Good Manufacturing Practices – Part 1

This is the first of a series of posts on the subject of Good Manufacturing Practices (GMP) for cosmetics, especially as applicable to making handcrafted cosmetics in small batches.

The Regulations

Cosmetics are sort of the bastard-child when it comes to GMP regulations. Both drugs and food have GMP standards set out in the regulations, but cosmetics do not. However, the FDA has published GMP Guidelines/Inspections Checklist for cosmetics. Originally it was an obscure document for inspectors, it is now easily accessible on the FDA website.

The FDA’s authority over cosmetics comes down to making sure that cosmetics for sale through interstate commerce are not adulterated or misbranded.  The FDA defines these as:

A cosmetic may be deemed adulterated for essentially four reasons, namely:

  1. It may be injurious to users under conditions of customary use because it contains, or its container is composed of, a potentially harmful substance.
  2. It contains filth.
  3. It contains a non-permitted, or in some instances non-certified, color additive.
  4. It is manufactured or held under insanitary conditions whereby it may have become injurious to users or contaminated with filth.

A cosmetic may be deemed misbranded for reasons of:

  1. False or misleading labeling.
  2. Failure to state prominently and conspicuously any information required by or under authority of this act.
  3. Misleading container presentation or fill.

The FDA’s GMP Guidelines/Inspection Checklist covers all the points that could (or do) lead to a cosmetic being adulterated or misbranded.  Many are common sense and are easy to comply with for handcrafters making cosmetics in their home or a small shop (but might be of issue for large, commercial, factory-like facilities).

There are 10 areas of inspection.  I’ll cover the first few in this post and the rest in subsequent posts.

1. Building and Facilities.

  • Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance.
  • Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and are kept clean and in good repair.
  • Fixtures, ducts and pipes are installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment, or finished products in bulk.
  • Lighting and ventilation are sufficient for the intended operation and comfort of personnel.
  • Water supply, washing and toilet facilities, floor drainage and sewage system are adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness.

Discussion:

Having appropriate facilities is relatively easy to comply with.  Most handcrafters are unlikely to work in an environment where there are pipes or condensation overhead and dripping into the mixing bowl!

2. Equipment.

  • Equipment and utensils used in processing, holding, transferring and filling are of appropriate design, material and workmanship to prevent corrosion, buildup of material, or adulteration with lubricants, dirt or sanitizing agent.
  • Utensils, transfer piping and cosmetic contact surfaces of equipment are well-maintained and clean and are sanitized at appropriate intervals.
  • Cleaned and sanitized portable equipment and utensils are stored and located, and cosmetic contact surfaces of equipment are covered, in a manner that protects them from splash, dust or other contamination.

Discussion:

Using good and appropriate equipment that is easy to clean and maintain is also pretty common sense. No one making cosmetics in small batches is likely to have equipment that allows for dirt to build up and thus adulterate the cosmetics being made.

Of note, it is important that equipment and utensils be covered after being cleaned and stored, so they won’t become contaminated (dusty, dirty or splashed on, for example) before they are used again.  Surfaces should be kept clean, covered when not in use if possible (although it’s probably acceptable (and advisable) to clean/sanitize surfaces before use if they are not used and cleaned on a regular basis.

3. Personnel.

  • The personnel supervising or performing the manufacture or control of cosmetics has the education, training and/or experience to perform the assigned functions.
  • Persons coming into direct contact with cosmetic materials, finished products in bulk or cosmetic contact surfaces, to the extent necessary to prevent adulteration of cosmetic products, wear appropriate outer garments, gloves, hair restraints etc., and maintain adequate personal cleanliness.
  • Consumption of food or drink, or use of tobacco is restricted to appropriately designated areas.

Discussion:

Well, you don’t want to have unqualified personnel making your product!  So make sure that you know what they are doing, and if you have someone making the product for you, make sure that they know what they are doing. Having documented procedures is helpful in ensuring that the people (including yourself) doing the work know what to do.  Written procedures also serve as a way of proving that the personnel have the training/experience to do the job.  Besides, it’s hard to remember every little procedure, especially if you are making several different types of products.

