FDA on Process Validation ((2010):
)
 “The collection and evaluation of data, from
the process design stage throughout
production,
d ti
which
hi h establishes
t bli h scientific
i tifi
evidence that a process is capable of
consistently delivering quality products”
products
Purpose:
Purpose: to demonstrate “SISPQ”
SISPQ
 Strength, Identity, Safety, Purity, Quality
 Includes product attributes & data integrity
2
3
 Installation Qualification (IQ)
 Verifies the aspects of a facility, utility, or equipment
that can affect product quality adhere to approved
specifications (e.g. construction, materials) and are
correctly installed
 Operational Qualification (OQ)
 Challenges the functionality of critical components,
to show they are capable of operating within
required limits and tolerances
 Performance Qualification (PQ)
 Testing the overall capability of the equipment or
system using practical and statistically relevant
samples in a normal operating environment
4
Assume this aseptic
p filling
g line has
already been installed as you see it
here.
A group will be created for each
station to analyze and propose an
IQ/OQ
Q/OQ approach to validate that the
line can package the client’s products
Ti
Time
(approximate):
(
i
)
30 minutes in groups
3-5 minutes to report afterwards
Equipment,
q p
,p
processes,, and p
products
that are in scope
Critical Quality
y Attributes ((CQA))
imparted to the product and/or data at
each station
Critical Process Parameters (CPP)
that allow control of the CQA
Critical In-Process Controls (CIPC)
monitor CQA or CPP at each station
Process – as demoed for the aseptic
p
filling line, with the following stations:
 Vial washing – pre-configured program
 Sterilizing tunnel – fixed speed
 Powder filling – dry antibiotic powder
 Checkweighing – pre-fill and post-fill
 Stoppering – with 20mm full-insertion
stoppers
t
 Crimping – 20mm aluminum seals with a
green top,
top tear-off
Product – client bought line to run:
Molded vial sizes: 10, 15 & 20mL
Fill weight
g range:
g 250mg
g – 2.5g
g of
antibiotic dry powder
Minimum throughput
g p desired:
 120, 100, & 80 vials/min respectively
Sterilization:
Ste
at o sta
standard
da d req’s:
eq s
 (≥5min @ 320°C, laminar flow,
discharge ≤25°C)
 As suggested on the form handouts:
 Materials of Construction, Welds, and Lubricants
(product contact)
 Major hardware components (model #s, serial
#s, design / nameplate ratings, etc.)
 Major software / automation components (what
controls & monitors the equipment?)
 Calibration for “critical” instrumentation
 GMP/Quality System programs (Maintenance,
Calibration, Logbooks, SOPs, Training, etc.)
 Drawing, wiring & code walkthroughs
 Any other important environmental & installation
considerations relevant to product quality
Critical Quality Attributes (CQA)
Critical Process Parameters (CPP)
Critical In-Process Controls (CIPC)
(
)
 Identify
y these as p
part of your
y
report:
p
 Ask: why is this station here?
 Ask: what controls can an operator
manipulate and why might they do so?
 Ask: what do the sensors do and why?
 Ask:
A k what
h is
i at risk
i k if a component fails?
f il ?
Out of scope for the workshop, but
think about:
Normal operating ranges of
equipment + line as a whole
Bracketing “worst case” input
parameters for testing
Number of replicates to demonstrate
process delivers “consistent”
quality for each (or across) products
 Statistical Approaches & Sampling
1) Briefly describe your station and its CQA, CPP,
and CIPC
2) IQ Teams: assume installation is already
completed and the instruments are calibrated.
Wh t needs
What
d IQ for
f your station?
t ti ?
3) OQ Teams: describe what functionality needs OQ
((especially
p
y those relevant to the CPP,, and CIPC))
4) Consider what process and product combinations
will need to be run for your station to demonstrate
its performance in delivering product of
acceptable CQA under normal operating
conditions (PQ)
Note: Mssrs.
Mssrs Stoicovici,
Stoicovici Collins,
Collins and Melamud will
walk around to each station to answer any
questions you may have
Contact Information
Paul A. Melamud
Validation Manager
paul.melamud@qpharmacorp.com
973-656-0248, x2008
Scott Collins
Senior Validation Manager
scott.collins@qpharmacorp.com
973-656-0248, x2110
QPharma Inc.
22 South Street
Morristown, NJ 07960
www.qpharmacorp.com