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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.
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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
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