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Auditing

Services
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  • GMP & GDP audits cover:

    • Active Pharmaceutical Ingredients  

    • Finished dosage forms

    • Excipients

    • QC laboratories

    • Warehouses

    • Artwork studios
       

  • ISO9001
     

  • Inspection readiness & Remediation
     

  • Provision of GXP gap analysis audits in preparation for new MIA & WDA submissions or reassessments.

     

Background

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  • CommQP auditors collectively have conducted >250 audits around the world covering finished products, APIs, excipients & artwork studios.  Within this list, there are >80 API manufacturing sites in India. 
     

  • Two of the CommQP team are qualified ISO9000 Lead Auditors.
     

  • Some of the CommQP consultants are named as 'Head of Quality' on MIAs and as such host MHRA inspections.
     

  • Early in his career, Mukesh audited chemical and API plants in India in 1997 as part of a global sourcing project.  At Matthews, he was Head of QA and  responsible for managing ISO 9000 compliance at four UK sites.

     

Case studies
 

  • Client problem:
    For various clients, stemming back to 2006, there have been requirements to conduct GMP 'gap analysis' audits in preparation of an impending regulatory body inspection or first time inspection. 

    CommQP solution:
    CommQP have assisted these companies, through audits and training, enabling them to pass the inspections with minimal observations.   Mukesh's first MHRA inspections, for both GMP & GDP, were in 1999 at Mars Inc. where he was Head of Quality on the MIA.
     

  • Client problem:
    Early in 2020, at the start of Covid 19 pandemic, physical site audits ceased.  One of CommQPs clients, a leading audit consultancy, required alternative, effective audit options.

    CommQP solution:
    CommQP quickly devised a thorough desk top audit plan and report template suitable for API audits as well as a recommendation for re-audits in line with regulatory expectation.

  • Client problem:
    Early in 2020, at the start of Covid 19 pandemic, physical site audits ceased.  One of CommQPs clients, a leading audit consultancy, required alternative, effective audit options.

    CommQP solution:
    CommQP quickly devised a thorough desk top audit plan and report template suitable for API audits as well as a recommendation for re-audits in line with regulatory expectation.

  • Client problem:
    As part of a outsourcing programme in 2017, due to Brexit and requirement for additional capacity, the client company required suitable CMOs for the production of liquid medicinal products, tablets and capsules.  The prospective vendors were required to be GMP compliant and cost competitive.

    CommQP solution:
    CommQP audited several CMOs in Europe and provided a audit reports and executive report which included a risk summary of each CMO.  The client progressed activities based on the recommendations in the report.

  • Client problem:

An global pharmaceutical company was looking to outsource artwork capability.


CommQP solution:
CommQP audited eight artwork studios and provided a summary report which included recommendations of the most suitable options for their requirement.
 

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