We're going to now cover SOPs as part of
a quality centric process within the pharmaceutical industry.
It's Dr. Laura Brown.
I'm a QA,
and training consultant within the pharmaceutical industry,
and I've had a wealth of experience of both writing SOPs,
reviewing them, and also of course, working to them.
Today, I'm going to be talking to you about
SOPs as part of a quality centric process system.
The key objectives here,
are to enable you to see how important SOPs are as a part of having this quality process,
and this industry is now very focused on quality,
and there are a number of documents around which require
us to document that we've got a quality system.
SOP are one way of achieving that.
Hopefully, what you'll be able to do at the end of this, is see how
important SOPs are as a central part of having a quality system.
As part of having a quality system in place,
it's quite important to be understanding of the definitions in this area.
Two definitions which are used a lot,
are quality assurance and quality control,
and in terms of understanding the difference between these,
quality assurance, is looking at the total aspects within the particular GXP
of how your setup, organised, what quality you have,
and it's ensuring that all of the specific quality steps are in place.
On the other hand, quality control is
a sampling of have you got a good quality assurance process.
For example, if you're doing a manufacturing process,
then you should have checks at specific points
to make sure the sample meets the right specification,
or that everything's been packaged properly,
you're not going to check every single production or product,
you're going to just sample them and that is adequate.
That is the key difference between quality assurance and quality control,
and you have to have these in place for all aspects of in our industry.
Monitoring is a form of quality control.
It's done at specific times,
whereas when you have the auditor coming,
they're also checking that you have got
that process of the quality control working appropriately,
but they've established what that will be for
the total processes within that particular GXP area.