Regulatory Open Forum

 View Only

  • 1.  Packaging artwork mock-ups

    Posted 14-Oct-2011 03:21

    As regulatory professionals (in pharma or devices) many of you will no doubt be involved in preparing, reviewing and signing-off packaging artwork mock-ups. A mock-up is defined as a copy of the flat artwork design in full colour, presented so that  following cutting and folding where necessary, it provides a 3D replica of the packaging (with text) e.g. a carton.

    I am interested to know if any of you still experience or or more of the following of have any other issues to share concerning packaging artwork:
    • Still use paper mock-ups for final sign-off of packaging artwork
    • Electronically mark up mock-up pdfs with corrections and return them via emails to the author
    • Mark up printed paper copies of artwork mock-ups with corrections, then scan/email/fax them to the author 
    • Regularly send/receive mock-up pdfs via email, sometimes resulting in confusion about which is the correct final approved version of a particular packaging component e.g a leaflet, carton etc.
    • Save pdfs of packaging mock-ups on your local or networked pc/laptop hard drive so that occasionally when you foget to save a pdf, there is confusion about the currently approved version of a packaging component
    • Encounter problems with language related issses for products sold worldwide

    I'd be happy to help anyone seeking a solution to any of the above. Please contact me directly via email.

    Thank you

    -------------------------------------------
    Nilesh Sheth
    Regulatory Consultant
    United Kingdom
    -------------------------------------------


  • 2.  RE:Packaging artwork mock-ups

    Posted 14-Oct-2011 13:29
    We use Adobe Acrobat 8 Professional version to electronically route both drafts and the final approval via a server link in an email message.
    Drafts are maintained on a dedicated enterprise server with appropriate folder structures for ease in searching. As each draft is commented on ( e-post-it notes and other annotation tools in Adobe) the comments are "published" into that file on the server so that all reviewers can see them.
    Once everyone is happy with the art ( 2-D with die cuts outlined), a Final version is sent with pre-established signature boxes for the required sign-off responsible functions. The software has been validated and is 21 CFR Part 11 compliant ( Electronic Records and Signatures regulation from US FDA). The signature is managed via Microsoft Certification Services - there is a process to issue a validated signature certificate that is stored on a secure server and linked to the signer's account.

    Lastly, the final file is posted onto an .ftp site that the contract printers can access via internet to download the approved art and print the job.

    -------------------------------------------
    Carroll Hoyle
    Global Regulatory Affairs
    BSN Medical
    Rutherford College NC
    United States
    -------------------------------------------






    Original Message