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SOP for Development and Validation of Analytical Method for equipment cleaning

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

Scope
This procedure is applicable for Development and Validation of Analytical Method 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 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



Annexure
Nil

Revision History
Nil

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