Procedure for batch numbering system

1.0	PURPOSE To describe the procedure for product batch numbering system.
2.0	SCOPE This procedure specifies the proper way for allotting batch numbering system of products manufactured at Psychotropics India Limited, Haridwar.
3.0	RESPONSIBILITY         For Operation..........IT Incharge         For Supervision........ QA Chemist /Head production
4.0	ACCOUNTABILITY Head QA
5.0	PROCEDURE
5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13 5.14	A distinctive combination of unique numbers/Letters which specifically identifies the product, a batch, & all relative documents of product considered as batch number.                                                                                                                               Batch No. issued for any product in tablet section contains two alphabet with four digits e.g. AA-0001.            Where AA- Indicates tablet in financial year 2012-2013.            0001. – Indicates serial number of the product. 5.1           Second tablet batch no. will be AA-0002 and so on. 5.2             5.3           Batch no. issued for any product in ointment section contains two alphabets with four digits, e.g. BB- 0001.            Where BB – Indicates for ointment/lotion manufactured in financial year 2012-2013.            0001. – Indicates serial number of product. 5.4           Second batch in ointment section will be BB-0002 and so on. 5.5             5.6           Batch no. issued for any product in soap section contains two alphabets with four digits, e.g. CC-0001.            Where C – Indicates for soap manufactured in financial year 2012-2013.            0001. – Indicates serial number of product. 5.7           Second batch in soap section will be CC-0002 and so on. 5.8             Batch no. issued for any product in liquid oral section contains two alphabets with Three digits, e.g. DD- 001.            Where DD – Indicates for liquid oral manufactured in financial year 2012-2013.            001. – Indicates serial number of product.            Second batch in liquid oral section will be DD-002 and so on. Batch No. issued for Food product in both tablet/Liquid section contains two alphabet with four digits e.g. FF-0001.Where FF- Indicates Food product in financial year 2012-2013.            0001. – Indicates serial number of the product. 5.9           Second tablet batch no. will be FF-0002 and so on. For next financial year 2013-2014 product code for tablet will be EE and batch no. issue will be for example, EE-0001,EE-0002, EE-0003 so on. For next financial year 2013-2014 product code for ointments will be FF and batch no. issue will be FF-0001,   FF-0002, and FF-0003. For next financial year 2013-2014 product code for soap section will be GG, and batch no. issue will be         GG-0001, GG-0002 and so on. For next financial year 2013-2014 product code for liquid oral will be HH and batch no. issue will be HH-001, HH-002, and so on. Batch No. issued for Food product in both tablet/Liquid section contains two alphabet with four digits e.g. FG-0001.Where FG- Indicates Food product in financial year 2013-2014.            0001. – Indicates serial number of the product. 5.10       Second tablet batch no. will be FG-0002 and so on. As per third party requirement Batch No should be changed according to party requirement and issue batch no as per their norm provided by him. This product batch no. issue system is verified by QA, QC and Production Department with co-ordination              of Marketing and Finance Department. Batch No. issues will be recorded in batch No. issue register per format given.
6.0	REFERENCES      Nil

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
NIL

8.0	ABBREVIATIONS

Abbreviations						Full Forms
SOP						Standard Operating Procedure
QA						Quality Assurance
QC						Quality control
IT						Information Technology
9.0	DISTRIBUTION
Master Copy							Head Quality Assurance Department
Controlled office Copy No. 1							Head Quality Assurance Deptt.
Controlled office Copy No. 2							Head Quality Control Deptt.
Controlled office Copy No. 3							Head Production (Tablet) Deptt.
Controlled office Copy No. 4							Head Production (Liquid) Deptt
Controlled office Copy No. 5							Head Production (External) Deptt
Controlled office Copy No. 6							Head Production (Soap) Deptt
Controlled office Copy No. 7							Head I.T. Dept.
10.0		REVISION HISTORY
S.No.			Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)