1.0
PURPOSE:
1.1
2.0
SCOPE:
2.1
3.0
Senior Executive – QC
ACCOUNTABILITY:
4.1
5.0
This procedure is applicable for Development and Validation of Analytical
Method for equipment cleaning.
RESPONSIBILITY:
4.1
4.0
To lay down the procedure for development and validation of analytical
method for equipment cleaning.
Manager - QC
PROCEDURE:
5.1
Review the written cleaning procedure to determine what cleaning agents are
used, such as water, alcohol, etc.
5.2
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 following
table.
ANALYTICAL TECHNIQUE SELECTION FOR CLEANING VALIDATIONS
Target Analyte
UV-Visible active drug
where no other components
of the product are UVVisible active
UV-active drug where other
components of the product
are UV active
Method
UV spectroscopy
Reason
1. Sensitivity
2. Selectivity because of
knowledge of matrix
HPLC
UV inactive drugs that are
volatile or for which
volatile derivatives can be
prepared
GC
UV inactive drugs that are
acidic or basic and for
which UV, HPLC, AA and
GC are not applicable
Titration
1. Sensitivity, if the correct
wavelength is chosen.
2. Selectivity based on
separation of analyte from
matrix.
1. Sensitivity if correct detector
and detector parametes are
chosen
2. Selectivity if proper
chromatography is employed
1. Sensitivity if dilute enough
titrants are used (0.001N or
0.001N)
5.3
Develop and validate the method of choice as per following table.
Analytical Technique
UV spectroscopy
Analytical Technique
HPLC
GC
Minimum Validation Components
Precision
Linearity
Limit of detection
Limit of quantitation
Swab recovery
Rugged ness
Solution stability
Minimum Validation Components
Linearity
Accuracy
Limit of detection
Limit of quantitation
Specificity
Solution stability
Linearity
Accuracy
Titration
Limit of detection
Limit of quantitation
Specificity
Solution stability
Limit of detection
Limit of quantitation
Solution stability
5.3
Prepare an analytical method that defines cleaning validation method.
5.4
Prepare analytical method validation protocol as per the Annexure I
5.5
Assign the protocol number as per the Quality assurance SOP No.: xxxxx
5.6
Carry out the sampling for swab recovery as per sampling SOP no. xxxxx
5.7
Carry out the validation as per cleaning validation method.
5.8
Based on the data, prepare a cleaning validation report as per the Annexure II
END OF DOCUMENT