Good Manufacturing Practices (Paperback)
by Marie Gale
Most people who make handcrafted soaps and cosmetics do so because they want better, safer or more natural products and have a personal passion for what they are doing. They are conscientious in their selection of suppliers and raw materials, creative in their formulations, careful in their production and, in the end, proud of the finished products. They have control over every phase and aspect of the production cycle, from beginning to end, and are frequently hands-on during the entire process.
Large companies, with many employees involved in manufacturing tens or hundreds of thousands of product units at a time, don’t have that same level of “hands-on” or personal passion. With increased levels of automation and numerous people in the process comes increased possibility for mix-ups or contamination of products—hence the need for detailed and exact procedures that can be double-checked and documented throughout the manufacturing cycle. Out of that need comes the concept of “good manufacturing practices”.
Establishing and then following good manufacturing practices in your business is like having and using a GPS navigator to get around town. No matter how familiar you are with the streets, it takes a lot less effort to just follow the directions. The trick, of course, is having all the necessary information in the navigator to start with. That’s what GMP is all about—setting up the navigation system for your production and manufacturing, so you can avoid the potholes and steer clear of the factors that could potentially wreck your product.
The basics of good manufacturing practices aren't too hard to grasp. Think of your GMP as the roadmap of all the steps necessary to get your high quality product produced every time. If you're making good products now, then you must already be following the guidelines to some degree.The question is, do you have it documented so you know the same steps are being followed every time?
There are 8 main parts to GMP:
First and foremost, all of the practices you follow when making your products need to be documented.
Standard Operating Procedures
Standard operating procedures (SOPs) are written documents that cover non-product-specific things that have the potential of indirectly affecting your product quality. Basically, they list the why, what, when, where, who and how of every procedure you do.
Specification sheets detail the specifications that must be met for any ingredient or packaging material used in your products or in your manufacturing of them.
Ingredient & Material Lot Numbers
All ingredients and materials used in your products should be assigned lot numbers when they are received. The lot numbers must be traced through the manufacturing process and tied to each batch in which the lot is used.
You probably already have a master formula for each of your products. The master formula should include not only the ingredients and materials used in the product, but also step-by-step directions on how to make the product. It is what is supposed to be done.
Batch records are a written record of what what actually done when a batch was made.
As part of GMP, a unique identifying number should be assigned to each batch, and the number placed on the package label for every product from that batch.
Quality control covers change control (determining when processes or procedures should be changed) and reviewing and handling any returns, complaints or recalls of products.
This book sets out to dispel some of the fear and anxiety about good manufacturing practices and provides you with practical advice about establishing good manufacturing practices that work for you, in your individual situation. As each piece of your GMP is put in place, you’ll find it becomes increasingly easy to consistently produce the unique, high-quality handcrafted soap and cosmetics that you and your customers expect—every product, every batch, every time.