Pharmaceutical Artwork Origination

  • GXP auditing (gap analysis) for a pharmaceutical artwork studio and deployment of 'best practice' standard

  • GXP training appropriate for pharmaceutical artwork studios

  • Outsourcing artwork capability 

  • Sourcing and evaluating artwork systems providers

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

Background & case studies

  • Developed and deployed 'best practice' GXP guidance for a pharmaceutical artwork studio and ensured compliance against this.  

  • Provided GXP training for all relevant personnel engaged in pharmaceutical artwork generation.  This is an ongoing activity.

  • Established strategic partnerships with design houses, artwork studios and relevant consultancies e.g. PIL user testing so providing complete pharmaceutically compliant artwork solutions.

  • Conducted a GXP 'gap analysis' audit at US sister unit and instigated a pharmaceutical compliance programme.  Subsequently, hosted a pharma customer audit (top 20 company) at the US site which resulted in site approval for the supply of printed plates.

  • Conducted audits of major artwork providers on behalf of a global pharmaceutical company. 

  • QA member on project team responsible for implementing a web based artwork management system (12 month project).

  • Provided artwork and QA consultancy on a Kaizen project tasked at enhancing process efficiency and GMP compliance at all global sites (6 month project).

Experience & achievements

  • Only QP in Europe to specialise in pharmaceutical artwork origination.

  • Developed a GXP standard appropriate for pharmaceutical artwork origination companies which has been presented at various Packaging and Labelling forums and training courses around Europe e.g. ViB events, Visiongain, Informa, SMi, Management Forum, David Begg Associates and Pharmaceutical Quality Group.

  • Relevant roles:

    • Pharmaceutical Compliance Manager at Matthews Brand Solutions (senior management appointment)

    • Group QA Manager at Matthews Brand Solutions (senior management appointment)

    • Consultant Qualified Person at CommQP

  • Further details:
    Mukesh Patel profile on Royal Society of Chemistry website: http://www.rsc.org/AboutUs/News/RSCnews/Profile/2008/index.asp

Mukesh T Patel BSc(Hons) CChem MRSC CSci MCIPS
07831 398 653
mukesh.0001@yahoo.co.uk
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Company No. 8022888

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