Page 5 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

QUALITY ATTRIBUTES

Purity means being free of all foreign matter.
Contamination to purity can come from incorrect
machine setups, as shown here, or by using dirty

equipment. An impure product could easily cause
PURITY dangerous patient side effects, so there is strict GMP
for controlling potential product contamination.

Sometimes a contaminant can be present, but
cannot be seen. It is very difficult to test for the
presence of all possible contaminants.

Identity means having the right product in the right

container with the right labels. If a product is
incorrectly identified, a patient may take the wrong
IDENTITY
strength of medication, or even the wrong medication
entirely. These two situations could then easily cause
severe health problems, or in extreme cases, death.

An effective product is one that produces the desired
result without any unwanted side effects. Mis-

EFFECTIVENESS formulating a product or making on error in
manufacture could cause a product to lose its
effectiveness, leading to patient harm.

Safety means being free from danger or risks.
Consumers have the right to be given drugs that are
SAFETY safe and effective. A safe product does not cause
consumers adverse reactions when token at

prescribed doses.

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