Revalidation presentation

Walthers & Associates

VALIDATION SERVICES

REQUALIFICATION PROGRAM

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.


VALIDATION SERVICES

• Scheduled Requalification

Requalification Philosophy

• Requalification due to Modification

• Support Study (Product Protection)

Three Main Reasons For a Requalification

• 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.


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.


VALIDATION SERVICES

Requalification Schedule

• The following scheduled Requalification studies must be

conducted annually unless a change control warrants

a requalification.

Depyrogenation Tunnels Depyrogenation Ovens

Steam Sterilizers Stopper Washers

SIP Systems: Pasteurizers:

Lyophilizer Bath Type Pasteurizers

Bulk Can Bulk Can Pasteurizer


VALIDATION SERVICES

• 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

Requalification Projects and Requirements


VALIDATION SERVICES

• Lyophilizers (SIP)

Microbiological Challenge:





• D-Value 1.5

• Results

• No Growth

• SAL 10-6

Physical Challenge:

• CFR 600.11

• 22 Fo

• Overkill

Requalification Projects and Requirements (continued)


VALIDATION SERVICES

• Bulk Can S.I.P.






• D-Value 1.5

• Results

• No Growth

• SAL 10-6

Physical Challenge:

• CFR 600.11

• 22 Fo

• Overkill



VALIDATION SERVICES

• Tunnels


Pyrogen Indicators:

• Endotoxin

• E. coli

• 3 Log Reduction

Physical Challenge:

• Differential Pressures

• HEPA Certification

• Belt Speed

• Time at Temperature

• Process Reproducibility



VALIDATION SERVICES

• Ovens


Pyrogen Indicators:

• Endotoxin

• E. coli

• 3 Log Reduction

Physical Challenge:

• Differential Pressures

• HEPA Certification

• FH 30 Equivalent Minutes At 250C



VALIDATION SERVICES

• Stopper Washers


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



VALIDATION SERVICES


•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


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.


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.


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.


VALIDATION SERVICES

• Production Schedules

• Solutions

• Monthly Schedules

• Yearly Calendar

Requalification Scheduling


VALIDATION SERVICES

Future

• APRs

• Work Orders

• Preventative Maintenance

• Change Control Review

• SOP Revisions

• Deviation Review


VALIDATION SERVICES

• Questions

• Thank You!

CONCLUSION


VALIDATION SERVICES

Technology

Revalidation presentation