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Validation Form

Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 1 of 17

1.0 OBJECTIVE
Revalidation assessment provides for the evaluation of validation change control, maintenance and
calibration records, operating and maintenance procedures, equipment logbooks, and other evidence
as necessary to assess the validated state of equipment, systems, or processes, and the necessity for
subsequent revalidation in whole or in part, revisions to documents, additional training, etc.

2.0 SCOPE
2.1 Applicability
Process Equipment

2.2 Process Type


Fermentation Blending / Mixing Chromatography Pasturization
Filling Lyophilization Packaging Shipping
Cleaning, Automatic Cleaning, Manual Sterilization Other

2.3 Product(s)
X001 X002 X003 X004
Intermediate Bulk API Finished Dose Buffer

2.4 Production Area


Fermentation Purification Filling / Freeze Pkg / Shipping
Other Other Room No. Building No.

2.5 Equipment / Major Components


ID / Asset No. Type / Description ID / Asset No. Type / Description

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 2 of 17

3.0 REVALIDATION ASSESSM ENT


3.1 Qualification and Validation Document Verification
3.1.1 Check validation documents included in this review. Where the last validation
activity was a Revalidation Assessment that documented original IQ, OQ, etc.,
record only the assessment and any subsequent revalidation.
3.1.2 Record title, number, and QA approval date of final report / validation packages.

IQ OQ PQ PV CV RA RQ / RV Other

Document Title Document No. Approval Date

Date of last validation activity

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 3 of 17

3.2 Change Control History Verification and Review


3.2.1 Record number, description, and opened / closed dates for all Change Control
Requests (CCR) occurring since the last validation activity (3.1). Revalidation
assessment must be paused until closure of open or pending CCRs.
3.2.2 Review CCR documentation and summarize in the Comments box any changes to
system installation, operation, or performance having an impact on the validated
state that were not adequately tested. Record applicable CCR numbers.
3.2.3 Evaluate the cumulative effect of multiple changes if applicable and summarize in
the Comments box potential or evident impact on the validated state.
3.2.4 Summarize recommended corrective actions resulting from change history review.
CCR No. Description Date Opened Date Closed

CCR No. COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 4 of 17

3.3 Equipment Logbook Verification and Review


3.3.1 Record logbook number and dates covered for all logbooks or logbook entries
occurring since the last validation activity (3.1). Record page number of most
recent entry for open logbooks. Check applicability to equipment Operation,
CLeaning, Maintenance, and Calibration.
3.3.2 Review logbook for accuracy and completeness of entries. Assess that operation,
cleaning, maintenance, and calibration activities as applicable were properly
documented.
3.3.3 Note any discrepancies in the Comments box. Record applicable logbook numbers.
3.3.4 Summarize recommended corrective actions resulting from change history review.
Applicability Last Page
Logbook No. Date Opened Date Closed
O CL M C Open Logbook

Logbook No. COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 5 of 17

3.4 Operation, Cleaning, Maintenance, and Calibration Procedure Verification


Record title, number, effective date and revision number of the procedure (include batch
production records (BPR) if applicable to equipment operation and cleaning).
Document Title Document No. Effective Date

Rev:

Rev:

Rev:

Rev:

Rev:

Rev:

3.5 Operation and Cleaning Procedures Review


3.5.1 Review procedural instructions (including BPRs, if applicable) for consistency
with those established in validation documents.
3.5.2 Summarize in the Comments box any discrepancies between validated and
procedural instructions. Record document numbers of applicable procedures.
3.5.3 Summarize recommended corrective actions resulting from procedures review.
Document No. COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 6 of 17

3.6 Validated Parameters Review, Operating Procedures


3.6.1 Record applicable validation and procedural document numbers. Transcribe
validated operational and/or performance parameters from validation
documentation, applicable to equipment operation and cleaning.
3.6.2 Check YES or NO, verifying that parameters specified in procedures and batch
records are consistent with validated parameters.
3.6.3 Review CCRs and revalidation documents to determine whether any noted
discrepancies were previously addressed and resolved. Record document number
and resolved discrepancy.
3.6.4 Summarize in the Comments box discrepancies between validated and procedural
parameters that were not addressed through change control.
3.6.5 Summarize recommended corrective actions resulting from parameters review.

