Handling Packaging Designs (India)

| 11 minutes

India Vendors have different requirements for packaging designs, therefore the process of handling packaging is different.

India packaging is slower and more confusing, there are many details that need to be taken into account. It is even more important to make sure the mockups are correct the first time they are sent to Vendors, as it will take several weeks to get factory packaging and get it confirmed.

There are several requirements that Purchasing Person needs to follow.

India Packaging Requirements

1. Manufacturer License number must be on the all the inner packaging (box/blister/label), unless the order is produced on "neutral code" basis (no factory information on packaging). For "neutral code" basis Vendor has to provide the neutral code - a special code given to Vendors by India FDA. Neutral code has to be added to all elements of packaging (box, label/blister, insert).

Example of packaging with Vendor name:

Example of packaging with neutral code:

2. Generic product name (below the brand name) must be EXACTLY the same as in Product Permission (PP) that Indian manufacturers attain from the local FDA.
3. “BP/USP” must be on all the inner packaging (box/blister/label) in the generic product name and in the composition.

4. Storage conditions must be added to all elements of packaging (box, label/blister, insert) and have to match.

5. Composition has to follow specific format. Composition is clearly written in the PP and must be EXACTLY the same as in the PP (apart from spelling or formatting mistakes). For example:
Each 5ml of the reconstituted suspension contains:
Amoxicillin Trihydrate BP
(eq. to Amoxicillin)………………….200mg
Diluted Potassium Clavulanate BP
(eq. to Clavulanic Acid)…………….28.5mg
Excipients…………………………………q.s.
(in a flavored, thickened liquid base)

Composition must follow the above format according to the following points:

  • “Each 5ml” or “Each coated tablet” or “Each uncoated tablet”, etc.
  • “BP/USP” must be in the composition.
  • “Excipients…………..q.s” must be present (when applicable).
  • For liquid suspensions/syrup, “(in a flavored, thickened liquid base)”.
  • For coated tablets, this part should include the color of tablet (not only pink/yellow/etc., but the chemical element that gives color, for example “Titanium Dioxide”.
  • For capsules, “(Approved colors used in empty capsule shell)”.

Examples:



Before Starting India Packaging Process

Before starting the process, Purchasing Person needs to understand the following several points that will help to keep the packaging confirmation under control:

  • India Vendors work only with CDR files (not AI).
  • CDR FILES THAT ARE SENT TO VENDORS ARE LOCKED, which means the Vendor cannot make changes in the text, they can only REPLACE the text - which is not what we want due to format/font/spelling/punctuation etc. related reasons.
  • ALL THE CHANGES MUST BE APPLIED ON OUR SIDE due to the previous point. If mockups contain mistakes at the Factory Packaging stage, Salesperson does not need to inform the factory to make changes, changes have to be applied to CDR files and sent to Vendor again with corrections. Some situations can be an exception to this rule, which, however, have to be confirmed with Purchasing Manager.
  • If the fonts in Factory Packaging look different from Mockups, it is very likely that CDR files don't render correctly at Vendor’s side. In this case, Design Dept. needs to either change the CDR version to a lower one, or prepare a separate file with the fonts to send to Vendor.
  • If the process is followed correctly, Vendor will not need to change anything in the designs. The only thing Vendor needs to do is to save the CDR files as PDF/JPG and send them back. If Mockups have no mistakes and CDR renders correctly on both sides, the Vendor will send back perfect designs that can be confirmed quickly.
  • If Purchasing Person notices that Vendor is trying to recreate the CDR files, it means that there are many changes that need to be applied. It is easy to see that files were recreated, as they will look completely different from the Mockups (different colors, fonts, sizes, etc.). Salesperson has to control this process, and inform Purchasing Dept. to get all the changes required in one time, change the Mockups and send the Vendor revised CDR files. If no changes are required, the Vendor will not recreate the files.

India Packaging Checklist

To prepare correct Mockups, Purchasing Person needs to have the following information from the Vendor:

  • Sizes of all elements of packaging: box (carton), middle box, blister/label, insert, etc.
  • Mockups from previous orders of this Vendor (Salesperson will ask Purchasing Dept. to get mockups of any previous order that Vendor produced before for the same products). Salesperson needs to check the mockups to know the requirements of barcodes/QR codes, size for batch information box, any other requirements for empty space, etc.
  • Composition as per PP. If it takes a while to get PP draft, it is enough to make the Composition section according to Mockups received from Vendor as per the previous point.
  • Pictures of the finished product of previous orders to see the tablet color and shape, capsule color, bottle type, tray type, etc.
  • Manufacturer GMP copy to make sure the Vendor name, address and MFG license number will be the same on the designs. If Vendor name is not required on the packaging, then Salesperson needs to ask Purchasing Dept. to get the neutral code of the Vendor.
  • Vendor inserts from previous orders.
  • AdvaCare inserts mockups HAVE TO BE PREPARED in CDR according to the insert sizes from the Vendor. Purchasing Person needs to check whether inserts are in CDR format before sending them to the Vendor for the first time. The reason for this rule is that if it is not done, Vendor will have to put the insert text into CDR format themselves. As experience shows, it will mean a lot of mistakes, different formatting, spelling/punctuation mistakes, etc.
  • Salesperson needs to request Purchasing Dept. to get shipper dimensions and prepare CBM file in advance, and to be sure whether cartons will be printed or Vendor will apply stickers. If standard box sizes of the Vendor are changed, it will take longer to get the revised carton dimensions.

Salesperson will start working on the Mockups before all of the above information is received. The primary responsibility of the Salesperson is to control the process and not let it take months or go in endless circles. Salesperson can use the best judgement to determine which information is absolutely critical before creating mockups and sending them to Customer, and which information can be received later on. However, all of the above has to be clarified before Mockups are sent to the Vendor for the first time.

