02a -The Quality Unit & Organization and Personnel B .ppt – cGMP’s B. Organization and Personnel Quality Control Unit = QA & QC QA GMP QC 211.22 a | Course Hero

211.22 (c) Quality Control Unit

Has the responsibility for approving or rejecting all procedures or specifications

impacting:

1.Identity

2.Strength

3.Quality

4.Purity

…of the drug product.

Identity

– biochemical “fingerprint”

Potency

– Strength of dose

Purity

– % of product that is free from impurities.

Stability

– Identity, strength, purity is same at T

0

as

T

exp.

Consistency

– Quality attributes are consistent from

batch to batch

.

Efficacy

(Effectiveness) – The drug should do what it

is supposed to do.

Safety

– The product does not cause undue harm

unless otherwise noted,

i.e.

side effects.

What they are

really

referring to is…