The tenth commandment : You shall be in compliance
Research ,Discipline, Reviewing because you, dear readers, request it.
The Ninth Commandment : You Shall Control Quality
We do talk a lot about quality when pharmaceuticals are involved. Quality control, quality assurance (oh, by the way the latter does not exist in the Canadian regulation...
The Eighth Commandment : You Shall Be Clean
In our increasingly aseptic world, it is natural to expect a pharmaceutical company to be clean. Extra clean. Totally clean. Our dishwasher soap contains antibacterial agents, our handwhashing soap…
The Seventh Commandment : Competence (Training, Education an Experience) You Shall Have
Nobody will argue that Tiger is a great golfer. And he tees-off perfectly. TEEing-off perfectly is the way to start a great golf game. Receiving the right Training, Education and Experience is,…
The Sixth Commandment : Installations and Equipment You Shall Maintain
The maintenance of our rooms and equipment are the responsabilities of the engineering and maintenance group. Of course. No, bubba! The most important word of the 10 commandment, the word that is…
The Fifth Commandment : Proper Installations and Equipment You Shall Have
What are the conditions or parameters that one should consider to make a room, a building or an equipment proper? Is it possible to transform an old equipment into something new? How can we adapt the…
The Fourth Commandment : Your Work You Shall Validate
How many times should we verify our work? And the work of our colleagues? And why? After all, are we not competent to do things...
The Third Commandment : Your Work You Shall Document
Ever heard of documentation errors? New employees are trained on good documentation practices as soon...
The 10 commandments
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…