Artwork Origination

Management Forum 2009

1/11

Services
 

  • Deployment of GXP artwork origination standard as developed by CommQP
     

  • Auditing pharmaceutical artwork studios 
     

  • GXP training appropriate for pharmaceutical artwork studios
     

  • Outsourcing artwork capability 
     

  • Sourcing and evaluation artwork systems providers
     

  • Pharmaceutical packaging design and patient information leaflet user testing
    (in collaboration with a CommQP partner company)

Background  

  • Mukesh is the only QP in Europe to specialise in pharmaceutical artwork origination.

  • CommQP had developed and deployed 'best practice' GXP guidance for a pharmaceutical artwork studio in 2006.    

  • CommQP trained Royal Society of Chemistry QP Assessors in GXP for a pharmaceutical artwork origination (2008).
     

  • CommQP have presented their pharmaceutical artwork origination GXP standard at various Packaging and Labelling forums and seminars in Europe.  Also training has been provided at client sites namely in UK and USA.

Case studies
 

  • Client problem:
    A major USA based pharmaceuticals client contacted CommQP in 2012 to aid sourcing and assessing artwork origination studios for EU and Asia-Pac markets.

    CommQP solution:
    CommQP assessed the client recommended suppliers with inclusion of other options.  As a part of this project, eight artwork studios were audited for GXP compliance and suitability to meet client requirements.  Based on this work, the client selected a one supplier whom CommQP later were requested to train.  The project was successfully completed in time and on budget.

  • Client problem:
    The company's US sister unit was to be audited by a customer to potential supply of printed plates.  The site was not would not meet the required standard in it's current state.

    CommQP solution:
    CommQP conducted a GXP 'gap analysis' audit at US site and instigated a quality and pharmaceutical compliance improvement programme.  The site subsequently, passed the inspection (a pharma top 20 company) and were approved as a vendor for the supply of printed plates.
     

  • Client problem:
    A major pharmaceutical company were on boarding a new artwork management system, initially for UK then rollout to USA sites.  The company lacked QA oversight, specifically related to GXP compliance of artwork origination systems. They required Artwork Origination-QA expertise for this 12 month project in 2011.  

    CommQP solution:
    CommQP acted as QA Consultant on project team responsible for implementing the web based artwork management system. The system was successfully adopted meeting the company goals.