SOP for Preparation of Data Sheets for Working Standard

OBJECTIVE

To lay down a procedure for the Preparation and Control of Data sheets for working standards

SCOPE

This SOP shall be applicable for the preparation and control of the data sheets for all working standards of the Quality control department at XYZ Limited.

RESPONSIBILITY

Execution: Chemist – QC department.

Checking: Chemist and Above – QC department.

PROCEDURE

• Give the reference number to working standards as per the current version of the SOP.
• The front page, subsequent pages, and Certificate of Analysis of Datasheet shall be prepared following the approved format on A-4 size paper.
• Refer to Annexure-1, Datasheet for working standard (front page and subsequent pages).

ALSO READ: SOP for Preparation & Storage of Test Solution

• Refer to Annexure-2, Specimen format for Certificate of Analysis for working standard.
• Take a photocopy of Annexure-1 for use by an authorized person (Section In-charge).
• Maintain issuance record of datasheet as per Annexure-3 and List of Working standards.
• Prepare working standards as per the current version of SOP.

ABBREVIATION

SOP: Standard Operating Procedure

QC: Quality Control

No: Number

ANNEXURE

Annexure No. 1 -- Specimen format for Datasheet of working standard

Annexure No. 2 -- Specimen format for COA of working Standard

Annexure No. 3 -- Issuance Record for data sheet for working standard

REVISION CARD

Nil

ALSO READ: Qualification of Secondary Reference Standard