SOP / BPR No. Validation Doc. No.

Consistent w/ Consistent w/
Validated Parameter Value / Procedure? Validated Parameter Value / Procedure?
Description Unit Description Unit
Yes No Yes No

Parameter Discrepancy Resolved Per Document Parameter Discrepancy Resolved Per Document

Logbook No. COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 7 of 17

3.7 Validated Parameters Review, Cleaning Procedures


3.7.1 Record applicable validation and procedural document numbers. Transcribe
validated operational and/or performance parameters from validation
documentation, applicable to equipment operation and cleaning.
3.7.2 Check YES or NO, verifying that parameters specified in procedures and batch
records are consistent with validated parameters.
3.7.3 Review CCRs and revalidation documents to determine whether any noted
discrepancies were previously addressed and resolved. Record document number
and resolved discrepancy.
3.7.4 Summarize in the Comments box discrepancies between validated and procedural
parameters that were not addressed through change control.
3.7.5 Summarize recommended corrective actions resulting from parameters review.

SOP / BPR No. Validation Doc. No.

Consistent w/ Consistent w/
Validated Parameter Value / Procedure? Validated Parameter Value / Procedure?
Description Unit Description Unit
Yes No Yes No

Parameter Discrepancy Resolved Per Document Parameter Discrepancy Resolved Per Document

Logbook No. COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 8 of 17

3.8 Operator Training Verification and Review


3.8.1 Record information applicable to operation and cleaning procedures or batch
production records. Area Trainer initial and date to confirm documented training
for personnel. Assess that operators identified in logbooks and cleaning records are
trained.
3.8.2 Record discrepancies in Comments box and summarize recommended corrective
actions (retraining) resulting from operator training review.
Document Title Document No. Effective Date

Rev:

Rev:

Rev:

Rev:

Document No. COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 9 of 17

3.9 Incident Report (IR) / Corrective and Preventative Action (CAPA) Verification and Review
3.9.1 Indicate type, IR or CAPA. Record number, description, and opened / closed dates
for all IRs and CAPAs occurring since the last validation activity (3.1).
Revalidation assessment must be paused until closure of open or pending IRs or
CAPAs.
3.9.2 Review IR and CAPA documentation and summarize in the Comments box any
related changes to system installation, operation, or performance having an impact
on the validated state that were not adequately tested. Record applicable IR and
CAPA numbers.
3.9.3 Evaluate the cumulative effect of multiple changes if applicable and summarize in
the Comments box potential or evident impact on the validated state.
3.9.4 Summarize recommended corrective actions resulting from IR / CAPA review.
Type Document No. Description Date Opened Date Closed

Document No. COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 10 of 17

3.10 Environmental Monitoring Excursion Report (EMER) Verification and Review


3.10.1 Record number, description, and opened / closed dates for all EMERs occurring
since the last validation activity (3.1). Revalidation assessment must be paused
until closure of open or pending EMERs.
3.10.2 Review EMER documentation and summarize in the Comments box any apparent
trends indicating potential or evident change to system performance having an
impact on the validated state. Record applicable EMER numbers.
3.10.3 Summarize recommended corrective actions resulting from EMER review.
EMER No. Description Date Opened Date Closed

EMER No. COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 11 of 17

3.11 Maintenance History Review


3.11.1 Review maintenance logbooks, forms, or records covering scheduled preventative
maintenance (weekly, monthly, quarterly, annually) and unscheduled maintenance
occurring since the last validation activity (3.1). Record in the Comments box the
number and date of documents recording any incidences where,

• Maintenance activities were not conducted as scheduled


• Equipment or component replacements were not “like-for-like” changes and
not completed through change control
• Recurring maintenance indicating adverse trends having potential or evident
impact on system operation or performance
3.11.2 Summarize recommended corrective actions resulting from maintenance review.
Document No. Date COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 12 of 17

3.12 Calibration History Review


3.12.1 Review calibration requirements for process control instruments, and records
covering scheduled calibration occurring since the last validation activity (3.1).
Record in the Comments box the number and date of documents recording any
incidences where,

