Identification & traceability of Batch SOP in Pharmaceuticals

In this post "Identification & traceability SOP in Pharmaceuticals" is describe how we can identify and trace a batch through batch no.

Identification & traceability SOP Purpose:

The purpose of this SOP is to design a System for assigning a unique number for Identification and Traceability.

Scope:

This SOP covers identification and traceability of all Raw Materials, Packaging Materials and Finished Products.

Responsibility:

1) Raw Material Store Supervisor is responsible to follow this SOP in assigning Identification Number to Raw Materials, received in store.

2) Packaging Material Store Supervisor is responsible to follow this SOP in assigning Identification Number to Packaging Materials, received in store.

3)    Production Manager is responsible not only to follow this SOP in assigning Identification Number to new Finished Product Batches but also to ensure that this SOP is followed in its entirety and reviewed timely.

Procedure:

All raw materials, packaging components are identified through a number derived from the receiving report number of each consignment which is prepared in the goods-in area upon receipt of the material.

Intermediates and finished goods are assigned with a unique batch no. by the production planning department.

The system provides identification and traceability to assign status and to carry out investigation of raw material used in the batch, in case of any problem.  The system also provides a mean to avoid inadvertent shipping of product to the customer.

Material Management, QA/QC and production department is to follow this policy and maintain the system.

A) RAW AND PACKAGING MATERIALS

Upon receipt all raw material and packaging materials are awarded with a number similar to that on receiving report generated by goods-in section at the time of receipt.

This R.R. No. is used throughout the production and can be traced out from the batch record when ever required.

B) INTERMEDIATE AND FINISHED PRODUCTS:

All intermediates and finished products are assigned with a six digit Alpha numeric batch number representing first two digits of the year of manufacture, followed by letter (A – M) representing month of manufacture(“I”  and “E” is not used in batch assigning)

Following letters are used for the month mentioned against them:

“A”    for      January

“B”     for     February

“C”     for     March

“D”     for     April

“F”      for     May

“G”     for      June

“H”      for     July

“J”       for      August

“K”      for      September

“L”       for     October

“M”      for     November

“N”       for     December   

Last three digits are numeric.

For example, if Batch number is:

                                         22A001

It represents 1st Batch of January of 2022. 

Batch no. of each strength of the product is assigned by materials control Dept.

with M.O. (Manufacturing Order) and P.T. (Packaging Ticket).           

Traceability:

The numbering system is capable to trace back each batch of product and lot number of each Raw Material and Packaging Components used to manufacture the products.

The record of all documents carrying this information is kept at Q.A./Q.C. Dept. as a batch record.