Do you know the internet? Not the one we use for online shopping but the one that is full of information about compliance. I was looking through the Health Canada web site recently, looking for some…

I once participated in a discussion on LMS. Learning Management System. Another one of those systems that our IS department just loves to install... and validate! Another one of those systems…

I like puzzles. Like this one : Why should a supervisor need to be a university graduate to supervise in the manufacturing area but NOT in the packaging area? The Canadian regs are pretty explicit…

I am always flabbergasted to see the mess whenever the fundamentals are neglected. When we forget to look for the root cause of any problem, we keep having the problem or worse, it gets amplified.…

Research ,Discipline, Reviewing because you, dear readers, request it.

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...

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…

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 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…

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…

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...

Ever heard of documentation errors? New employees are trained on good documentation practices as soon...

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…