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Performance Qualification Template: Insert Logo Here

This performance qualification protocol outlines testing to qualify equipment. It defines responsibilities of those conducting testing, provides details of the equipment and nature of testing, and lists test sections that must be completed for approval. Acceptance criteria are established by regulations and standards, with some custom criteria explained. Upon completing all mandatory test sections, the qualification will be approved.
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0% found this document useful (0 votes)
1K views14 pages

Performance Qualification Template: Insert Logo Here

This performance qualification protocol outlines testing to qualify equipment. It defines responsibilities of those conducting testing, provides details of the equipment and nature of testing, and lists test sections that must be completed for approval. Acceptance criteria are established by regulations and standards, with some custom criteria explained. Upon completing all mandatory test sections, the qualification will be approved.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Document ID: <PQ001>

Insert logo here


Revision No.: <nn>
Performance Qualification Template Effective Date: <date>

Performance Qualification Template

Document information, authorship and approvals


Author signs to confirm technical content
Prepared by: Job title: Signature: Date:

Subject matter expert reviewer signs to confirm technical content


Reviewed by: Job title: Signature: Date:

Quality representative signs to confirm document complies with quality management system
Authorised by: Job title: Signature: Date:

Document is current if front page has “Controlled copy” stamped Page 1 of 14


Document ID: <PQ001>
Insert logo here
Revision No.: <nn>
Performance Qualification Template

Contents
1. Introduction ......................................................................................................................3
2. Scope .................................................................................................................................3
2.1. Exclusions .................................................................................................................................3
3. Responsibilities .................................................................................................................3
3.1. Preparer ....................................................................................................................................3
3.2. Verifier ......................................................................................................................................3
3.3. Quality Approval ........................................................................................................................3
4. Qualification Description ..................................................................................................3
4.1. Equipment/System Details ..........................................................................................................3
4.2. Qualification Details ...................................................................................................................4
4.3. Justifications .............................................................................................................................4
5. Test Section Details ..........................................................................................................4
6. Qualification Instructions .................................................................................................5
6.1. Data Collection ..........................................................................................................................5
6.2. Interim Progression ...................................................................................................................5
7. Deviations & Deficiencies..................................................................................................5
8. Protocol Approval Requirements ......................................................................................6
8.1. Acceptance Criteria ....................................................................................................................6
8.2. Reporting ..................................................................................................................................6
9. Referenced Documents .....................................................................................................6
10. Definitions .........................................................................................................................6
11. Test Section 1 – Signature Register..................................................................................7
12. Test Section 2 – Test Instrument Details .........................................................................8
13. Test Section 3 – Performance Testing ..............................................................................9
14. Test Section 4 – Exception Reports ................................................................................10
15. Test Section 5 – Progression Approval ...........................................................................11
16. Test Section 6 – Attachments .........................................................................................13

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Document ID: <PQ001>
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Performance Qualification Template

1. Introduction
This Performance Qualification (PQ) protocol describes in detail the activities required to
execute the PQ phase of qualification of the Performance Qualification Template at
Company Name’s [Company Address] manufacturing facility. It defines testing and
documentation required to ensure that the equipment performs in accordance with
process, company and regulatory requirements.

2. Scope
This protocol applies to the Performance Qualification Template. It considers
equipment/system performance under normal operating conditions.

2.1. Exclusions
List only items specific to the scope which could reasonably expect to part of the testing.
Refer to the alternative testing documentation or state justification if not tested.

3. Responsibilities
Personnel executing and/or assisting with the execution of the Performance Qualification
are recorded in the Signature Register in Test Section 1. Persons signing the front page of
this protocol are confirming compliance with the information below:

3.1. Preparer
The preparer shall be the primary author of the document, or a delegate with an
appropriate level of understanding of the technical content of the document. The preparer
signs to confirm that, to their knowledge, the document is complete, complies with the
validation plan and is free from errors.

3.2. Verifier
The verifier shall be the system owner or a delegate with an appropriate level of
understanding of the functionality of the equipment/system The verifier signs to confirm
that, to their knowledge, the document fulfils all relevant testing requirements, is logical
and executable and is free from errors.

3.3. Quality Approval


The quality approver shall be the Quality Manager or a delegate with an appropriate level
of understanding of the quality systems relevant to this protocol. The quality approver
signs to confirm that the document complies with relevant quality systems (including the
VMP), can be adequately resourced in the time frame anticipated for execution and is free
from errors.

