The second commandment : procedures you shall respect


Once the procedures are written up, a lot of them end up on a shelf or in a binder in a supervisor’s desk. Under lock and key! TOO FREQUENTLY ! And too frequently, this is observed by…

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 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.…

C2EO for large group?


I'm not sure yet on the use. We run Orientation classes sometimes as small C2EO for large group?as a couple people and as large as 35. Maybe we would use it for annual refresher training. What kind…

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The tenth commandment : You shall be in compliance


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

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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...

commandement

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…

commandement

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,…

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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…

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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…

C2EO for new hires?


Whenever new employees are hired, the training department has a responsibility...

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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...

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The Third Commandment : Your Work You Shall Document


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

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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…