Requesting Packaging information for Registration

China: Packaging confirmation is the responsibility of Design Dept., so this SOP can be skipped.

India: Packaging confirmation is the responsibility of Purchasing Dept., so this SOP has to be read and followed carefully.

Similarly to Order process, Registration contains the step of packaging confirmation. Packaging has to be confirmed with the Vendor for any new registration during the registration process, as Artwork files have to be included in the dossier.

Packaging process for registration is no different from packaging process for the Order. Packaging process for orders is described in detail in the following SOP: Handling Packaging Designs (India).

Once registration deposit is paid, Purchasing Person must request the following information from the Vendor:

• Mockups from previous orders of the Vendor;
• PP draft (inform the Vendor to send the draft before submitting documents to FDA);
• Pictures of the finished product from previous orders of the Vendor to see tablet color, shape, capsule color, bottle type, etc.
• Vendor inserts from previous orders;
• Manufacturer GMP copy to make sure the Vendor name, address and MFG license number will be the same on the designs.

It is acceptable to request the above information from the Vendor before registration deposit is paid. Purchasing Person must follow up and make sure all the above information is received within several days after the request is sent, as registration cannot move forward without the above information (Salesperson cannot prepare artwork designs without this information).