4. Qualification Description

4.1. Equipment/System Details


Provide a brief overview of the equipment/system

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Performance Qualification Template

4.2. Qualification Details


Provide a summary of the ‘how’ of the execution:
• room conditions, commissioned, cleaned, in routine operation, etc.
• the type of testing – simulated, ‘live’ testing, placebo, etc.
• Number of people involved and whether they active or passive
• Estimated duration of testing if known
• Information on multiple or single trials
• Any other general information that may be useful to the reader to understand
what will occur during the testing phase

4.3. Justifications
Acceptance criteria for most qualification tests have been established in accordance with
regulatory requirements, internal policy standards and established industry standards.
In some cases, it is necessary to define criteria without these established references. Any
instances of these criteria in this protocol are explained below:

Test Reference Criteria Explanation

5. Test Section Details


The testable sections of this protocol are listed below. All sections marked as mandatory
or applicable must be completed prior to final approval of the qualification.
The Test Instrument section may not be applicable for some qualifications. In such
circumstances, a brief statement as to why must be included. The test section itself
should be left in, but the relevant table should be deleted and a statement of justification
inserted in its place.

Test Section Applicable? Reason if Omitted

1. Signature Register Mandatory

2. Test Instrument Details Yes N/A

3. Performance Testing Mandatory

4. Exception Reports Mandatory

5. Progression Approval Mandatory

6. Attachments Mandatory

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Performance Qualification Template

6. Qualification Instructions

6.1. Data Collection


The Performance Qualification will comprise:
1. The approved copy of this protocol completed as indicated in clear handwriting and of
attached documents, annotated where indicated in this protocol and listed in Test
Section 6.
2. The completed Progression Approval (Test Section 5), as described in Section 6.2.
Additionally, the following specific data collection instructions must be followed:
• All persons entering data in this protocol must be identified in Test Section 1.
• All handwritten entries must be made in blue or black ink.
• Corrections to handwritten data must be made with a single strikeout, initial and date.
• Data entry spaces must be populated or marked not applicable (N/A)
• Corrections and ‘N/A’ markings must be accompanied by a brief reason where the
reason is not self-evident. The entry must be initialled and dated.
• "Ticks" or "crosses" are not permissible. Appropriately descriptive words and figures
must be used to complete data entry spaces.
• The executor should make any comments arising from the checks in the comment
section shown. Comments should be continued in an attachment if necessary.
• Individual comments must be initialled and dated.
• All sections should be completed by the executor as soon as possible after completion
of the test.

6.2. Interim Progression


Qualification may move to the next stage, or the equipment/system handed over to the
owner for routine use on completion of the requirements listed in Test Section 5. These
requirements are the pre-requisites for the next phase, and may not include all testing.
The Interim Progression Approval must be completed and approved by the equivalent
level of authorisation to the protocol.
At the completion of all testing requirements, the Progression Approval shall be updated
to reflect the final status of the qualification.

7. Deviations & Deficiencies


Deviations and deficiencies observed during the execution of the protocol must be
addressed in an exception report. The exception reports shall include the following
information:
• Details of the protocol
• The relevant phase of testing, and the date which the exception was observed
• A description of the exception
• A root cause analysis
• Corrective action(s) if any
• Final outcome of the exception

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Performance Qualification Template

Exception reports shall be approved by the Quality Manager or appropriate delegate.


Exception reports shall be numbered [Subject]-ERXX, where XX represents a sequential
number starting at 01. All exception reports shall be listed in Test Section 4.

8. Protocol Approval Requirements

8.1. Acceptance Criteria


The executed protocol must meet all requirements defined in this protocol. Any deviations
from the requirements and instructions defined within must be addressed through
exception reports.
The specific acceptance criteria for testing are defined within each test section. Deviations
from the instructions in the appendices must also be addressed through exception
reports.
When all criteria, requirements and instructions have been met, or any exceptions have
been adequately justified through exception reports, the final qualification report may be
approved and issued.

8.2. Reporting
When the qualification protocol is complete, including the completion and approval of all
exception reports, the results shall be summarised in a Validation Summary Report (VSR).
It shall summarise the results of the executed protocol relative to acceptance criteria,
detail exceptions; discuss relevant issues arising from the execution and make a
concluding statement regarding the success of the qualification exercise. The report shall
have an equivalent level of approval to the protocol.
The report may combine the results of multiple qualifications from the same project.

