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2 Process Validation
2 Process Validation
MDV-Solve
Process Validation - Basics
Definition:
“Where the result of a process cannot be fully verified
by subsequent inspection and test, the process shall
be validated with a high degree of assurance and
approved according to established procedures.”
S Redesign product
or process
Is verification sufficient N N
& Cost effective ?
Y
Verify and Control Validate
the process the process
MDV-Solve 4
Process Validation - Basics
✓Definition
Establish documented evidence which provides a high
degree of assurance that a specific process will
consistently produce a product meeting its
predetermined specifications and quality attributes.
Establish (21CFR820.3(k)) :
- define : Prepare a validation protocol
- implement : Execute the protocol
- document : Gather evidence
MDV-Solve 5
Process Validation - Basics
✓Definition
Establish documented evidence which provides a high
degree of assurance that a specific process will
consistently produce a product meeting its
predetermined specifications and quality attributes.
Evidence :
- “What’s not documented is not done...”
- ...but what’s not documented properly is useless...
MDV-Solve 6
Process Validation - Basics
✓Definition
Establish documented evidence which provides a high
degree of assurance that a specific process will
consistently produce a product meeting its
predetermined specifications and quality attributes.
MDV-Solve 7
Process Validation - Basics
✓Definition
Establish documented evidence which provides a high
degree of assurance that a specific process will
consistently produce a product meeting its
predetermined specifications and quality attributes.
consistently produce :
- Based on statistics
- Gauss-curve
MDV-Solve 8
Process Validation - Basics
✓Definition
Establish documented evidence which provides a high
degree of assurance that a specific process will
consistently produce a product meeting its
predetermined specifications and quality attributes.
predetermined specifications :
- Process description
- Critical process parameters
- Acceptance criteria
MDV-Solve 9
Process Validation - Basics
99.73%
The standard deviation represents the typical distance a unit is from the average
For the normal curve, 99.73% of the units fall within 3 standard deviations of the average.
Histogram of data
LSL USL
3
Number
2
0
95 100 105
Length (cm)
The width of the histogram represents the variation. interest is whether the histogram is
properly centered and whether the histogram is narrow enough to easily fit within the
specification limits. The center of the histogram is estimated by calculating the average of
the 12 readings
Example:
one operation involves cutting wire into 100 cm lengths. The tolerance is
100 5 cm. A sample of 12 wires is selected at random and the
following results obtained:
98.7, 99.3,100.4,97.6,101.4,102.0, 100.2, 96.4,
103.4,102.0,98.0,100.5
UNSTABLE PROCESS
Total
Variation
e
m
Ti
Example unstable process. The process is constantly changing. The average shifts up and
down. The variation increases and decreases. The total variation increases due to the
shifting.
MDV-Solve 21
Process Validation - Basics
STABLE PROCESS
Total
Variation
e
m
Ti
Example stable process. Stable processes produce a consistent level of performance. The
total variation is reduced. The process is more predictable
MDV-Solve 22
Process Validation - Basics
P R O C E SS C A P A B IL ITY
CA P AB LE
NOT Spec
L im its
C A P A B LE
e
m
Ti
Once a consistent performance has been achieved, the remaining variation
must be made to safely fit within the upper and lower specification limits.
Such a process is then said to be stable and capable.
MDV-Solve 23
Process Validation - Basics
Control Chart
MDV-Solve 24
Process Validation - Basics
Final report
At the conclusion of validation activities, a final
report should be prepared.
summarize and reference all protocols and results.
derive conclusions regarding the validation status of the
process.
The final report should be reviewed and approved by the
validation team and appropriate management
Sample protocols
01/04/202
Fayez Abou Hamad 27
0
THANK YOU
01/04/202
Fayez Abou Hamad 28
0