A lab coat, besides being cool and professional looking, is excellent for protecting against possible contamination (no cat hairs from your shirt falling into the lotion), and gloves and hair restraints are not just a good idea.  Remember also that for soapmaking, protective goggles are a must.

Lastly, have your snacks elsewhere and concentrate on the work at hand when making cosmetics.  Again, no chips or cracker crumbs in the bath bombs!

More to come

In upcoming posts, I’ll cover the next parts of the Good Manufacturing Practices Guidelines and Checklist.

For the rest of the series, see:

  • GMP Part 2, which covers Raw Materials, Production and Laboratory Controls.
  • GMP Part 3, which  covers Record keeping.

Comments

  1. Ms. Gale. I am in the beginning stages of putting my products on the market. I have asked many people that are small businesses like myself and have received many different answers as to what the rules are. Thank you for making it so clear and concise. Christine.

  2. Thanks Marie! I live in the UK and can’t find any information over here that is as clear and informative as the advice you have given here and in the other 2 parts of this discussion. Thank you for sharing your experience and advice – very much appreciated!

  3. This is GREAT! Thank you so much for starting this series as its directly applicable to my small biz and an issue I have been concerned about. I really want to make sure I’m producing my items according to high standards so thank you for these posts. May be good content for another book….I know I’m interested.

  4. Greetings Ms.Gale, I am just starting up on my new venture , thank you for all this very helpful information. Can you please tell me if there is a standard notification that should be placed on every label for every product that has not been formally lab tested? I see most labels displaying a similar sentence or two with respect to “not been tested”. Also, is there only one reccomended organization that offers acceptable bar code or UPC labeling? It seems like there is only one that is reccomended but seems to come with a heft price tag to join and purchase a number of codes. Thank you!

    1. Author

      There are no standard notifications required for cosmetics other than some specific warning labels required on certain products (bubble bath, feminine products, aerosol containers, etc). There is a warning label for a product whose safety has not been determined. It must be placed on the front of the product in large (1/8″) bold letters. I’ve never seen it used on a product for retail sale. It IS your responsibility to ensure that the product is not adulterated or misbranded; testing is not required, however it is a good way to determine the actual status of your product over time.

  5. Maybe I’ve missed the correct article but I’m looking for “Good Manufacturing Practices” for home based business selling cosmetics and lotions etc. We sell on line and I already see we have lots of work to do to change our site but I also want to work on making sure my home is set up correctly (yes I read the article on Brambleberry) and wondered what kinds of advice or articles you could lead me to to help me/us make sure we are being compliant. We are still very very tiny so it’s a good time to make sure we are doing everything correctly. We had a situation where we sort of fell into the business and are now working very hard to follow all the rules, which isn’t easy when you don’t know what all of them are! Thanks so much, this info is great.

    1. Author

      There aren’t any Good Manufacturing Practices specifically for handcrafters or home based businesses. All we have (in the US) are the GMP guidelines from the FDA and the ISO 22716 GMP standards for cosmetic manufacturers. It’s difficult, because they are both intentionally somewhat vague, and the actual application has to be adapted to each individual situation.

      I do plan to post more about GMP for handcrafters, but in the meantime, you should read the articles in my blog under the GMP category, study the new FDA draft guidance (2013) (here), get the ISO 22716 standard (available here for about $125), and, of course, get my GMP book (from Amazon, here).

      The most important aspects of GMP all lead to ensuring that your product is clean, safe, properly labeled and that you have procedures in place to eliminate all the things that could make it otherwise. If you haven’t already, start with figuring out and documenting your EXACT processed for making your products and keeping them clean, then your processes for handling incoming ingredients, and then your procedures for keeping your space clean. Write everything down in a way that anyone could do it if you weren’t there.

      It’s a long process, not something that is finished over night (or maybe even ever!). Just continue to improve the situation as your business grows.

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