Page 37 - Quality control of pharmaceuticals (07-PA 704)
P. 37
Common sense must prevail. If you know that a result is low because you
spilled part of a solution, then the probability that the result is wrong
is 100% and the datum should be discarded.
Any datum based on a faulty procedure should be discarded, no matter
how well it fits the rest of the data.
General Requirements for Quality Control
There are TWO main items used in any quality – control process.
The first of these is a control material (or “control”). This is a substance
you will analyze periodically by an analytical method to determine
whether the procedure is working in a consistent manner.