Walthers & Associates provides requalification services to confirm equipment is still validated and performing as intended. Requalification includes repeating validation tests or assessments and is required annually, when equipment is modified, or for product protection. Tests evaluate microbial reduction through biological indicators, achievement of required temperatures and pressures, and confirmation of cleanliness. Any failures require corrective actions, further "as found" data collection, and may necessitate change control processes. Requalification aims to demonstrate through objective evidence that equipment continuously meets validation requirements.

1. Walthers & Associates
VALIDATION SERVICES
REQUALIFICATION PROGRAM

2. Walthers & Associates
VALIDATION SERVICES
REQUALIFICATION
• Requalification means confirmation by
examination and provision of objective
evidence that the particular requirements
for a specific systems intended use can be
consistently fulfilled as originally validated.

3. Walthers & Associates
VALIDATION SERVICES
Requalification Philosophy
• Requalification of equipment is essential in demonstrating
that the equipment is still in a state of control and that
intentional changes, such as a change control, have resulted
in delivering the desired effects. A requalification study
may be a full re-execution of the original validation study
or it may include only a portion of the original validation
assessments. In either case, multiple runs conducted for
a specific type of assessment must be independent and consecutive.
Three Main Reasons For a Requalification
• Scheduled Requalification
• Requalification due to Modification
• Support Study (Product Protection)

4. Walthers & Associates
VALIDATION SERVICES
Requalification Load Cycling
• Load cycling allows all loads which are processed through a piece of
manufacturing equipment to be requalified.
This practice keeps a current requalification study on all loads currently
processed through the manufacturing equipment.
• All current loads are cycled until all the loads are re-assessed. Once
all the loads are re-assessed the load cycling starts over from the first
load.

5. Walthers & Associates
VALIDATION SERVICES
Requalification Schedule
• The
following scheduled Requalification studies must be
conducted annually unless a change control warrants
a requalification.
Depyrogenation Tunnels
Steam Sterilizers
SIP Systems:
Lyophilizer
Bulk Can
Depyrogenation Ovens
Stopper Washers
Pasteurizers:
Bath Type Pasteurizers
Bulk Can Pasteurizer

6. Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements
• Steam Sterilizers (Autoclaves)
Microbiological Challenge:
Biological Indicators:
• Vendor Certificate
• Bacillus sterothermophilus
• Population  1 x 106
• D-Value  1.5
• Results
• No Growth
• SAL  10-6
Physical Challenge:
• CFR 600.11
•  22 Fo
• Overkill

7. Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements (continued)
• Lyophilizers (SIP)
Microbiological Challenge:
Biological Indicators:
• Vendor Certificate
• Bacillus sterothermophilus
• Population  1 x 106
• D-Value  1.5
• Results
• No Growth
• SAL  10-6
Physical Challenge:
• CFR 600.11
•  22 Fo
• Overkill

8. Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements (continued)
• Bulk Can S.I.P.
Microbiological Challenge:
Biological Indicators:
• Vendor Certificate
• Bacillus sterothermophilus
• Population  1 x 106
• D-Value  1.5
• Results
• No Growth
• SAL  10-6
Physical Challenge:
• CFR 600.11
•  22 Fo
• Overkill

9. Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements (continued)
• Tunnels
Microbiological Challenge:
Pyrogen Indicators:
• Endotoxin
• E. coli
• 3 Log Reduction
Physical Challenge:
• Differential Pressures
• HEPA Certification
• Belt Speed
• Time at Temperature
• Process Reproducibility

10. Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements (continued)
• Ovens
Microbiological Challenge:
Pyrogen Indicators:
• Endotoxin
• E. coli
• 3 Log Reduction
Physical Challenge:
• Differential Pressures
• HEPA Certification
• FH  30 Equivalent Minutes At 250C

11. Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements (continued)
• Stopper Washers
Microbiological Challenge:
Pyrogen Indicators:
• Endotoxin
• E. coli
• 3 Log Reduction
Chemical Challenge:
Residual Cleaning Agent
•  10 parts per million carryover into the next smallest possible batch.
Particle Challenge:
Liquid Particulates:
•  6,000 particles  10 microns and  600 particles  25 microns

12. Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements (continued)
•Bulk Can Pasteurizers
• CFR 640.91
• 10 - 11 hours at 60°  0.5°C
•Bath Type Pasteurizers
• CFR 640.81
• 10 - 11 hours at 60°  0.5°C

13. Walthers & Associates
VALIDATION SERVICES
Requalification Discrepancies and Failures
• All discrepancies from the approved verification/test procedure
and/or from the approved verification/test acceptance criteria
must be documented on an individual discrepancy report.
• When a failure to meet defined acceptance criteria within a requalification
study occurs, for reasons other than a test equipment failure or a data
collection error, the following must occur:
1. Notification must be given to the area supervisor and Quality Assurance.
2. Potential product/process impact must be assessed.
3. If there is a potential for product impact, “as found” data must be accumulated on the
process prior to making any changes to the process.
4. All associated work to correct the discrepancy must be documented within a
maintenance/calibration work order.
5. Any critical changes to the process must be handled under the change control system .
6. The protocol execution may continue once a corrective action has been implemented.

14. Walthers & Associates
VALIDATION SERVICES
Requalifications Not Covered In this Program
Other programs that serve as a form of requalification:
• Program for water and pure steam
• Program for process simulation testing
• Program for environmental control
• Program for HEPA filters
• Program for equipment calibration
In the event a process requires modification to the design, a change control will be generated
and the qualification status will be evaluated to determine requalification needs.

15. Walthers & Associates
VALIDATION SERVICES
In-Process Requalification System Improvements
• Data Trending
• Gives the capability to view graphical data from
each process from year to year.
•Summary Log
• Gives a quick reference of the summary reports
which appear in the Requalification VFR's.
•Digital Picture Library
• Digital pictures for each process and process
load.
•Process Equipment Reference Guides
• Equipment reference guides will be produced
for each piece of requalified equipment. They
will contain: equipment description,
pictures, memos, trouble shooting guides, etc.

16. Walthers & Associates
VALIDATION SERVICES
Requalification Scheduling
• Production Schedules
• Solutions
• Monthly Schedules
• Yearly Calendar

17. Walthers & Associates
VALIDATION SERVICES
Future
• APRs
• Work Orders
• Preventative Maintenance
• Change Control Review
• SOP Revisions
• Deviation Review

18. Walthers & Associates
VALIDATION SERVICES
CONCLUSION
• Questions
• Thank You!