Anwarul Haque――奥星验证咨询服务部验证总监

Anwarul Haque――Austar Validation Consultancy Service Department Validation Director

Summary：

A cGMP and validation expert comes from the UK. More than 25 years of experience in the pharmaceutical industry holding senior positions in Production, Engineering and QA. He is currently employed at Austar, China, as the Validation Director. He has experience of managing Capital Projects, Integrated Commissioning and Qualification, Process Validation, Cleaning Validation, Computer Systems Validation (CSV), and Regulatory Compliance to EU-GMP and US-FDA cGMP, covering Aseptic Processing, OSD, API, Bio Pharmaceuticals, Veterinary and Radio Pharmaceutical. Be a regular reviewer of and contributor to International Society of Pharmaceutical Engineers (ISPE) - GAMP best practice publications. He has delivered presentations to industry forums including ISPE, the Parenteral Society in the EU and the US, and China as well as conducting training for Pharma companies.

Education：

Castleford Technical College, Castleford, Wakefield, England, Ordinary National Diploma in Electrical Engineering – Passed with Merit.

Leeds University, BSc (Hons) in Electrical and Electronic Engineering.

Institution of Mechanical Engineers, London, Post Graduate Diploma in Engineering Management

University of Bristol, Masters of Science in Engineering

Conducted US FDA cGMP (US-FDA 21 CFR210, CFR 211, and part 11) and EU-GMP (EU Directives) and WHO GMP training as well as validation training including GAMP and 21 CFR part 11 – electronic records; electronic signature.

Work Experience：

Labaid Pharmaceutical, Dhaka, Bangladesh, the Chief Technical Officer

Jacobs Centre of Excellence, UK, the Compliance and Validation Manager

Austar Group, China, the Validation Consultancy Service Department Validation Director

Project Experience:

Managed and controlled projects for Active Pharmaceutical Ingredients (API), primary and secondary manufacturing facilities (sterile liquid products, vaccines and oral solid dosages), biological, radiopharmaceuticals and veterinary medicines meeting the requirements of EU-GMP, US-cGMP regulations and GAMP guidelines.

Assisted pharmaceutical companies to obtain cGMP manufacturing license (EU and US) and presented regulatory compliance and validation documents to EU and US regulators.

Carried out cGMP Design Review, Impact Assessment and Risk Analysis, prepared Site Master Plan, implemented Quality Management System (QMS), prepared Validation Master Plan and Qualification Protocols (IQ/OQ/PQ), prepared Qualification Requirement Matrix, carried out Cleaning and Process Validation, Gap Analysis and rectification of deficiencies, led Integrated Commissioning and Validation Team of more than 30 engineers world wide.

Carried out strategic engineering, and manufacturing projects that met quality, cost and schedule. Specified, validated and advised on manufacturing equipment and systems selection. Qualified and prepared reports for utilities, HVAC, BMS, SCADA, DCS, LIMS, ERP/MRP, laboratory instruments and attended Factory Acceptance Tests and Site Acceptance Tests.

Organised, led and implemented prospective automation validation and legacy system validation, and concurrent validation of LIMS and IT Systems.

Carried out pre-regulatory inspections, routine self GMP audits, Third Party audits and supplier's audits all over the world.

Worked as a validation consultant to the some of the world's leading pharmaceutical and biological companies, such as Pfizer, GSK, Lilly, Aventis, Wyeth, Biogen, Genentech, etc.

Speak Experience：

“What to Do When You Fail an Inspection”, Computer System Validation 2002, Fourth Annual Conference for cGMP in Pharmaceuticals, 2002, London – ISPE, GAMP

“Validation of an Automated Aseptic Vial Filling Line”, The Parenteral Society seminar on ‘Validation of Computer Related Systems’, Beaconsfield, Bucks., UK – Parenteral Society of UK

“Clean room & aseptic filling” Parenteral Drug Industry Congress, Beijing, China, Sept. 2011

“Quality Management System from Industry Perspective” Industry Leadership Forum, ISPE-CCPIE China Conference 2011, Shanghai, China, Oct. 2011

Authored and Articles：

Technical Editor, The Pharma World Journal, Dhaka, Bangladesh, 2010

“Autoclave Validation” Phrama Bangladesh Exhibition, ABPI, Dhaka, Published in Feb 2010