can always obtain a SDS from the manufacturer.

    DOCUMENT - Safety Data Sheet (File)

  • Understanding what allergens are amongst your raw materials are important. If there is a presence of notifiable allergens and they are above the threshold in the finished product, then they have to be mentioned.

    US:

    Food - CLICK HERE

    Cosmetics - CLICK HERE

    Europe:

    WEBSITE - Allergens - EU guidance

    WEBSITE - Complete List of Allergens

  • A nutritional statement at first may seem to be trivial to spend time on within cosmetics however sometimes we use food items in our formulations. For example, natural preservatives (rosemary extract), fruit powders delivering Vitamin or other nutrients in a body scrub.

    DOCUMENT - Nutritional Statement (File)

  • This document provides guidance for companies that want to make certain label or labeling claims containing detectable genetic material that has been modified through certain lab techniques. It is also to be mentioned that this material cannot be created through conventional breeding or found in nature.

    DOCUMENT 1 - Non-GMO Statement (File)

    DOCUMENT 2 - Non-GMO Statement (File)

  • Kosher Certification is stamp of kosher approval by certification agencies and the Chief Rabbinate of Israel. This process in which a Rabbi certifies that the products referred (usually food products or functional products in the cosmetics and personal care industry) fulfill biblical precepts of the Jewish religion.

    Note that there is a difference between being Kosher Certified and having an issued Kosher Statement. A Kosher statement simply states that the raw material is applicable to receive a certificate if applied due to it having ingredients or an ingredient that meets kosher standards.

    DOCUMENT - Kosher Certificate (File)

    DOCUMENT 2 - Kosher Statement (File)

  • The Flavor Ingredient Data Sheet is a sheet that includes information about certain ingredients used in flavor compounds. This document is used when you are wanting to submit an alcohol beverage formula. If you are using a compounded flavor in your formula that was purchased from a flavor manufacturer you will request this from that manufacturer.

    This document is intended for compounded flavors that includes any flavor, cloudifier, or blender consists of multiple ingredients that are combined to produce a particular flavor profile.

    DOCUMENT - FID (File)

  • Master Formulation Record (MFR) is the most important document in your manufacturing process. This record is essentially equivalent to a recipe that list all the ingredients and steps necessary. Once this record is created it is set in stone and never to be changed to ensure consistency, quality, and safety.

    Each product will have its own Master Production Record that includes the following:

    Bill of Materials (BOM): Each raw material/component needed to manufacture the batch listed with its coordinating weight

    Equipment List: List each piece of equipment that is to be used during any phase of the manufacturing process

    Component List: List each component that is to be used during any phase of the manufacturing process

    Batch Size: You usually want to take your mixing vessels capacity and base your batch size off of that. If your mixing tank has a capacity of 100L you will usually want to go under that capacity to avoid overflowing when mixing and adding various ingredients. You also want to avoid not having enough in your mixing tank. You want to always cover your mixing blade(s)/propeller or the apparatus that is to cause agitation that ensures your product is being mixed.

    FIND YOUR MFR TEMPLATE - HERE

STORAGE

It is recommended that you store all of your required raw material information in one of two ways, or both. Store your documents as paper documents stored in physical folders. Additionally store your documents in a cloud-based system. Not only does this improve edit and version control, it also allows document sharing to be carefully controlled to those that absolutely need the information to perform their role.

q & a

  • Use the USD Food Data Central or the Cosmetics Labeling Regulations website for information for ingredients without specification sheets.

  • These documents help you and your production team ensure quality. When scaling up it is important to check your ingredient upon receiving it’s shipment and it’s document.

    EXAMPLE: An ingredient received at your facility that contains an allergen that was not listen on it’s original specification you required. No one bothered to double check the ingredients document upon receiving. Your product was manufactured with an allergen ingredient that you are unaware of – Result can impact final product and create a recall.