SOP for Development and Validation of Analytical Methods for Equipment Cleaning

Purpose

To lay down the procedure for the Development and Validation of Analytical Methods for equipment cleaning.

Scope

This procedure is applicable for the Development and Validation of Analytical Methods for equipment cleaning.

Responsibility

Senior Executive - QC

Accountability

Manager - QC

Procedure

• 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 is based on  the 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 method that defines the cleaning validation method. Prepare analytical method validation protocol as per the Annexure I 
• Assign the protocol number as per the Quality assurance SOP for Document Control, Issuance and Numbering System
• 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 validation as per cleaning validation method (Cleaning Validation Protocol).
• Based on the data, prepare a cleaning validation report as per the Annexure II

Annexure

Nil

Revision History

Nil

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