9. Referenced Documents
Ensure the following documents are read and understood before executing this protocol

Document Number Document Title

10. Definitions
Term/abbreviation Definition

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Performance Qualification Template

11. Test Section 1 – Signature Register


Instructions & Criteria

Complete table for each person involved in performing or documenting the qualification, including reviewers.
Acceptance Criterion: All personnel involved have been identified and acknowledged their role.

Name Title Department/Company Role in Qualification Signature Initials

Comments:

Acceptance Criteria Met Related Exception Reports Initial and Date Checked by Initial and Date
Y/N
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12. Test Section 2 – Test Instrument Details


Instructions & Criteria

Complete the table for all reference instruments used to confirm PQ test results, and confirm calibration status before use.
Acceptance Criteria: All identified test instruments have current calibration at the time of use.

Test Spec Instrument Calibration


Instrument description Certification Location Initial & Date
No. Ref. ID Expiry

2.1 U34

2.2 N/A

2.3

2.4

2.5

2.6

Comments:

Acceptance Criteria Met Related Exception Reports Initial and Date Checked by Initial and Date
Y/N
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13. Test Section 3 – Performance Testing


Instructions & Criteria

Execute the performance tests to ensure that system/equipment operates in accordance with specifications and regulatory requirements. Where additional
raw data is generated, attach it to the qualification protocol and list is Test Section 6. Where multiple trials are performed, copy this section as required.
Acceptance Criteria: Refer to individual tests.

Test Spe Test Description/Procedure Acceptance Criteria Actual Result Pass/ Initial & Date
No. c Fail
Ref.

3.1 U22

3.2 U27

3.3 N/A

3.4

Comments:

Acceptance Criteria Met Related Exception Reports Initial and Date Checked by Initial and Date
Y/N
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14. Test Section 4 – Exception Reports


Instructions

List all exception reports generated during this qualification. Provide a brief summary of the information in the full reports.

Closed
Exception Brief Description of Initial &
Brief Description of Exception Brief Description of Cause (Yes/No
Report No. Resolution Date
)

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Performance Qualification Template

15. Test Section 5 – Progression Approval


Instructions

This progression approval lists the minimum requirements for progression to the next phase of use for the equipment/system. Confirm that the progression
requirement has been met, or non-compliance has been adequately justified within an approved exception report. Provide justification for why progression
is acceptable prior to completion of all sections.
On completion of all tests and exceptions, completion the Final Disposition section of the certificate.
If all tests and exceptions are completed prior to progression, strike out the progression justification and approvals section.

Progressing To CV / PV / Routine Use (Circle One) or Other: _________________________

Approved Exception Initial and


Protocol Test Section Test number(s) Progression Requirement Result
Report No.(s) Date

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Performance Qualification Template

Instructions

This progression approval lists the minimum requirements for progression to the next phase of use for the equipment/system. Confirm that the progression
requirement has been met, or non-compliance has been adequately justified within an approved exception report. Provide justification for why progression
is acceptable prior to completion of all sections.
On completion of all tests and exceptions, completion the Final Disposition section of the certificate.
If all tests and exceptions are completed prior to progression, strike out the progression justification and approvals section.

Progression Justification

Operations Approval for Progression Quality Approval for Progression

Name Sign & Date Name Sign & Date

Final Disposition of Qualification (complete after qualification finalised)

Operations Approval of Completed Qualification Quality Approval of Completed Qualification

Name Sign & Date Name Sign & Date

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Performance Qualification Template

16. Test Section 6 – Attachments


Instructions

List and describe all attachments to the qualification report here.

Attachment No. Attachment Description

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Performance Qualification Template

Document Information
Revision History
Revision Modified by Change Description of Change
Control No.
01

Complete the above fields for each revision of this document. Ensure that there is
sufficient description of changes so that the change history of this document can
be followed. Additional columns can be added to include document/change
tracking numbers generated by your company’s systems if required (eg. change
control).

Associated forms and procedures


Doc. No. Document Title

List all controlled procedural documents referenced in this document (for example,
policies, procedures, forms, lists, work/operator instructions

Associated records
Doc. No. Document Title

List all other referenced records in this document. For example, regulatory
documents, in-house controlled documents (such as batch record forms, reports,
methods, protocols), compliance standards etc.

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