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 |
Dear sir,
ReplyDeleteWe had a query regarding below case.
Kindly confirm,wether we can proceed as below or not? if not kindly guide.
Strip Packing /Blister packing: 1 or 2 or 3 Strips/Blisters are packed in a inner carton, where inner caton is a single sale unit. Innner cartons will be packed in Outer cartons and are packed in a Corrugated fiber box .
In such cases shall we consider as below.
Inner carton - Primary level packaging.
Outer carton-Secondary level Packaging.
Corrugated box-Tertiary level packaging.
Dear sir,
ReplyDeleteWe had a query regarding below case.
1) Strip/Blister Packing: 1 or 2 or 3 Strips/Blisters are packed in an inner carton, where inner caton is considered as a single sale unit in a respecive country.
Innner cartons will be packed in Outer cartons and then are packed in a Corrugated fiber box .
In such case ,shall we consider as below to implement the same.
Primary level of packaging: Inner carton
Seconday level of packaging: Outer carton
Tertiary level of packaging : Corrugated box.
Kindly confirm or Guide if any?
Thanks and regards,
J Bhaskara Rao,
Asst.manager,Pkg.Dev
Dr.Reddys laboratories Ltd,
Hyderabad.