The 10 commandments
Compliance, nice and easy!
A brief history behind the newsletter
The 10 commandments of GMP
Why the 10 commandments of GMP? And why not! The 10 commandments of GMP, although apprarently religious in nature, are an easy way to remember and apply the basic principles behind GMP. Because we are really talking about basic principles. As the saying goes : « Give people a set of complex rules and you will get repetitive and stupid behaviours; give them a set of clear and simple principles and you will get intelligent and creative behaviours. » (Sorry about this, but I cannot recall the exact words of the quote…)
Therefore the 10 commandments.
At the very foundation of this, sometimes dry and rather serious regulation are a set of requirements that are the direct results of decades of investigation to protect the public. This public so frequently neglected in the past 150 years, often taken hostage of big corporations, pharma or others and victim of disinformation campaigns. 10 commandments that are a simple answer to several misunderstood regulation articles. Hey, I would love to be able to say that I invented those commandments, but no, they go back to the ten principles of GMP from the GMP institute, several years ago. Loosely adapted from the following list, the ten commandments are a fun and interesting way to cover the regulations.
Original list, slightly modified by JWM and Associates.
1- Procedures must be written
2- Written procedures must be followed
3- Work must be recorded or documented
4- All work must be validated
5- Proper facilities and equipment must be designed and/or available
6- Facilities and equipment must be maintained
7- Competence must be maintained as a result of education, training and experience
8- Cleanliness levels must be defined and observed
9- Quality must be controlled throughout all processes
10- Audits must be performed to assess compliance.
A great idea! The list I use was found on an old poster that was lying, forgotten, in my first office a few years ago when I started a new job at… Well you know.
So there you have it, the topics for the next 10 issues : The ten commandments, reviewed by yours truly!
Keep on having fun educating your colleagues!
P.S. Interested in submitting an article? Don’t be shy! Write to me!
Par François Lavallée M. Sc.
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