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Author Biography:

Marie Gale   is the author of Soap and Cosmetic Labeling; How to Follow the Rules and Regs Explained in Plain English and Good Manufacturing Practices for Soap and Cosmetic HandCrafter’s. She has been actively involved in the handcrafted soap and cosmetic industry for over 10 years and is Past President (2004-2009) of the Handcrafted Soapmakers Guild (www.soapguild.org). Marie can be found by visiting her website at www.mariegale.com

What are “Good Manufacturing Practices”?
By Marie Gale Tuesday, August 13, 2013
The idea behind having, and consistently using, established practices and procedures is that you consistently end up with the same high-quality product every time, every batch, every bar or bottle.

Simply stated, “Good Manufacturing Practices” are the practices and procedures used in manufacturing that ensure a good finished product.

There are industry standards that detail what good manufacturing practices entail. They are called GMP “guidelines.” In the US, there are GMP regulations for drugs, food supplements and food, but not cosmetics. Instead, the FDA has a GMP Inspection Checklist[i] which covers what they expect in order to ensure that a cosmetic product is not adulterated or misbranded. The only official Cosmetic GMP Guidelines are those issued by the International Standards Organization as ISO 22716[ii].

Developed over a long time with lots of experience in what could go wrong, GMP Guidelines go much further than just what you do when you are making your product. They cover everything before, during, after and surrounding the actual making of the product and set some standards on how each potential problem can be avoided. This includes how the space or facility is set up and maintained, organizational structure for overseeing and approving product manufacture, personnel training, safety and hygiene, supplier approval, ingredient specifications and approval, tracking ingredients and materials, documenting production of batches of products, quality control, records management and handling returns or problem products.

When thinking about getting in your own Good Manufacturing Practices, keep in mind that the guidelines are just that – guidelines. While there are some things that are generally the same for everyone, the details and specifics will be unique to you and your situation. You probably won’t have to deal with overhead pipes dripping into your mixing pot, but you still need to make sure your space is free of contamination.

If you make a good product, you already have many good practices in place. You work in a clean space, you measure carefully and correctly, you follow your recipe, you use good ingredients from suppliers you trust. These things that you already do while to make sure your product is at the quality level you want are the core of your good manufacturing practices.

If you want to start establishing your own official Good Manufacturing Practices, these are the four points that most handcrafters should start on first:

1. Good Manufacturing Practices should be written down.

Whatever you already do to ensure your product is high-quality should be in a written procedure. It’s not enough to have it in your head – it needs to be written down in a way that can be clearly understood and could be done by another person who is reasonably familiar with the processes you use.

Having your procedures in written form is not just a drill for complying with the guidelines, it’s a really good idea for several reasons. First, you don’t have to “remember” what to do every time you go to make a product, reducing the chances of errors, especially on products you don’t make often. Second, when you get to the point of having helpers or employees, you have the procedures ready to give them which will reduce training time and ensure your product quality doesn’t drop if someone else makes it for you.

2. Assign and track lot numbers for all ingredients and materials used in the product and packaging.

Whenever you receive an ingredient or packaging material to be used in your product, 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.

3. Keep a written record of each batch you make.

Called a “Batch Record,” this is a written document of exactly what you did when you made the batch. You can start with a copy of your recipe and initial each item as it is measured and added, note temperatures or other key things you check to make sure the batch is right. Note on the Batch Record the lot number of each ingredient or packaging material used in the batch.

4. Assign each batch a unique batch number.

Every batch of product you make should be assigned a unique batch number, so it can be easily identified. Ideally, the batch number should go on the label (per GMP guidelines) – but it is not required according to the cosmetic labeling regulations. Using the date and a letter works well (i.e. 2013-04-01-A, 2013-04-01-B, etc.).

Once you implement just these four steps, you can get your good manufacturing practices bumped up to the next level, moving you much closer to full compliance with GMP guidelines. Not only that, you will have taken some major steps toward making sure your product is of the highest quality – every batch, every bar or bottle, every time.

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