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Biography

Ian Harwood has over 35 years experience of pharmaceutical manufacturing and GMP regulatory inspection.  He has experience of a wide range of pharmaceutical dosage forms ranging from non sterile manufacture of tablets, capsules creams and ointments through to large and small scale sterile manufacture, both terminal sterilisation and aseptic manufacture.

 

At the MHRA Ian has been the technical lead on unlicensed medicines and aseptic manufacture.  He has also gained significant experience of working with companies that have compliance issues  which have resulted in referrals to the Inspection action Group and Compliance Management Teams.

 

At MHRA Ian gained the following experience:

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  • Technical Lead for Unlicensed Medicines

  • Represented MHRA at various industry and NHS groups including NHS QA Committee, UK Radiopharmaceutical Group, BNSA.

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Conducted numerous inspections, overseas and in UK in the following areas:

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  • Sterile Manufacture

  • Non Sterile Manufacture

  • Unlicensed Medicines (Specials)

  • IMPs

  • Radiopharmaceuticals

  • Positron Emission Tomography (PET)

  • Biologicals

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Experience of inspecting with other regulatory agencies.

 

Work Experience

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From Feb 2022

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July 2014 to Feb 2022

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May 2013 to June 2014

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Nov 2009 to April 2013 

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Oct 2001 to Oct 2009 

 

April 1998 to Sep 2001

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Oct 1985 to  March 1999

 

 

Managing Director, Harwood Pharma GMP Consulting Ltd

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Senior GMP Inspector with Medicines and Healthcare products Regulatory Agency (MHRA)

 

QA Operations Manager - BTG Ltd

Helping to introduce GMP compliant systems to obtain MHRA and FDA approval for a unique combination drug / device drug delivery system.

 

 Senior QA Manager / Lead Qualified Person - Patheon Ltd

Releasing QP on the manufacturing and clinical trials licences.  The site produced both aseptically filled and terminally sterilized sterile  products. It also produced non-sterile products for commercial release and clinical trials.

 

Lead Qualified Person / Product Release Manager - Catalent Pharma Solutions. 

 

QA Manager - G&A Printers.

A pharmaceutical printing firm which was working to GMP standards.

 

Wyeth Manufacturing Ltd

Various roles in QA departments in a large multi product company.

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