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PERFORMANCE QUALIFICATION PROTOCOL - PQ Document Number:

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Confidential Document - CIQA Copyrights – Do not copy without authorization This document is property of CIQA and the copyrights laws apply, to limit its distribution, publication or verbal disclosure to anyone,

without the CIQA consent. Its distribution is prohibited by any means without the written permission of CIQA Inc.

Table of Contents 1 APPROVAL PAGE 3

2 PURPOSE 4

3 SCOPE 4

4 OUT OF SCOPE STATEMENT: 5

5 ROLES AND RESPONSIBILITIES 5

6 PROCESS DESCRIPTION 6

7 EQUIPMENT/ SYSTEM COMPATIBILITY AND EQUIVALENCY DESCRIPTION 7

8 PROCESS REQUIREMENTS – PREREQUISITES 8

9 REFERENCES 8

10 DEFINITIONS AND SYMBOLS/ ACRONYMS 9

11 ACRONYMS 13

12 DESIGN SPECIFICATION, USER REQUIREMENTS, DRAWING SPECIFICATIONS 14

13 STANDARD OPERATING PROCEDURES, TEST METHODS, MEASURING INSTRUCTIONS 14

14 VENDORS AND SUPPLIERS DESCRIPTION 15

15 CRITICAL QUALITY ATTRIBUTES CQA - TESTING AND SAMPLING DESCRIPTION 16

16 MEASURING INSTRUMENTS-SUITABILITY ASSESSMENT FOR CRITICAL QUALITY ATTRIBUTES 17

17 ENVIRONMENTAL CONDITIONS DESCRIPTION 18

18 OPERATORS, TECHNICIANS, INSPECTOR AND OTHER PERSONNEL INVOLVED 18

19 QUALIFICATION BACKGROUND: IMPACT ANALYSIS 19

20 VALIDATION APPROACH AND RATIONALE 19

21 VALIDATION WORST-CASE APPROACH 20

22 WORST-CASE RATIONALE SUMMARY 22

23 NUMBER OF LOTS 23

24 SAMPLE SIZE 24

25 ACCEPTANCE CRITERIA / PASSING RESULT AND SOURCE 25

26 RATIONALE FOR NOT MEASURES ALL QUALITY ATTRIBUTES 25

27 ASSESSMENT OF DOMINANT FACTORS TO THE PROCESS 26


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28 UNCONTROLLED OR NOISE FACTORS - NON-CRITICAL PROCESS PARAMETERS 28

29 OVERALL QUALIFICATION STRATEGY 29

30 FEASIBILITY STUDIES 30

31 GAUGE R & R STUDIES: INSTRUMENT ADEQUACY TEST 31

32 GENERAL EXECUTION PROCEDURE 32

33 INDIVIDUAL TEST PROTOCOL (ITPs) CHECKLIST 35

ITP-001 Equipment and Product Identification Verification 37

ITP 002 Equipment / System Instrumentation and Calibration Verification 38

ITP-003 Measuring and Test Instruments/ Equipment Calibration 39

ITP -004 Controlled Standard Operating Procedures, Work Instructions 40

ITP -005 Training Verification 41

ITP -006 Environmental Conditions Verification 42

ITP-007 Feasibility Study 43

ITP-008 Gauge R&R Study 44

ITP-009 Process Execution Verification and Testing 46

ITP-010 Process Data Collection & Statistical Calculation Results 47

ITP-011 Data Integrity Verification Test 48

ITP-012 Functional Verification – Sequence of Operation 49

35. PERFORMANCE TESTING COMPLETION CHECKLIST AND DISPOSITION 50

36. PROTOCOL ATTACHMENTS AND APPENDIXES 51

APPENDIX 1: PROTOCOL SIGNATURE IDENTIFICATION SHEET 52

APPENDIX 2: PROTOCOL DISCREPANCY/ DEVIATION LOG 53

APPENDIX 3: DISCREPANCY / DEVIATION REPORT FORM 54

APPENDIX 4: PROTOCOL ATTACHMENT LOG 55


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1. APPROVAL PAGE

Your signature indicates that you have reviewed this document and agree that it accurately and

completely represents the system and the necessary validation activities. You also agree that this

document complies with company validation procedures and instructions.

