This is probably not the most attractive subject to start 2015 with, however since I'm busy at the moment with GMP documentations, I decided to dedicate the first post of this year to cosmetic GMP.
GMP is something that even caused headache to me. There it is, sitting like a huge monster and one tries only to neglect it. Well, it's not always possible.
GMP comes originally from the pharmaceutical industry and is being accepted/revised by the cosmetic industry. In the EC it's mandatory since July 2013. It means, even if you're a soap crafter or lotion crafter, producing only in small scales in your kitchen lab, you've stilly to comply to GMP? And if you're not located in the EC but want to sell in Europe, you should comply?
GMP: Good Manufacturing Practice goes far beyond your recipe and your production process, it covers everything and anything that could affect the quality of your product from hygienic system to shipment of finished products. A major part of GMP is not just DOING what you've to do (cleansing, disinfecting, calibrating your scale and so on) but to write down and document everything you've to do and you should do AND following the documentation.
In simple words GMP is part of a management system and is an operation method/policy to assure that the products meet the following minimum criteria:
1- Consistently manufactured (equal quality from batch to batch)
2- The quality is appropriate for the intended application
3- The product quality satisfies manufacturers predefinition and purposes
4- Nothing is gone wrong/ no mistake has happened during any of the production/storage/control/shipment steps
GMP in the new EU regulation:
1. The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 1.
All cosmetics products sold into the European Market will have to be produced according to the ISO 22716 standard.
Well, if you're already producing and selling in the EC then you're probably familiar with GMP and already comply but if you're on start-up or plan to enter the European market the sooner you start thinking about GMP and planning your business in accordance with GMP guidelines the better. Well started is half done.
Good news for small business:
Although in the EC you should comply with the cosmetic GMP, It doesn’t mean that you need to get approval from an external body to say you comply with this standard. It is assumed that you are, and you are in violating the regulations if you aren’t.
ISO 22716:2007 basically covers:
Personnel (even if you're running a one man show and personnel only consists of yourself)
Facility and equipment
Raw material
Packaging
Production procedure
Finished Product
Quality control
Quality system (Documentation and records)
Waste
Rejected (out of specification ) products
Complaints
Outsources operations
Well, start thinking about GMP as an assistance in your system and not as an additional load and burden forced by the Bruxelles guys.
We'll continue this discussion later.
Be happy and have fun