"Risk-based Approach to Revalidation Programs" Webinar, presented by Tara Graf, Transcat's Validation Manager on November 14, 2013 at 2:00pm EST

1. Risk‐based Approach to
Revalidation Programs
By: Tara Graf, Transcat’s Validation Manager
11/14/2013

2. Agenda
• What does the FDA requirement mean for
What does the FDA requirement mean for
revalidation programs?
• Why is the criticality of the equipment an
important factor?
i
f
?
• Why should critical equipment be revalidated
y
yearly?
y

3. FDA Stance / Transcat
FDA Stance / Transcat Stance
• The FDA does not give specifics around
The FDA does not give specifics around
revalidation interval or activities. The FDA
does focus on control over your system.
does focus on control over your system
• A revalidation program requires that all
systems that require validation, as defined by
systems that require validation as defined by
a specific quality system, are evaluated on a
specified interval.
specified interval

4. Critical Equipment
Critical Equipment
• Definition: Instruments used to manufacture a drug,
chemical or product
h i l
d t
• Examples: Fermentors, Bioreactors, HPLC Units,
Dissolution Units, Lyophilizers, Water Systems,
Dissolution Units Lyophilizers Water Systems
Compressed Air Systems, etc.
• Service Actions: Annual Calibration and Validation
• Validation Actions: Test to ensure the equipment
functions the way it was designed to and is still suiting
the need of the process.

5. Secondary Equipment
Secondary Equipment
• Definition: Instruments used to store or test the intermediate
or final products created from a regulated process
f l
d
df
l d
• Examples: Autoclaves, Depy Ovens, Glassware Washers,
Viscometers, Controlled Temperature Units ‐‐for bulk
intermediate or final product store, or sample retain storage‐‐,
i t
di t
fi l
d t t
l
t i t
microplate readers, spectrophotometers, centrifuges, etc.
• Service Action: Annual Calibration, Bi‐annual Revalidation (at
a minimum)
a minim m)
• Validation Action: Prove the equipment is functioning
properly and doing its part in the overall process. Such as, re‐
mapping a chamber, checking the photometric accuracy of a
mapping a chamber checking the photometric accuracy of a
spectrophotometer, testing a loaded centrifuge chamber etc.

6. Tertiary Equipment
Tertiary Equipment
• Definition: Equipment used in a regulated facility that may monitor
a process, used to store media or buffers, used to crudely weigh a
a process sed to store media or b ffers sed to cr del eigh a
buffer solution, etc.
• Examples: Refrigerators, freezers, controlled temperature units,
not holding intermediate or final product, pH meters, conductivity
meters, balances, etc.
• Service Actions: Annual calibration, Revalidation set interval not
,
necessary
• Validation Actions: Continually monitor functionality for negative
trends as a sign of revalidation need or replacement. Such as
trends as a sign of revalidation need or replacement Such as
temperature has started to decline, conductivity readings for known
point of use spots are out of the ordinary, balance is showing drift
and not zeroing out with no weight.
and not zeroing out with no weight

7. Summary
• The interpretation of the regulations is up to
The interpretation of the regulations is up to
the dedicated quality system of each company
but a major element that needs to be present
but a major element that needs to be present
in all revalidation programs is control.
• The criticality of the equipment should and
The criticality of the equipment should and
will impact the amount of revalidation or
calibration performed on it and the frequency
calibration performed on it and the frequency
of the re‐testing.

8. Contacts
• Validation Technical Questions:
Validation Technical Questions:
– Tara Graf: tgraf@transcat.com
• Validation Projects Needs:
– Alisha Powers: apowers@transcat.com