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, but it is now easily accessible to everyone through 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 terms 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.