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Walthers & Associates
VALIDATION SERVICES

REQUALIFICATION PROGRAM
Walthers & Associates
VALIDATION SERVICES

REQUALIFICATION
• Requalification means confirmation by
examination and provisi...
Walthers & Associates
VALIDATION SERVICES
Requalification Philosophy
• Requalification of equipment is essential in demons...
Walthers & Associates
VALIDATION SERVICES
Requalification Load Cycling
• Load cycling allows all loads which are processed...
Walthers & Associates
VALIDATION SERVICES
Requalification Schedule
• The

following scheduled Requalification studies must...
Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements
• Steam Sterilizers (Autoclaves)
Micro...
Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements (continued)
• Lyophilizers (SIP)
Micro...
Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements (continued)
• Bulk Can S.I.P.
Microbio...
Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements (continued)
• Tunnels
Microbiological ...
Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements (continued)
• Ovens
Microbiological Ch...
Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements (continued)
• Stopper Washers
Microbio...
Walthers & Associates
VALIDATION SERVICES
Requalification Projects and Requirements (continued)

•Bulk Can Pasteurizers
• ...
Walthers & Associates
VALIDATION SERVICES
Requalification Discrepancies and Failures
• All discrepancies from the approved...
Walthers & Associates
VALIDATION SERVICES
Requalifications Not Covered In this Program
Other programs that serve as a form...
Walthers & Associates
VALIDATION SERVICES
In-Process Requalification System Improvements
• Data Trending
• Gives the capab...
Walthers & Associates
VALIDATION SERVICES
Requalification Scheduling

• Production Schedules

• Solutions
• Monthly Schedu...
Walthers & Associates
VALIDATION SERVICES
Future

• APRs
• Work Orders
• Preventative Maintenance
• Change Control Review
...
Walthers & Associates
VALIDATION SERVICES
CONCLUSION

• Questions
• Thank You!
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Revalidation presentation

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This is a revised presentation from a friend back in 1999.

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Revalidation presentation

  1. 1. Walthers & Associates VALIDATION SERVICES REQUALIFICATION PROGRAM
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 16. Walthers & Associates VALIDATION SERVICES Requalification Scheduling • Production Schedules • Solutions • Monthly Schedules • Yearly Calendar
  17. 17. Walthers & Associates VALIDATION SERVICES Future • APRs • Work Orders • Preventative Maintenance • Change Control Review • SOP Revisions • Deviation Review
  18. 18. Walthers & Associates VALIDATION SERVICES CONCLUSION • Questions • Thank You!

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