Determination of Manufacturing Date for QC chemicals

  1. Objective

To lay down procedure for determining of manufacturing date for QC chemicals.

  • Scope

This SOP is applicable in quality control determining of manufacturing date for QC chemicals.                                            

  • Responsibility

QC Chemist / Officer                   : To follow the procedure and maintain as applicable.        

  • Accountability

Head Quality Control                  : For system Compliance

  • Procedure:  
    • Whenever manufacturing date is not mentioned on the label of Materials, We should decide the manufacturing date by following alternative methods:
      • With the help of Manufacturer’s enquiry by E-mail.
      • With the help of Batch coding system of Manufacture.
    • Batch Coding system of Manufacturer :

Different manufactures have their specific batch coding system from which manufacturing date can be decided few systems are given below:

  • Batch coding system for Merck:

Batch Number have Ten digits, in which first alphabet denotes the packing center, second alphabet denotes the month of manufacturing (A for Jan, b for Feb, C for March…… L for Dec.).  Third digit indicates the year of Manufacturing.

For examples: B.No.CA9C690024

Manufacturing Date: JAN 2019

  • Batch Coding System for S.D. Fine Chemicals:

Batch No. of material manufactured by S.D. Fine chemicals have 17 digits, in which first three digits denotes the manufacturing date. The First Alphabets denotes the month of manufacturing (A for Jan, B for Feb, C for Mar,………,L for Dec.) Second and Third digits represents the last two digits of year of manufacturing.

For Examples: B.No: A19A/0618/1312/31

Mfg Dt: JAN 2019.

  • Batch Coding System for Qualigens:

Batch No of materials manufactured by Qualigens have 10 digits in which five to eight digits decide manufacturing date. Suppose B.No is 2549/1 6802-1. For determining the Mfg date and Year, We should consider the digits i.e. 6802, last 2 digits 02 denotes the month of manufacturing i.e. Feb and to determine manufacturing year add 1940 in first two digits i.e. 1940+68=2008 year.

  • If batch coding system of manufacturing is not available send the e-mail with name of materials and batch No and ask for MFG.Date.

The E-mail addresses of manufacturers are given bellow:

LOBA CHEMIE:             info@lobachemie.com

RANKEM:                       rankem@avantormaterials.com

  • Annexure (S)

            -NA-

  • Reference (S)

            In-house

  • Glossary           

SOP                      :  Standard Operating Procedure

HOD                    :  Head of Department

QC                      :  Quality Control

  • Revision History
Rev. No. Details of changes Reason for change
 

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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