<s>
Process	B-Application
validation	I-Application
is	O
the	O
analysis	O
of	O
data	O
gathered	O
throughout	O
the	O
design	O
and	O
manufacturing	O
of	O
a	O
product	O
in	O
order	O
to	O
confirm	O
that	O
the	O
process	O
can	O
reliably	O
output	O
products	O
of	O
a	O
determined	O
standard	O
.	O
</s>
<s>
Regulatory	O
authorities	O
like	O
EMA	O
and	O
FDA	O
have	O
published	O
guidelines	O
relating	O
to	O
process	B-Application
validation	I-Application
.	O
</s>
<s>
The	O
purpose	O
of	O
process	B-Application
validation	I-Application
is	O
to	O
ensure	O
varied	O
inputs	O
lead	O
to	O
consistent	O
and	O
high	O
quality	O
outputs	O
.	O
</s>
<s>
Process	B-Application
validation	I-Application
is	O
an	O
ongoing	O
process	O
that	O
must	O
be	O
frequently	O
adapted	O
as	O
manufacturing	O
feedback	O
is	O
gathered	O
.	O
</s>
<s>
Process	B-Application
validation	I-Application
can	O
be	O
broken	O
down	O
into	O
3	O
steps	O
:	O
process	O
design	O
,	O
process	O
qualification	O
,	O
and	O
continued	B-Application
process	I-Application
verification	I-Application
.	O
</s>
<s>
Process	O
design	O
is	O
the	O
first	O
of	O
three	O
stages	O
of	O
process	B-Application
validation	I-Application
.	O
</s>
<s>
CQA	O
are	O
an	O
essential	O
aspect	O
of	O
a	O
manufacturing	O
control	O
strategy	O
and	O
should	O
be	O
identified	O
in	O
stage	O
1	O
of	O
process	B-Application
validation	I-Application
:	O
process	O
design	O
.	O
</s>
<s>
Process	O
qualification	O
is	O
the	O
second	O
phase	O
of	O
process	B-Application
validation	I-Application
....	O
</s>
<s>
Continued	B-Application
process	I-Application
verification	I-Application
is	O
the	O
ongoing	O
monitoring	O
of	O
all	O
aspects	O
of	O
the	O
production	O
cycle	O
.	O
</s>
<s>
Continued	B-Application
process	I-Application
verification	I-Application
is	O
stage	O
3	O
of	O
process	B-Application
validation	I-Application
.	O
</s>
<s>
This	O
alternative	O
method	O
of	O
process	B-Application
validation	I-Application
is	O
recommended	O
by	O
the	O
EMA	O
for	O
validating	O
processes	O
on	O
a	O
continuous	O
basis	O
.	O
</s>
