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…