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Process Validation Guidance
GHTF/SG3/N99-10:2004
Study Group 3
Introduction
Purpose Scope of SG3/N99
What is process validation?
How are processes validated?
What processes must be validated?
How to maintain state of validation
Revalidation
GHTF SG3 Training : Toronto May 14-16, 2009 2
SG3/N99- 10 (Edition 2) Quality
SG3/N99- 10 (Edition 2) Quality
Management Systems
Management Systems
- Process Validation Guidance.
- Process Validation Guidance.
1.1 Purpose
To assist manufacturers in
understanding quality management
system requirements concerning
process validation
GHTF SG3 Training : Toronto May 14-16, 2009 3
SG3/N99- 10 (Edition 2) Quality
SG3/N99- 10 (Edition 2) Quality
Management Systems
Management Systems
- Process Validation Guidance.
- Process Validation Guidance.
1.2 Scope
Applicable to manufacturing,
servicing and installation processes
for medical devices
Does not cover verification of
design output or design validation
GHTF SG3 Training : Toronto May 14-16, 2009 4
SG3/N99- 10 (Edition 2) Quality
SG3/N99- 10 (Edition 2) Quality
Management Systems
Management Systems
- Process Validation Guidance.
- Process Validation Guidance.
2.4 Process Validation (Definition)
Establishing by objective evidence that
a process consistently produces a result
or product meeting its predetermine
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