Clarification on different packing for Bar code dt.7.9.2011

From: Uday Jadhav <uday.m.jadhav@gsk.com>

Date: Wed, Sep 7, 2011 at 5:35 PM

Subject: Clarification required on barcoding of export packs

To: "rd@pharmexcil.com" <rd@pharmexcil.com>

Cc: Abhijit Kulkarni <abhijit.s.kulkarni@gsk.com>, Siddharth Barve <siddharth.v.barve@gsk.com>

GSK Uday Jadhav Question:  As discussed with you today, kindly refer the attached file in which we have mentioned the various packaging configuration of our representative packs.  As per our understanding we have segregated the primary, secondary and tertiary level packaging which is being mentioned in the attached file. Request you to please confirm whether our understanding is correct and provide your comments & inputs on this so necessary modifications can be done accordingly.

GS1 GOPAL Answered: Your understanding is correct. I require clarity on S.No 6 ( Liquid packing1) where you mentioned bottle goes in one carton, as per my understanding you are  referring to monocarton , if that is so then it is absolutely right. 

GSK Uday Jadhav Question:  Also request you to confirm whether human readable codes are required along with the barcodes on the primary, secondary and tertiary level packaging because as  per the DFGT Notification (Public Notice No. 59 (RE-2010)/2009-2014 by Ministry of Commerce and Industry, GOI) dated 30th June, 2011 nowhere mentions the requirement of human readable code along with the barcode.

GS1 GOPAL Answered: Human readable information is required to be printed with the barcodes at all packaging levels and same has been mentioned in the user manual (uploaded on Pharmexcil website) which is made available as a guidance document to comply with DGFT Notification.

GSK Uday Jadhav Question: Further in the notification is being mentioned that the exporters of the pharmaceutical products will adopt a trace and track system and incorporate its features for exported medicines using barcode technolgogy as per GS1 global standards, however as per our understanding in trace and track system we should have association (a parent child relationship) between the primary, secondary, and tertiary level packaging hence please confirm whether our understanding is correct? if not request you to clarify the term trace and track system for the various level of packaging.

GS1 GOPAL answered: Exporters are required to maintain track and trace systems which would enable them to maintain traceability data related to the product that they export. And as you rightly mentioned that you would need to have parent child relationship which would facilitate you to identify/know which primary went into which secondary pack and which secondary pack went into which tertiary pack. Best Regards,

Sr.No.	Type of packing	Pack Style	Primary  level packaging	Secondary level packaging	Tertiary level packaing
1	Strip Packing	Strips are packed in a cartons, cartons are packed in a Corrugated fiber box	Strip	Carton	Corrugated fiber box
2	Blister Packing	Blisters are packed in a cartons, cartons are packed in a Corrugated fiber box	Blister	Carton	Corrugated fiber box
	Blister Packing	Blister is packed in a monocarton (one blister ina carton). Such monocartons are packed in a outer carton. And outer cartons are then packed in a corrugated fiber box	Monocarton	Outer carton	Corrugated fiber box
3	Ointment Packing	One tube is packed in one carton,10 such cartons are wrapped by a film to form a Bundle. Such Bundles of 10's carton are packed in Corrugated fiber box	carton	Film which forms a bundle of cartons	Corrugated fiber box
4	Tablet packing in bottle	Bottles are labeled, 10 such bottles are shrink wrapped by film, and shrink wrapped bottles are  packed in Corrugated fiber box	Label on the bottle	Shrink wrap	Corrugated fiber box
5	Liquid packing	Bottles are labeled, 10 such bottles are shrink wrapped by film, and shrink wrapped bottles are  packed in Corrugated fiber box	Label on the bottle	Shrink wrap	Corrugated fiber box
6	Liquid Packing 1.	Bottles are labeled, one bottle goes in one carton, cartons are packed in Corrugated fiber box	carton	carton	Corrugated fiber box
7	Injection Packing	5 Ampoules are packed in a single blister pack, such group of blisters are then packed in a carton, and cartons are packed in a Corrugated fiber box	Blister	Carton	Corrugated fiber box
As per the Drugs and Cosmetics Rules 1945 offered by RD
Sr.No.	Type of packing	Pack Style	Primary pack	Secondary pack	Tertiary pack
1	Strip Packing	Strips are packed in a cartons, cartons are packed in a Corrugated fiber box	Strip	Carton	Corrugated fiber box
2	Blister Packing	Blisters are packed in a cartons, cartons are packed in a Corrugated fiber box	Blister	Carton	Corrugated fiber box
	Blister Packing	Blister is packed in a monocarton (one blister ina carton). Such monocartons are packed in a outer carton. And outer cartons are then packed in a corrugated fiber box	Blister	Carton	Corrugated fiber box
3	Ointment Packing	One tube is packed in one carton,10 such cartons are wrapped by a film to form a Bundle. Such Bundles of 10's carton are packed in Corrugated fiber box	Tube	Carton	Corrugated fiber box
4	Tablet packing in bottle	Bottles are labeled, 10 such bottles are shrink wrapped by film, and shrink wrapped bottles are  packed in Corrugated fiber box	bottle	Shrink wrap	Corrugated fiber box
5	Liquid packing	Bottles are labeled, 10 such bottles are shrink wrapped by film, and shrink wrapped bottles are  packed in Corrugated fiber box	bottle	Shrink wrap	Corrugated fiber box
6	Liquid Packing 1.	Bottles are labeled, one bottle goes in one carton, cartons are packed in Corrugated fiber box	bottle	Carton	Corrugated fiber box
7	Injection Packing	5 Ampoules are packed in a single blister pack, such group of blisters are then packed in a carton, and cartons are packed in a Corrugated fiber box	amoule	blister	carton & corrugated fibe box