Monday, December 13, 2010

BATCH NUMBERING PROCEDURE

1.0              OBJECTIVE:

1.1               The objective of this SOP is:
2.1.1.        To describe a procedure for allocation of batch no. for products manufactured at____.

2.0              RESPONSIBILITY:

2.1               The Executive - Quality Assurance shall be:
2.1.2.        Responsible for giving batch Number.  
                   
2.2               The Chemist  shall be:
2.1.3.        Responsible for ensuring the following of Batch Numbering System.  

3.0              ACCOUNTABILITY:

Head – Quality Manager
                   
4.0              PROCEDURE:

4.1              BATCH NUMBERING SYSTEM FOR PRODUCTS FOR DOMESTIC MARKET:

Ø      For each product R & D gives a prefix, which is unique & product specific with respect to product name & strength, which is stated in master formula record.
Ø      While allocating Batch No. to a product, this prefix shall be used which shall be followed  by 5 alphanumeric characters.
Ø      The first character in the Batch No. is  a numeric figure, which stands for the year in which the batch is manufactured. For e.g. all the batches manufactured in the year 2005 have first character 5, for 2010 it shall be 10, like wise for subsequent years.
Ø      The next three characters are numeric values, which stands for the serial no. Of the batch for a particular product manufactured in the year.
Ø      For e.g. for first batch of a particular product it shall be 001, for second batch 002 and likewise for the further batches.
Ø      The next character in the Batch No. shall be “N”, which stands for the Kachigam..



Ø      The complete batch no shall be like CLTM-5001N
Whereas,
§         “CLTM” stands for the product batch or prefix, which may be either 3 or 4 alphabetic characters.
§         “5” stands for the year in which the batch is manufactured i.e. 2005
§         “001” stands for the 1st batch of particular product of the year.
§         “N” stands for product manufactured at Kachigam Daman.


4.2              BATCH NUMBERING SYSTEM FOR PRODUCTS FOR EXPORT

The product batch numbering system for export shall be differed from as defined in the stage 4.1 (Batch numbering system for products for domestic market) in respect that suffix “N” used for domestic market shall be replaced by ‘EN’ until the customer (contract giver) specifies the batch no.

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