• Calibration activities were not conducted as scheduled


• Instrument replacements were not “like-for-like” changes and not completed
through change control
• Instrument sensitivity, resolution, or rated tolerances are inconsistent with
requirements for system performance
• · Variability of instrument performance indicates an inadequate calibration
interval having potential or evident impact on system operation and
performance
3.12.2 Summarize recommended corrective actions resulting from calibration review.
Document No. Date COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 13 of 17

3.13 Validation Requirements Verification and Review


3.13.1 Record title, number, revision number, and effective date of validation policies,
programs, and procedures having requirements applicable to the equipment or
system.
3.13.2 Review qualification and validation final reports to assess consistency with current
validation requirements. Record in the Comments box requirements and associated
documents with which equipment or system qualification or validation is
inconsistent.
3.13.3 Summarize recommended corrective actions resulting from validation review.
Document No. Rev. Document Title Effective Date

Document No. COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 14 of 17

3.14 Drawings Verification and Review


3.14.1 Record title, number, revision number, and approval date of as-built drawings and
diagrams pertaining to the qualified construction, installation, and operation of the
equipment or system, generated or revised since the last validation activity (3.1).
3.14.2 Verify that modifications indicated in revised drawings were completed through
change control. Record CCR number associated with document revision.
3.14.3 Verify that modifications indicated in revised drawings reflect the actual state of
the equipment or system.
3.14.4 Record in the Comments box modifications indicated in revised drawings that were
not completed through change control or are inconsistent with the actual
requirements and associated documents with the actual state of the equipment or
system.
3.14.5 Summarize recommended corrective actions resulting from drawings review.
Drawing and Rev. Nos. Drawing Title Date Approved CCR No.

Drawing and Rev. Nos. COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 15 of 17

3.15 Physical Inspection


3.15.1 Physically inspect the equipment or system and note in the Comments box any of
the following,

• Apparent disrepair or damage potentially impairing operability or functionality


• Rouging, rust, staining, or other corrosion on product contacting surfaces
• Scratches, pitting, gouges, other superficial defects on product contacting
surfaces
• Leaking fluids on or about the equipment
• Aqueous pooling on or within internal surfaces and cavities
• Frayed, pinched or damaged electrical or control wiring
• Other visible defects or irregularities having the potential to adversely impact
the validated state
3.15.2 Summarize recommended corrective actions resulting from the physical inspection.
COMMENTS N/A

RECOMMENDED CORRECTIVE ACTIONS N/A

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 16 of 17

4.0 CONCLUSION
4.1 General Comments
Briefly summarize comments made in the previous sections, noting, collectively, trends
indicating potential or evident adverse impact on control of the validated state.
GENERAL COMMENTS N/A

4.2 Recommended Corrective Actions Summary


Itemize in brief recommended corrective actions identified in the previous sections.
RECOMMENDED CORRECTIVE ACTIONS N/A
1

2
3

4
5

7
8
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10
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12
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15
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18
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20

Completed By Date Reviewed By Date

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Validation Form
Biopharmaceutical 100-01.00
Company Revalidation Assessment
Page 17 of 17

4.3 Required Revalidation and Corrective Actions


Revalidation testing or other corrective action is not required.
The system is operating in a validated state of control.
Yes ¨ No ¨
Revalidation testing or other corrective actions are required to
maintain the validated state of the system (4.2).
Yes ¨ No ¨
Out-of-Service Notification (OSN) is required due to the number
or severity of items requiring corrective action. Yes ¨ No ¨

4.4 Revalidation Assessment Interval


Based on the preceding assessment, revalidation interval is adjusted as follows:

Current Interval Adjusted Interval


Years Months Years Months N/A

4.5 Approvals

Prepared By Department Signature Date

Approved By Department Signature Date

5.0 REVALIDATION COM PLETION

Document QA Approval Verified By


Title No. Date Initial Date

All required actions (4.2) completed and approved? Yes ¨ No ¨


Next Revalidation Assessment Due Date:

Prepared By Department Signature Date

Approved By Department Signature Date

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