Prepared by: Author Printed Name Signature Date

Approved by: Quality Assurance

Printed Name Signature Date

HISTORY OF CHANGE

History of Change Version Number

Change Control Number

Section Author and

Owner

Reason for Revision (Description of Change)

LEGAL DISCLAIMER – TERMS AND CONDITIONS OF USE IMPORTANT: The information in this document is of a general nature, and should not be relied upon as

individual professional advice. If necessary, legal advice should be obtained from a legal practitioner

with expertise in the field of quality management law. Although every effort has been made to ensure

that the information in this document is complete, current and accurate, the CIQA Quality Management

Committee, any agent, author or contributor accepts no responsibility for any loss, damage or personal

injury that may result from the use of any material which is not complete, current and accurate if used

by other company nor purposes. Users should always verify historical material by making and relying

upon their separate inquiries before making any important decisions or taking any action based on this

information.

FURTHER ASSISTANCE CIQA Quality Specialists are available to give more advice and assistance on all quality management

matters. We can be contacted via our website at www.ciqa.net or email [email protected].

ADDITIONAL INFORMATION More document templates, information and guides can be found at the following websites:

www.ciqa.net/store or calling at 787-487-9235.

http://www.ciqa.net/

mailto:[email protected]

http://www.ciqa.net/store


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2. PURPOSE

This performance qualification (PQ) protocol aims to bring the documented evidence that the

equipment and products described in Table 1 have been verified and function together as expected,

according to company requirements specifications, intended use, and applicable manufacturer's

recommendations.

Equipment Name

& Description

Manufacturer Model / Asset

ID

Serial

number

Location

TABLE 1 - SYSTEM DESCRIPTION SUMMARY This document will identify the instructions to verify that the equipment have been challenged in its

final environment as per manufacturer’s specifications and corporate’s requirements for the products,

components and materials described in the following sections.

3. SCOPE

The scope of this protocol covers the products, components and materials described in table 2(a). In

addition, the scope includes the rational for the selection of the worse-case product(s) that shall be

tested in this qualification to establish the required evidence to demonstrate that it performs in

accordance with supplier’s recommendations, cGMP guidelines and company procedures and

requirements.

PRODUCT DESCRIPTION COMPONENT AND RAW MATERIALS

DESCRIPTION

Part

number

Name /

Description

Classification Part

Number

Name/

Description

Suppliers /

Vendors Name

TABLE 2(a) - PRODUCTS AND COMPONENTS DESCRIPTION SUMMARY


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4. OUT OF SCOPE STATEMENT:

Otherwise, established in the protocol scope, this protocol is not intended to challenge other products,

indirect equipment or supporting systems as: utilities, company network, cloud system, virtual network

operating systems, company data center, its servers and any other supporting devices or software

applications as described in table 3.

Out of Scope Statement

Requirements related to subassemblies or subcomponents are considered out of the scope of this

performance qualification protocol.

5. ROLES AND RESPONSIBILITIES

The following table details roles and responsibilities of the parties involved.

Deliverables Roles Responsibilities

Protocol, Execution and

Report

Validation Owner/

Qualification Project Leader

1. Issue protocol(s) and route for review and approval. 2. Coordinate availability of required resources (e.g., work-orders,

operators, support personnel, materials, processing and test equipment).

3. Assure all protocol discrepancies are properly investigated and documented.

4. Issue report(s) and route for review and approval. 5. Assure applicable regulatory and procedural requirements are

covered

Reviewers / Approvers and Quality Engineering Validation Leader

6. Review and approve documentation. 7. Support coordination of required resources (e.g., work-orders,

operators, support personnel, materials, process and test equipment).

8. Provide technical support during protocol execution and investigation of related discrepancies/ deviations.

9. Assure availability of required resources to complete the qualification/ validation study.


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6. PROCESS DESCRIPTION

This section describes the specific process and systems to be qualified.

