Auditing 

  • Good Manufacturing Practice as per EU Directive 2003/94

  • GXP including GDP and artwork studios
  • Active Pharmaceutical Ingredients (ICHQ7)
  • ISO9001
  • Inspection readiness/gap analysis audits 

Background & case studies

  • Conducted GMP, GDP, GXP and API audits in EU, USA, Japan, Taiwan, Bangladesh and India.  This is a key area of CommQP's services with some audits done through another auditing consultancy, Rephine (www.rephine.com).

  • To date (2016) CommQP have conducted over 50 API audits with typically four visits annually to various Indian pharmaceuctical companies.

  • Conducted GMP gap analysis audits for Indian pharmaceutical companies which resulted in successful regulatory inspections.

  • Successfully prepared for, and hosted MHRA audits (GMP & GDP) on numerous occasions for various clients.

  • Audited an American client to ATMP standard and they subsequently attained EU GMP approval. 

  • Planned and managed a client audit (top 10 pharma company) resulting in my client 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 Matthews 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 CommQP

Mukesh T Patel BSc(Hons) CChem MRSC CSci MCIPS
07831 398 653
mukesh.0001@yahoo.co.uk
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