- Review the written cleaning procedure to determine what cleaning agents are used, such as water, alcohol, etc.
- From information about the target analyte (least soluble active drug substance), determine what kind of analytical procedure will be used to measure any residual of the target analyte after cleaning. As per the following table.
|
ANALYTICAL TECHNIQUE SELECTION FOR
CLEANING VALIDATION |
||
|
Target Analyte |
Method |
Reason |
|
UV – Visible active drug where no
other components of the product are UV – Visible active. |
UV Spectroscopy |
· Sensitivity · Selectivity
because of knowledge of matrix |
|
UV – Visible active drug where
other components of the product are UV – Visible active. |
HPLC |
· Sensitivity,
If the correct wavelength is chosen. · Selectivity
based on separation of analyte from analyte. |
|
UV inactive drugs that are
volatile or for which volatile derivatives can be prepared. |
GC |
· Sensitivity,
If the correct detector and detector parameters are chosen. · Selectivity
if proper chromatography is employed. |
|
UV inactive drugs that are acidic
or basic and for which UV, HPLC, AA and GC are not applicable. |
Titration |
· Sensitivity,
if dilute enough titrants are used. (0.01 N or 0.001N)
|
- Develop and Validate the method of choice as per the following table.
|
Analytical Technique |
Maximum Validation Component |
|
UV Spectroscopy |
·
Precision ·
Linearity ·
Limit
of Detection ·
Limit
of Quantitation ·
Swab
Recovery ·
Ruggedness ·
Stability |
|
HPLC |
·
Linearity ·
Accuracy ·
Limit
of Detection ·
Limit
of Quantitation ·
Specificity ·
Stability |
|
GC |
·
Linearity ·
Accuracy ·
Limit
of Detection ·
Limit
of Quantitation ·
Specificity ·
Stability |
|
Titration |
·
Limit
of Detection ·
Limit
of Quantitation ·
Stability |
- Prepare an analytical methods that defines cleaning validation method.
- Prepare an analytical method validation protocol as per SOP analytical method validation.
- Assign the protocol number as per SOP.
- Carry out the sampling for swab recovery as per sampling SOP for Sampling and Testing of Equipment wash water and Swab sampling.
- Carry out the cleaning validation as per cleaning validation method.
- based on the data prepare cleaning validation report.
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