The first commandment : procedures you shall write
DEATH BY SOP ! Sometimes I think that the FDA, HPFBI, MCA and WHO all have that in mind when they ask to see our procedures !
C.02.006 Interpretation 5 : GMP refresher
How can it be clearer? Human Performance Improvement (HPI... yep, training groups are progressively called HPI teams) personnel are frequently asked what is the target audience for a given course or…
C.02.006 Well-shoed shoe-maker
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…
C.02.006 Interpretation 5.4 :documentation
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…
C.02.006 Qualification
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…
C.02.006 After all it’s all about people!
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.…
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 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…