Process Description

System Diagram or Figure


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Process Workflow Diagram

SUPPLIERS AND VENDORS CONTROLLABLE FACTORS LEVELS WORSE-CASE PRODUCTS

CRITICAL PROCESS PARAMETERS (CPP)

PROCESS NAME:

INPUTS: COMPONENTS / RAW MATERIALS

PROCESS EQUIPMENT

DESIGN, MFG & TEST

METHODS

MEASURING INSTRUMENT

OUTPUT: RESPONSE CQA CRITIAL QUALITY

ATTRIBUTES

ENVIRONMENTAL CONDITIONS

OPERATORS AND INSPECTORS UNCONTROLLABLE FACTORS: NOISE

7. EQUIPMENT / PROCESS COMPATIBILITY AND EQUIVALENCY DESCRIPTION

The equipment/process to be qualified can be compatible and equivalent to other equipment/process

in site. Since other similar equipment/process can perform equivalent tasks, then, these similarities

and compatibilities shall be documented as objective evidence provided. Describe how many

equipment/ processes of similar task and output shall be qualified under this protocol.

Equipment Machinery

/Process Description

Production Line

/ Equipment

Part

numbers

Equipment/Process Compatibility and

Equivalency Rational


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8. PROCESS REQUIREMENTS - PREREQUISITES

Consider the following prerequisites before initiate the execution of this performance qualification.

PROCESS DESCRIPTION PREREQUISITES

9. REFERENCES

This performance qualification will be executed in accordance with corporate policies, procedures,

regulatory compliance guidelines such as:

Document Ref. ID Document Title

21 CFR part 820 FDA regulations: Quality System Regulation

ISO 13485:2003 Medical devices -- Quality management systems -- Requirements

for regulatory purposes

GHTF Study Group 3 Global Harmonization Task Force: Quality Management System –

Process Validation Guideline.

Act 21 U.S.C.

351(a)(2)(B) 501(a)(2)(B) Code of Federal Regulations Title 21

21 CFR 211.110 Current Good Manufacturing Practice For Finished

Pharmaceuticals

FDA guideline “Process Validation: General Principles and Practices”


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10. DEFINITIONS AND SYMBOLS/ ACRONYMS

This section presents definitions of terms the symbols / acronyms specific to this document.

Term Definition

Ancillary

Auxiliary or supporting equipment attached or connected to primary equipment. Its

purpose is to support the operation of the primary equipment, although the primary

equipment can be operated without it.

Change

Management

System (CMS)

Change Management System, electronic system to request and approve changes.

Computer

System

Validation

Achieving and maintaining compliance with applicable GxP regulations and fitness

for intended use by adoption of principles, approaches, and lifecycle activities

within the framework of validation plans and reports; and the application of

appropriate operational controls throughout the life of the system.

Critical Process

Parameters

(CPP)

Critical process parameters (CPP) are key variables affecting the production process.

Examples of CPP are temperature, relative humidity, pressure, time, etc. CPPs are

factors that affect directly the process output, production operations and Critical

Quality Attributes CQA.

Critical Quality

Attributes

(CQA)

As defined in ICH International Conference Harmonization Guidance Q8, Critical

Quality Attributes (CQA) are “a physical, chemical, biological or microbiological

property or characteristics that should be within an appropriate limit, range, or

distribution to ensure the desired product quality.”

Typically, CQAs for a given product are defined early in development prospectively

based on the quality target product profile of the biotherapeutic, and progressively

refined as additional product knowledge is gained over time.

Examples of CQA are: % yield, dimensions, weight, content uniformity, impurities,

etc.

Discrepancy

Incongruity encountered under the scope of a protocol. Discrepancies should be

addressed with their resolution documented and approved by representatives

involved in the approval of the qualification/validation protocol. Each discrepancy

should be addressed, evaluated and a conclusion drawn as to acceptance or

rejection of the results


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Term Definition

Equipment Includes equipment, machines and tools with embedded software based controllers

used within the quality system to make a quality decision, unless otherwise verified.

Equipment

Performance

Report (EPR)

A pre-approved form intended to be used to provide instructions for testing of

equipment when repair or maintenance that could affect the functionality of the

equipment is required. The intention of the EPR is to verify and document that the

repairs performed to the equipment does not impact the validated state of the

equipment

Gage R&R Gage Repeatability & Reproducibility (R & R) Study

Individual Test

Procedure

A component of large qualification protocol which outlines, among other items,

related procedure steps and acceptance criteria for a test that is designed to

challenge a single or set of requirements.