India Packaging Process

1. Salesperson confirms brand names with the Distributor and sends a task to Purchasing Dept. with required brand names and GENERIC PRODUCT NAMES as they have to be on the packaging. Generic Product Names must be consistent.
2. Salesperson sends a comment in the task to Purchasing person to request packaging sizes (box, blister, insert, carton), factory inserts, Vendor mockups from previous orders, and Product Permission (PP) draft from the Manufacturer according to brand names and GENERIC PRODUCT NAMES provided by Salesperson.
Note: Generic Product Names have to be the same as per USP/BP/EP etc. - whichever Pharmacopeia is followed by the Vendor producing the product. If Generic Product Name requested by the Salesperson is different from BP/USP/EP standard, then Purchasing person will send a task to change it according to the standard. BP/USP/EP has to be added in the product name on the packaging according to Product Permission. If Product Permission is not available, then Salesperson can refer to Vendor mockups from previous order.
3. Design person prepares the mockups using only CDR (cannot use AI) referring to India Packaging Requirements. Design person has to follow the sizes from the Vendor mockups (unless changes are applicable or unless the Vendor sizes are not received by this point), and write Vendor name, address, MFG license number as per GMP (or Vendor mockups).
Note: Salesperson needs to check JPG files created from CDR files (not AI or any other).
4. Mockups are checked according to the standard packaging process of Mockups confirmation.
5. If insert sizes are received by this point, insert design should be prepared in CDR and reflect the actual sizes of the future insert.
Note: Salesperson must check JPGs files of the inserts (not DOCX, PDF, etc.). JGP files are the only final and correct files as they are based on CDR files.
6. Salesperson sends designs (JPGs) to Customer to confirm, notifying that some elements such as size and other minor elements might change, but final designs will be provided in the PDCA. Distributor is to check carefully the content/text/images on the packaging, and provide translations (if applicable).
7. Purchasing person must receive all the information according to India Packaging Checklist section by this step. Design person checks the information, modifies the mockups if necessary and saves the JPG files from CDR (cannot use AI).
8. Salesperson checks the Mockups to make sure that all the information is correct according to India Packaging Checklist, writes comments in the excel file and sends a task to Design Dept. The process repeats until the design is final.
Note: Salesperson needs to check inserts ONLY in JPG format.
9. Purchasing person sends LOCKED Mockups to the Vendor in CDR format.
Note: Locked files means that Vendor cannot edit the existing text, but can change/add pictures and replace the text.
10. If Vendor returns the packaging with comments about changes that need to be applied, Salesperson has to evaluate each change, making sure it is absolutely necessary. If changes are necessary, Salesperson needs to send a message in task to Design Person to make the changes in the mockups. After all changes are made, Salesperson needs to check and ask Purchasing Dept. to send the mockups to the Vendor again.
Note: Salesperson needs to control the process and tell Purchasing Dept. to make sure that Vendor gives all the changes at once, to avoid back and forth and having to change the mockups multiple times. If Vendor is not giving all the corrections at one time, Salesperson needs to stop and ask Purchasing Dept. to tell Vendor that no changes will be done after this time, so Vendor needs to please double check if anything else will be required before mockups are sent again.
11. After changes are made and there are no more comments, Vendor returns the packaging in PDF/JPG format. Salesperson immediately checks, writes comments in the excel file and sends a task to Sales Manager to check. Sales Manager checks, writes comments in the excel file (if any).
12. If there are mistakes that originally came from AdvaCare mockups that were not caught before, Salesperson again needs to change the mockups and ask Purchasing Dept. to send the locked CDR files to the Vendor. To figure out where the mistakes came from, Salesperson needs to not only check JPG mockup files, but also locked CDR files, as sometimes the CDR versions render in a different way, or Design Person somehow made them different (didn't save the JPG file of the last locked version).
13. If there are mistakes that were made by the Vendor and are not present in original mockup files (not JPG and not locked CDR), it can only mean one of 3 things: either Vendor is recreating the designs instead of saving them in a different format (PDF/JPG), or there are differences in rendering of CDR files in different versions, or Vendor changed something in the CDR file (small changes). Salesperson needs to try to understand which reason it is.
13.1 If the reason of the above point is that Vendor is recreating the files, Salesperson needs to inform Purchasing Dept. or Purchasing Manager to talk to the Vendor and not allow them to do it in the future. In that case, the mockups need to be changed if necessary, and sent to the Vendor again.
13.2 If the reason is the rendering problem, Salesperson needs to talk to Design Person and see how to avoid this situation next time. Design Person can save the CDR files in a different version, or send font files or other files separately. After everything sent to the Vendor, Salesperson should receive correct Factory Packaging files.
13.3 If the reason is that Vendor applied a small change and it is not correct, Salesperson can either make some changes in Mockups and have Purchasing Dept. send the mockups again, or make a screenshot of the mistake and ask the Vendor to change it on their side. This is the only situation when Vendor should make any changes to the designs on their side.
14. Points 10-13 can be repeated until the Factory Packaging is correct. It is Salesperson's responsibility to understand why each round of revisions happens and avoid the repeat of the situation. While mistakes can happen in mockups, Salesperson cannot let packaging process take more than 1 extra round of Factory Packaging due to AdvaCare mistakes. Mockups have to be final and absolutely correct before they are sent to Vendors for the first time.
15. After Designs are printed and signed, Design person scans the files and sends a task to Purchasing person with the link to the confirmed PDF file.
16. Purchasing person sends confirmed PDF files to the Vendor to start the printing.
17. Salesperson sends the final PDCA to Customer to sign and stamp.
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