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GMP and Ingredients
Author: Marie Gale
Tuesday, August 13, 2013

Good Manufacturing Practices ensure good finished products. The ingredients you select and use are obviously key to a high-quality finished product; therefore how you specify, purchase, approve, handle, store, track and use your ingredients is an integral part of Good Manufacturing Practices.

“Good Manufacturing Practices” (GMP) are the practices and procedures used in manufacturing that ensure a good finished product. The ingredients you select and use are obviously key to a high-quality finished product; therefore how you specify, purchase, approve, handle, store, track and use your ingredients is an integral part of Good Manufacturing Practices.

The following guidelines outline best practices for your ingredients. Whether you work out of your kitchen and store your ingredients in a designated shelf or cupboard, or have a dedicated shop, with a little thought and planning these guidelines can easily be adapted for any situation.

1. Specify the ingredient criteria fully.

Often the ingredients listed in a recipe are somewhat generalized and when it comes to actually purchasing the item, you are faced with options. For example, your recipe calls for “Lavender Fragrance”. Is that Lavender 40/42 essential oil? Bulgarian Lavender essential oil? Lavender fragrance oil? A combination? Obviously the end product changes based on which “lavender” you choose.

Having exactly specified criteria is especially important when an ingredient can come in several different forms under the same name. Cornstarch, for example, comes in various grades, particle sizes and treatments (all of which are called “cornstarch”). Which one you use can drastically change your product. You wouldn’t want a coarse or rough particle size for face or body powders, but it might be okay for bath products or as a thickening agent.

GMP Guidelines call for defining the following for every ingredient (or packaging material) you use:
  • Description. What does the ingredient/material look like? Feel like? Smell like? What color should it be? How big or small are the particles? A detailed description is especially essential when dealing with botanicals.
  • Critical Criteria. What criteria MUST be met in order to use the item at all? This is generally criteria that if not met would make the product unsafe or unusable, or which are legally required. Example: negative for eColi and Salmonella.
  • Major Criteria. What is EXTREMELY IMPORTANT criteria? This would be criteria that if not met could affect product quality or result in a lower quality product. Examples: Cornstarch particle size, purity of lye for soap, or whether a botanical is fresh or dried.
  • Minor Criteria. What criteria SHOULD be met? These are things that should be met, but won’t adversely affect product quality. Example: Whiteness level of cornstarch.

2. Select a qualified supplier.

Select and approve suppliers for that ingredient in advance, and only purchase that ingredient from suppliers who have been approved for that particular ingredient.

While price is an important factor, also consider customer service, return policy, shipping policy, and the information provided by the supplier (including technical specifications, quality assurance, usage information and MSDS sheets) when approving a supplier for an ingredient.

3. Assign a lot number to every ingredient/material received.

When you receive an ingredient or packaging material, assign it a lot number. It can be anything that will uniquely identify the EXACT order you received. Keep in mind that if you receive 4 oz. of Lavender essential oil on Monday and another 4 oz of Lavender essential oil on Friday, they are two different lots and should have different lot numbers assigned to them.

Be sure to record the supplier invoice number and date as well as the supplier lot number (if any) so you can trace your lot number back to the exact order from the supplier.

4. Check and approve each incoming lot before using.

Every time an order is received, check the ingredient/material carefully to ensure it meets your specifications. Look at the shipping box – is it damaged at all? Did you receive what you ordered? Does the ingredient meet your critical, major and minor criteria? Keep a written record of what you find.

If the ingredient is acceptable, approve it for use. If not, set it aside – away from approved ingredients – and appropriately handle.

5. Organize Stored Ingredients.

Keep all your approved ingredients stored in such a way that you can easily identify what they are, the lot number and the expiration date (if any). If the ingredient is repackaged into a different container, label it clearly. Don’t combine different lots of the same ingredient!

6. Record the ingredient Lot Number when used in a product batch.

When you make a batch of product, make sure to record the Lot Number of every ingredient used in the batch.

Summary

By implementing these steps, you will have certainty that every ingredient you use in your products has met your quality standards and you will have taken a significant step toward making sure your end products are of the highest quality – every batch, every bar or bottle, every time.





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