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Process Validation Guidance

The document provides guidance on process validation for medical devices. It defines key terms like process validation, installation qualification, operational qualification and performance qualification. It explains that process validation establishes that a process consistently produces products meeting requirements. It also discusses maintaining validated states, evaluating changes, and periodic revalidation. The overall document provides a framework to help manufacturers understand and implement process validation activities for medical devices.

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Rambabu komati - QA
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999 views28 pages

Process Validation Guidance

The document provides guidance on process validation for medical devices. It defines key terms like process validation, installation qualification, operational qualification and performance qualification. It explains that process validation establishes that a process consistently produces products meeting requirements. It also discusses maintaining validated states, evaluating changes, and periodic revalidation. The overall document provides a framework to help manufacturers understand and implement process validation activities for medical devices.

Uploaded by

Rambabu komati - QA
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Process Validation Guidance

GHTF/SG3/N99-10:2004
Study Group 3

Christine Nelson
U.S. Food and Drug Administration
Center for Devices and Radiological Health

June 2005 - SG 3 APEC Training - Bangkok, Thailand 1


Introduction
{ Definitions
{ How are processes validated?
{ What processes must be validated?
{ How to maintain state of validation
{ Revalidation

June 2005 - SG 3 APEC Training - Bangkok, Thailand 2


1.1 Purpose of Guideline

{ To assist manufacturers in
understanding quality
management system
requirements concerning
process validation

June 2005 - SG 3 APEC Training - Bangkok, Thailand 3


1.2 Scope of Guideline
{ Applicable to manufacturing,
servicing and installation
processes for medical devices
{ Does not cover verification of
design output or design
validation

June 2005 - SG 3 APEC Training - Bangkok, Thailand 4


What is Process
Validation?

June 2005 - SG 3 APEC Training - Bangkok, Thailand 5


Three Elements of Process Validation
1. Verify that equipment is installed and
operating properly (Installation
Qualification)
2. Develop process that can produce product or
result that meets all specifications
(Operational Qualification)
3. Verify that process can produce product or
result that meets all specifications
consistently over time (Performance
Qualification)

June 2005 - SG 3 APEC Training - Bangkok, Thailand 6


Steps in Validating a Process

1. Develop validation protocol


2. Conduct installation qualification
3. Conduct operational qualification
4. Conduct performance qualification
5. Analyze results and reach
conclusions

June 2005 - SG 3 APEC Training - Bangkok, Thailand 7


2. Definitions

June 2005 - SG 3 APEC Training - Bangkok, Thailand 8


2.4 Process Validation

{ Establishing by objective
evidence that a process
consistently produces a result
or product meeting its
predetermined requirements.

June 2005 - SG 3 APEC Training - Bangkok, Thailand 9


2.6 Verification

{ Confirmation by examination
and provision of objective
evidence that the specified
requirements have been
fulfilled.

June 2005 - SG 3 APEC Training - Bangkok, Thailand 10


2.5 Process validation protocol
{A document stating how
validation will be conducted,
including test parameters,
product characteristics,
manufacturing equipment, and
decision points on what
constitutes acceptable test
results.
June 2005 - SG 3 APEC Training - Bangkok, Thailand 11
2.1 Installation Qualification (IQ)
{ Establishing by objective evidence
that all key aspects of the process
equipment and ancillary system
installation adhere to the
manufacturer’s approved specification
and that the recommendations of the
supplier of the equipment are suitably
considered.

June 2005 - SG 3 APEC Training - Bangkok, Thailand 12


Some IQ Considerations
{ Equipment manufacturer’s
recommendations
{ Electricity: supply, reliability
{ Water: supply, pressure, quality
{ Air: pressure, quality
{ Calibration: schedule, documentation
{ Maintenance: schedule, procedures,
documentation, spare parts
June 2005 - SG 3 APEC Training - Bangkok, Thailand 13
2.2 Operational Qualification (OQ)

{ Establishing by objective
evidence process control limits
and action levels which result in
product that meets all
predetermined requirements.

June 2005 - SG 3 APEC Training - Bangkok, Thailand 14


Some OQ Considerations

{ Establish:

z Procedure
z Process control limits
z Output specifications
z Alert levels and action levels
z Specifications for components,
manufacturing materials

June 2005 - SG 3 APEC Training - Bangkok, Thailand 15


Some OQ Considerations

{ Some environmental conditions that


may affect process stability
z Temperature
z Humidity
z Light
z Particle count, contamination
z Other

June 2005 - SG 3 APEC Training - Bangkok, Thailand 16


2.3 Performance Qualification (PQ)

{ Establishing by objective
evidence that the process,
under anticipated conditions,
consistently produces a product
which meets all predetermined
requirements

June 2005 - SG 3 APEC Training - Bangkok, Thailand 17


Normal curve applied to histogram

Average - 3 Std. Dev. Average Average + 3 Std. Dev.

99.73%

June 2005 - SG 3 APEC Training - Bangkok, Thailand 18


UNSTABLE PROCESS
Total
Variation

e
m
Ti

June 2005 - SG 3 APEC Training - Bangkok, Thailand 19


STABLE PROCESS
Total
Variation

e
m
Ti

June 2005 - SG 3 APEC Training - Bangkok, Thailand 20


Maintaining a State
of Validation

June 2005 - SG 3 APEC Training - Bangkok, Thailand 21


6.1 Monitor and control process

{ Purpose: to ensure process remains


within established parameters under
anticipated conditions
{ Investigate deviations from
established parameters
{ Take corrective action
{ Consider whether revalidation is
necessary

June 2005 - SG 3 APEC Training - Bangkok, Thailand 22


6.2 Changes in process or product

{ Evaluate changes in process,


product, procedures, equipment,
personnel, environment, etc. to
determine effect of change
{ Is revalidation necessary?
{ How much revalidation is necessary
to assure process is capable and
stable?

June 2005 - SG 3 APEC Training - Bangkok, Thailand 23


Periodic revalidation

{ Consider periodic revalidation where


cumulative minor changes to process
and raw materials may eventually
affect process
{ Sterilization processes typically are
revalidated periodically (once a year)
as specified in voluntary standards

June 2005 - SG 3 APEC Training - Bangkok, Thailand 24


Some reasons for revalidation
{ Change in process that may affect quality
or validation status
{ Negative trend in quality indicators
{ Change in the product design that affects
the process
{ Process is moved within facility or
transferred from one facility to another
{ Change in the application of the process

June 2005 - SG 3 APEC Training - Bangkok, Thailand 25


Using historical data for validation
o Validation can be partially based on
accumulated historical manufacturing,
testing, control and other data
o Sources of historical data:
ƒ batch or lot records ƒ customer feedback
ƒ manufacturing log ƒ field failure reports
books ƒ service reports
ƒ test and inspection ƒ audit reports
results
ƒ generic feedback
ƒ control charts
June 2005 - SG 3 APEC Training - Bangkok, Thailand 26
Using historical data for validation

{ All appropriate data must have been


collected AND collected in a manner
that allows adequate analysis

{ Historical pass/fail manufacturing


data usually is not adequate

June 2005 - SG 3 APEC Training - Bangkok, Thailand 27


Summary
{ Definitions
{ How are processes validated?
{ What processes must be validated?
{ How to maintain state of validation
{ Revalidation

June 2005 - SG 3 APEC Training - Bangkok, Thailand 28

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