SOP for Analysis of Rinse Sample

OBJECTIVE

To define a standard operating procedure for the analysis of rinse samples.

SCOPE

The procedure is applicable for the analysis of the rinse samples sent by the Production Department

RESPONSIBILITY

Quality Control Department: 

To carry out this procedure as defined.

Quality Control Head: 

To ensure proper and timely execution of the procedure.

Review and Implementation of SOP

Quality Assurance Head:

Approval of the SOP

Overall responsible for implementation.

ACCOUNTABILITY

Head Quality Control

ABBREVIATIONS 

SOP - Standard Operating Procedure

QA - Quality Assurance

e.g. - Example

cGMP - Current Good Manufacturing Practices

QC - Quality Control

DEFINITIONS

• Specification: A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service.
• cGMP: Current Good Manufacturing Practices (cGMP) is defined as that part of quality assurance that ensures products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
• Owner: The author is the owner of the SOP. He/She is responsible for the accuracy/correctness of the SOP
• Approval: Written sanction or delegated power of opinion because of recognized knowledge, expertise, and hierarchical authority. This is the act of bringing the SOP into force.

PROCEDURE

• Collect the sample of final rinsing of the equipment along with the requisition for analysis of Rinse sample (in duplicate).
• Operate the Spectrophotometer as per the standard operating procedure for Spectrophotometer and read the absorbance of the sample solution in the Region 230nm to 360 nm.
• If the absorbance is a straight line or without any peaks, get the absorbance pattern printed out or make a note of the same, mentioning the sample details, and put the remark as ‘Sample Complies for Rinse Testing ‘.
• Return the requisition to the Production department with remarks.
• If the absorbance is not as mentioned at (6.3), inform the concerned department to repeat cleaning. Collect the rinse sample after cleaning. Read the absorbance and send the requisition to the department with remarks if satisfactory

ANNEXURE

Rinse sample intimation and report Format

REVISION HISTORY

Nil

ALSO READ: SOP for Testing Procedure of Water for Manufacturing Use