Pharmaceutical GMP Auditiing

[boston night owl]

Been a consultant for three years, unsure if should take a full time job, but job situations are still spotty and have had some down time, between assignments. Was offered full time with pharmaceutical company. Looking to share ideas with everyone. Would be working with GMP auditing and compliance. What do you think? Thanks for the feedback

 

[Al Dyer]

Welcome Owl,

Now to the gist of my comment,

What is GMP and what are you talking about????

Maybe a few details would help us.

Al...

 

[Jimmy Olson]

pancreas said:

What is GMP and what are you talking about????

Maybe a few details would help us.

Al...

Hi Al,

GMP refers to Good Manufacturing Practice and is related to the FDA Quality System Regulation. (that's about as much as I know about it so far)


Night Owl,

Welcome to The Cove

If you look in the 'FDA and Medical Devices' thread you will probably find some information there (although I think most of the discussions revolve around devices and not pharmaceuticals). As to your posting, are you just looking for general ideas to bounce around? If so, you definately came to the right place. I for one will appreciate the discussions as we are looking at possibly going that route.

 

[Al Dyer]

Thank you for the info!!!

 

[Dan Armstrong]

Welcome to the Coves.
I've been working in cGMP comliance auditing for a generics manufacturer of non-sterile solid dosage forms for the past ten years. You won't find a lot of information in the coves specific to the GMP's, but if you set up your quality system in the ways suggested here, you'll be well on your way to passing an FDA inspection. Particularly since the FDA is now moving to systems-based inspections.
I've been a lurker here for a couple of years, picking bits of information here or there, but since we are not ISO certified, nor do we have any plans of becoming so (no bang for the buck for us), I haven't had much to contribute. If I can help you in any way, let me know.

 

[Sarah]

GMP versus GLP (Good Laboratory Practices) Auditing

Is the difference the obvious or is there more to it.

Just a little background... My company is a manufacturer of pharmaceutical equipment for preclinical studies.

 

[Aaron Lupo]

Boston-

It sounds like it may be a great oppurtunity. I know the pharmacetical industry is very strict 21CFR58 for GLP's 21CFRpart 11 for the electronice records compliance. If you do not have a lot of background you may want to look up the site below and do some reading. As Dan stated if you set the system up following ISO you will be in pretty good shape, however, there are a few more requirments that you will need to meet, but ISO is a good jumping off point. Let me know if you would like additional information and good luck!


http://www.fda.gov/cder/gmp/index.htm