CommQP Consultancy Services:  Auditing & Training

  • Auditing
    • Good Manufacturing Practice
    • GXP including GDP and artwork studios
    • Active Pharmaceutical Ingredients (ICHQ7)
    • Advanced Therapy Medicinal Products (EU Reg. 1394/2007)
    • ISO9001:2000
    • Due Diligence
    • Preparation for regulatory and client audits
  • Training in GXP, Procurement and QA
Background & case studies
  • Conducted GMP, GDP, GXP and API audits in EU, USA, Japan and India.  This is a key ongoing component of my services some of which is done through another auditing consultancy, Rephine (www.rephine.com).
  • Successfully prepared for and hosted MHRA audits (GMP & GDP) on numerous occasions.
  • Audited an American client to ATMP standard and they subsequently attained EU GMP approval.
  • Planned and managed a client audit resulting in winning a £2.5m global contract.
  • Audited chemical and API plants in India in 1997 as part of a global sourcing project. 
  • Managed ISO 9000 internal audit programmes and currently do so for existing pharmaceutical clients.
  • Successfully hosted ISO 9000 audits on numerous occasions at various UK sites.
  • Provided GXP training on numerous occasions for various companies.  Most notable project involved managing and leading an off site pharmaceutical training and team building event for fifty personnel who ranged from company directors to operators.
Qualifications & experience
  • Qualified ISO 9000 lead auditor having previously completed ISO 9000 internal auditor training.
  • Previous roles involving auditing activities (GMP, ISO & commercial due diligence):
    • Chemicals Buyer at A H Marks
    • Commercial Buyer at Mars Inc.
    • Pharmaceutical Quality Manager at Mars Inc.
    • Pharmaceutical Compliance Manager at Matthews Brand Solutions (senior management appointment)
    • Group QA Manager at Matthews Brand Solutions (senior management appointment)
    • Consultant QP at Matthews & CommQP