Good Manufacturing Practices – Part 2

In this continuation of my series on Good Manufacturing Practices for small cosmetics manufacturers, we’ll look at the recommended practices for handling raw materials, production and laboratory controls.  (See Good Manufacturing Practices – Part 1 for the first of the series.)

4. Raw Materials.

• Raw materials and primary packaging materials are stored and handled in a manner which prevents their mix-up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture.
• Containers of materials are closed, and bagged or boxed materials are stored off the floor.
• Containers of materials are labeled with respect to identity, lot identification and control status.
• Materials are sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microorganisms or other extraneous substances to the extent necessary to prevent adulteration of finished products. Pay particular attention to materials of animal or vegetable origin and those used in the manufacture of cosmetics by cold processing methods with respect to contamination with filth or microorganisms.
• Materials not meeting acceptance specifications are properly identified and controlled to prevent their use in cosmetics.

Discussion:

When you get an ingredient in, correctly label and store all it so it doesn’t become contaminated. The container it came in may be sufficient, but if not, transfer it to an appropriate container that can be properly sealed. For small quantities of dry ingredients or oils, plastic containers with airtight seals work well; 5 gallon buckets are good for larger quantities. Essential and fragrance oils should be held in amber glass or metal bottles (not plastic).

Store all ingredients in the proper environment (temperature, humidity and out of direct sunlight) to ensure the product won’t go bad before you have a chance to use it. That means out of garages and attics that can get very hot or very cold; off patios and decks where they could be in direct sunlight (and get very hot).  I expect that most of you already do this, if for no other reason than to save money!

Keep all containers off the floor.  A low shelf or even boards to keep buckets off the floor will work.

Above all, LABEL EVERYTHING – not just with what it is, but the lot/batch/control number(s) from your supplier.  If you have the lot/batch/control number on the ingredient when it’s stored, you can tell exactly what goes into your product when you make it (important later on in GMP).  Also a good idea is to put the purchase date on the container, so you know exactly when you purchased it and can judge the appropriate shelf life if needed.  Take a small sample of the ingredient when you get it, put it in a container, label it (with all the same information as on the bulk of the ingredient being held) and store the sample safely.  That way you always have a reference sample to come back to  should you need it at any time in the future.

If you have the facility to do so, test ingredients when you get them.  If not, visually inspect the ingredient and make a note of what you see (good or bad).  Also review and check any MSDS and/or technical specification sheets provided by the supplier either with your order on from their website. Keep a copy in your files and connect it to the lot/batch number of your ingredient and also to the sample you kept aside.

If any ingredient arrives that doesn’t pass your inspection, label it as such (and also contact the supplier).  If you go to use an ingredient that has gone bad since you got it, clearly mark on it that it is not to be used in any product so it doesn’t get accidentally used.  If an ingredient does go bad before its time, you have your records and sample to address the matter with your supplier if necessary.

5. Production.

Check whether manufacturing and control have been established and written instructions, i.e., formulations, processing, transfer and filling instructions, in-process control methods etc., are being maintained. Determine whether such procedures require that:

• The equipment for processing, transfer and filling the utensils, and the containers for holding raw and bulk materials are clean, in good repair and in sanitary condition.
• Only approved materials are used.
• Samples are taken, as appropriate, during and/or after processing, transfer or filling for testing for adequacy of mixing or other forms of processing, absence of hazardous microorganisms or chemical contaminants, and compliance with any other acceptance specification.
• Weighing and measuring of raw materials is checked by a second person, and containers holding the materials are properly identified.
• Major equipment, transfer lines, containers and tanks are used for processing, filling or holding cosmetics are identified to indicate contents, batch designation, control status and other pertinent information.
• Labels are examined for identity before labeling operations to avoid mix-up.
  The equipment for processing, holding, transferring and filling of batch is labeled regarding identity, batch identification and control status.
• Packages of finished products bear permanent code marks.
• Returned cosmetics are examined for deterioration or contamination.

Discussion:

The production portion of GMP is primarily addressed to the procedures for large facilities with mechanized production and personnel performing specific tasks, but the fundamentals can, and should, be applied to small, handcrafted cosmetics manufacture.

First of all, make sure you have WRITTEN procedures and controls that cover all aspects of your production (both in general and for each individual product).

At the very least, you should have a written document for each different product you make that clearly states the formulation, the amounts needed for the batch size you are making, the exact procedures for making the product.  Even if only you make product and have done it so many times you could do it with your eyes closed, the documentation should be “stupid-proof” so that anyone which some degree of sense could pick it up, follow the directions and end up with a correctly measured, mixed, filled and labeled.  The directions should include:

• Making sure the equipment to be used is clean and sanitized;
• Checking to make sure the correct ingredients are used (not ones that have been labeled as bad);
• Double checking the weight/measurement of each ingredient (see note below)
• Taking sample(s) as needed;
• If you make several batches at once (i.e. a master batch that is then scented with different scents), the procedures you use to ensure they don’t get mixed up;
• Checking the labels for correctness (including batch numbers) before applying them to the product.

To comply with the “double weighing” requirement, consider weighing out your ingredients in advance (and, of course, correctly labeling each one), and then having another person (friend or family member, maybe) re-weigh them to double-check.  If you make the same product over and over, you could weigh out enough of each ingredient for several batches in advance, or do it when you have a second person available, and hold the containers of double-weighed ingredients until you are ready to use them.

6. Laboratory Controls.

• Raw materials, in-process samples and finished products are tested or examined to verify their identity and determine their compliance with specifications for physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants.
• Reserve samples of approved lots or batches of raw materials and finished products are retained for the specified time period, are stored under conditions that protect them from contamination or deterioration, and are retested for continued compliance with established acceptance specifications.
• The water supply, particularly the water used as a cosmetic ingredient, is tested regularly for conformance with chemical-analytical and microbiological specifications.
• Fresh as well as retained samples of finished products are tested for adequacy of preservation against microbial contamination which may occur user reasonably foreseeable condition of storage and consumer use.

Discussion:

In an ideal world, we would all have the facilities to test water, incoming products, fresh samples and retained product samples, and working toward that idea is the best course of action.

However, in the meantime, you can check incoming raw materials in whatever way you can (visually, odor, etc) and require technical specification sheets from your supplier for the ingredients you purchase.  Keep aside samples of all incoming ingredients, correctly labeled.

Use water that either you test or that has been tested and bottled (i.e. bottled distilled water).  Do NOT use tap water – there may be unknown minerals. chemicals or micoroorganisms in it. Do NOT use spring or well water – it may be perfectly fine to drink, but could (and likely does) contain microorganisms or minterals that could damage your products.

Keep a sample of EVERY batch of product you make.  It doesn’t need to be a full-sized container – a few ounces will do.  But keep a sample of some size, properly label it (with the batch number and date) and set it aside.  If you can’t actually test your samples yet, then visually inspect to make sure they look good, and then check the held samples every so often to make sure they are stable and haven’t deteriorated.

For the rest of the series, see:

• GMP Part 1, which covers Buildings and Facilities, Equipment and Personnel.
• GMP Part 3, which covers Record keeping.