The 10 commandments

Compliance, nice and easy!

Each month, Aliter Concept offers a reflection on a theme asociated with GMP. Never had to understand, always interesting (well, most of the time!) and opiniated -Hey! Nobody said it is a perfect world! To de-dramatize GMP and to make everybody read about them on a regular basis.

A brief history behind the newsletter

I started writing a compliance newsletter in 1999. Once a month, I would write a few short articles related to GMP for the population of the plant I used to work at. I did this, uninterrupted for almost 7 years.
At first, people did not know what to make of it. Not always serious, sometimes outrageous (e.g. When I suggested to change the date format without consulting the management committee! A no-no let me assure you!), but always easy to understand. I did that first because I felt the need to do it, because I liked writing about it and finally because people appreciated it. It ended up being part of our documented (Yep, in our training SOP and signed by everybody on a quarterly basis!) and ongoing training program.
When I started my own company in 2005, I decided to repeat the experience. I sent my monthly newsletter to the members of the CFP, the Collectif Formation Pharmaceutique, an asociation of pharmatrainers with a mission similar to the GMP TEA. So there you have it!
I will start the English version by loosely translating the first 15 issues of the French ones. Loosely because opinions tend to evolve over time and this newsletter if mostly based on opinions. Firmly grounded in the regulations but …with a personel twist.
Feel free to write your comment, suggestions or just to let me know you are alive and well, at flavallee@aliterconcept.com and let me know if you want those comments published… Blogs are popular these days and so are discussion forums. And watch for the podcast version of this… If the demand is there, I will deliver!
Have you heard about copyright? As long as you ask me permission, I see no problem if you spread the good news, on a limited basis! Ask and you shall receive as the other guy said! However, if you would rather send me names (and emails!) of potential readers, I will add them to the distribution list.
Oh, and by the way, I make no promise to write every month… It might be every two weeks until I keep up with the current French version, that is a back log of 1.5 years. And sometimes, I take vacations… weeks at a time!
Well, as I mentionned above, I do that for the fun of it, if it becomes boring and redundant… PLEASE let me know! In the mean time…
Have fun, learn well and stay compliant!

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!

 

Start with the first commandment!

Par François Lavallée M. Sc.

 

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