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[Company Name]

[Company Group, Division, Location]

Document Title: Process Validation


Document Number: [Document Number]
Document Filename: [Document Filename]

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Revision Revision DCO/ECO Revision


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DRAFT DD/MM/Y YY-00000 Draft Author Name
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1.00 DD/MM/Y YY-00000 Initial Release Author Name
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COMPANY PROPRIETARY AND CONFIDENTIAL


[Company Name] Process Validation
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Table of Contents

Table of Contents...................................................................................................................................................1

1.0 Purpose..............................................................................................................................................................2

2.0 Scope.................................................................................................................................................................2

3.0 Definitions.........................................................................................................................................................2
3.1 Process Validation..................................................................................................................................2
3.2 Prospective Validation...........................................................................................................................2
3.3 Retrospective Validation........................................................................................................................2
3.4 Revalidation............................................................................................................................................2

4.0 Responsibilities.................................................................................................................................................2
4.1 Design Engineering................................................................................................................................2
4.2 Manufacturing Engineering....................................................................................................................2
4.3 Program/Project Management................................................................................................................2
4.4 Product Development Team...................................................................................................................2
4.5 Quality Assurance..................................................................................................................................2

5.0 References.........................................................................................................................................................2

6.0 Procedure...........................................................................................................................................................3
6.1 When Process Validation is Required....................................................................................................3
6.2 When Process Validation is Recommended..........................................................................................3
6.3 Retrospective Validation........................................................................................................................3
6.4 Prospective Validation...........................................................................................................................3
6.5 Elements of the Process Validation.......................................................................................................3
6.6 Revalidation............................................................................................................................................4

7.0 Documentation..................................................................................................................................................4

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 1 of 4


[Company Name] Process Validation
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

1.0 Purpose
This procedure defines process validation methods for manufacturing processes.

2.0 Scope
This procedure applies to manufacturing processes at all facilities of [Company Name].

3.0 Definitions

3.1 Process Validation


Establishment by objective evidence that a process consistently produces a result meeting
predetermined specification.

3.2 Prospective Validation


Validation conducted prior to introduction of a new product or process.

3.3 Retrospective Validation


Validation conducted on an existing process using accumulated data.

3.4 Revalidation
Validation for a process that has been previously validated.

4.0 Responsibilities

4.1 Design Engineering


Responsible for the design and design support for the product being manufactured. Design
Engineering also writes the product design documentation.

4.2 Manufacturing Engineering


Responsible for design and support of manufacturing processes. Manufacturing Engineering also
writes the manufacturing process documentation. Manufacturing Engineering is responsible for
initiation of the process validation activities, validation protocol, performance of the validation
tests, and writing reports.

4.3 Program/Project Management


Responsible for coordinating process validation reviews and approvals, obtaining the proper
approval signatures, and filing of process validation records. Program/Project Management also
forms the Product Development Team.

4.4 Product Development Team


Responsible for review and approval of the protocol, monitoring the performance of the
validation tests, and review and approval of the validation report. The product development
team also manages development activities related or subsequent to process validation.

4.5 Quality Assurance


Responsible for monitoring the effectiveness of this procedure consistent with recognized
standards.

5.0 References
Production Equipment
Product Program Management Cycle

Useful Technical References

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 2 of 4


[Company Name] Process Validation
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

FDA, CDRH, Quality System Manual, Section 4: Process Validation, 1997 FDA, CDRH, Guideline on
General Principles of Process Validation, 1997 Kane, V. (1986). Process Capability Indices. J. Quality
Technology (18-1) 41.

6.0 Procedure

6.1 When Process Validation is Required


Process validation is required when any of the events listed below occur:

• The Pre-Production Phase of the program management cycle.


• Installation of new processes or equipment, when it is determined that validation is required.
• Results of a manufacturing process that affects quality cannot be routinely determined by
inspection or testing.
• Design changes significantly affect a validated manufacturing process.

6.2 When Process Validation is Recommended


Process validation is recommended when any of the events listed below occur:

• Yearly if under continuous operation during or after the Pre-Production phase of the
program management cycle.
• A manufacturing process produces excessive defects.
• Evaluation or troubleshooting of a pass/fail process.
• Customer complaints or a quality investigation identify the manufacturing process as a
possible cause for defects.

6.3 Retrospective Validation


Retrospective validation is used when historical data is available for existing manufacturing
processes. Types of useful data include design drawings and specifications, operating procedures
and work instructions, manufacturing instructions, inspection reports, production logs,
production test data, material review reports, service records, customer complaints, and audit
reports. Retrospective validation may not be feasible if accumulated data is incomplete or
inadequate.

6.4 Prospective Validation


Prospective validation is used when insufficient data is available for a manufacturing process, in
situations such as installation of new equipment, qualification of new process performance, or
processes which are not routinely monitored.

6.5 Elements of the Process Validation


The process validation should include the items listed below. For a retrospective validation,
procedure and document numbers may be cited if it is known that the data contained is
sufficient.

• Identification of the process to be validated.


• Identification of the products or assemblies manufactured using the process.
• Events that have indicated the need for validation or revalidation.
• Complete description of the process.
• Relevant specifications for the product, components, materials, and the environment.
• Assumptions about work shifts, operators, equipment and components.
• Identification of operators and required operator qualifications.
• Identification of utilities and their quality.
• Identification of equipment to be used in the process.
• Consideration for calibration, maintenance and repairs.
• Product characteristics to be monitored and the method for monitoring.

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[Company Name] Process Validation
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

• Process parameters; to be controlled and monitored and methods for controlling and
monitoring.
• Any subjective criteria used for evaluation.
• Definition of what constitutes nonconformance for measurable and subjective criteria.
• Information about sample size, length, and duration of the study.
• Any special controls or conditions placed on preceding processes during the validation.
• Statistical methods used for data analysis.
• Criteria for a successful validation.
• Measurement results, observations, conclusions, and recommendations.

For validations that involve installation/qualification of equipment or processes, the process


validation should include:

• Verification that the equipment design meets specified requirements.


• Identification of equipment features critical to the outcome of the process.
• Identification of supplied documentation.
• Establishment or verification of operating procedures.
• Establishment or verification of calibration or maintenance requirements.

6.6 Revalidation
Revalidation of a manufacturing process that had been previously evaluated need not include all
of the elements listed above. The revalidation report should include:

• Identification of the process to be validated.


• Identification of the products or assemblies manufactured using the process.
• Reason for revalidation.
• Identification of previous validation reports where pertinent information is contained.
• Detailed information about any element which had changed since the last validation.
• Measurement results, observations, conclusions, and recommendations.

7.0 Documentation
Records of validation activities should be issued as Technical Reports and retained in the Design
History File. Reviews shall be held and review records should include dates and signatures of the
individuals who review and approve the validation.

For a validated process used in manufacturing, a qualified operator must perform the process.

Records containing manufacturing data should be retained in the appropriate Device History Record.

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