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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
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
3.4 Revalidation
Validation for a process that has been previously validated.
4.0 Responsibilities
5.0 References
Production Equipment
Product Program Management Cycle
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
• 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.
• 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.
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:
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.