Infrastructure An underlying base or foundation including basic facilities, equipment and

installation needed for the functioning of system services.

Installation

Qualification

(IQ)

Establishing by objective evidence that all key aspects of the systems and processes,

and ancillary system installation adhere to the manufacturer’s (ZMBV’s) approved

requirement specification, and that the recommendations of the supplier of the

equipment are suitably considered (GHTF-SG3 N99).

Intended Use Company’s defined use for individual equipment / systems, processes and

inspection test methods.

Objective

Evidence

Data supporting the existence or verity of something (i.e., requirements and

specifications met). It may be obtained through observation, measurement, test,

or by other means. Objective evidence should be included in the executed

protocols.

Operational

Qualification

(OQ)

Documented plan for the inspection/tests to verify that the key parameters of a

facility, utility, equipment, and computer system perform as intended against

predetermined acceptance criteria.


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Term Definition

Performance

Qualification

The Performance Qualifications is a collection of test cases used to verify that a

system behaves as expected under simulated or real-world conditions

demonstrating that the process or equipment is consistent over time with the user’s

requirements and functional requirement specifications.

The performance qualification testing must aim to challenge and fulfill the pre-

established User Requirements Specification (or Functional Requirements

Specification).

The PQ is the final step of qualifying a system, equipment or process to establish

scientific evidence that the process is reproducible and will reliably deliver quality

products. A manufacturer must successfully complete PQ before commencing

commercial distribution of the drug product.

Some people confuse performance qualification with process validation.

Performance qualification is just one activity of the whole process of validation

activities required to be done by the FDA statutory and regulatory requirements for

process validation.

Protocol A written plan stating how an equipment/system qualification and /or process

validation will be conducted.

Qualification

The process used to demonstrate the ability of an equipment or system to fulfill

specified requirements.

NOTE: For the purpose of this document, “Qualification” is also implied when

referring to “Validation/ Re-validation” as general terms

Qualification /

Validation

Team

Consist of, at least, a Manufacturing Engineer, Quality Engineer and Manufacturing

Supervisor responsible for the area / product impacted. The Manufacturing

Engineer acts as the team leader.

Requirement

A condition of capability needed to achieve an objective; one that must be met or

possessed by a system or process to satisfy a contract, standard, specification, or

other formally imposed document.

Specification A document that specifies, in a complete, precise, verifiable manner, the

requirements, design, or other characteristic of a system or process.


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Term Definition

System

A composite, at any level of complexity, of personnel, procedures, materials, tools,

equipment, facilities and software. The elements of this composite entity are used

together in the intended operation or support environment to perform a given task

or achieve a specific purpose, support or mission requirement

Test Method

Validation

(TMV)

A validation activity to demonstrate that a test method is appropriate for its

intended use and is capable of producing accurate, repeatable, and reproducible

results over the entire range of measurement

Validation A confirmation by examination and provision of objective evidence that the

particular requirement for a specific intended use can be consistently fulfilled.

Validation Plan Written document that details what activities will be performed in order to validate

and/or qualify a system.

Verification Confirmation by examination and provision of objective evidence that specified

requirements have been fulfilled.

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11. ACRONYMS

Acronym Associated Term

BU Business Unit

CMS Change Management System

CPP Critical process parameters

CQA Critical Quality Attributes - product output quality or measured process response

CSV Computer System Validation

CSVR Computer System Validation Report

EPR Equipment Performance Result

EHS Environmental, Health and Safety

GxP

Equivalent to and an abbreviation for Good Clinical Practices (GCP), Good

Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) considered

together.

IQ Installation Qualification

IQR Installation Qualification Report

ITP Individual Testing Procedure

MC Management Change Request

N/A Not Applicable

OCP Operating Control Procedure

OQ Operational Qualification

SOPs Standard Operating Procedures

TBD To be determined

TMV Test Method Validation

VP Validation Plan

You can buy this validation template document in MS Word format that is completely editable, ready to fill, and adapt its use according to your corporate procedures.

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