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TOP 5 GMP Downloads

1. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.

 

2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.

 

3. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.

 

4. Technical Agreement
and Delimination of Pharmaceutical Responsibilities.

 

5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance

 

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Experts

You need GMP information that is reviewed by GMP experts and is guaranteed reliable. Our advisory board includes members from US, Europe and Japan. They supervise the content and development of the GMP MANUAL. More than 50 experts around the world write articles that are peer-reviewed. You get the best GMP information when you need it.

Our panel has the right background and credentials to make sure that we provide the highest level of expertise and knowledge to the industry:

 

Author

1979–1983 MSc in Organic Chemistry / University Berne, Switzerland

1984–1986 PhD in Organic Chemistry / University Berne, Switzerland

1987–1988 Postdoctoral Studies / University of the Witwatersrand Johannesburg, South Africa

1989–1997 F. Hoffmann-La Roche, Basel, Switzerland, Production: Senior Production Manager with responsibility for the manufacture of a broad range of Active Pharmaceutical Ingredients and Vitamins, from gram to multi-ton scale. Implementation of GMP in drug substance manufacture and process improvements for existing products

1997 Biodoc, Haverhill, Suffolk, England, Production: Established GMP compliant documentation for this contract manufacturer

1997–2000 Raytheon Engineers & Constructors, New Malden, Surrey, England, Consulting: Dual role as Validation Manager and Business Development Manager. Engineering and GMP-consulting for clients in USA and Europe. Project management and personnel responsibilities

2000–2002 ABB EUTECH, Billingham, Cleveland, England, Consulting: Senior Lead Consultant for world-wide qualification and validation projects with emphasis on GMP and automation

2002–2007 GE Healthcare, Amersham, Buckinghamshire, England, Quality Assurance IT: Quality director for global IT. Responsible for the Quality Management System for pharmaceuticals and medical devices with regards to automated systems. Expert for internal and external audits and regulatory inspections

since 2007 PAREXEL Consulting, Uxbridge, Middlesex, England, Consulting: As Principal Consultant providing consulting services globally to the pharmaceutical and medical device industry. Task include all aspects of regulatory compliance, design and implementation of modern quality systems. Practice lead for Competitive Compliance and Quality by Design

1997/2004 Chartered Chemist and Member of the Royal Society for Chemistry (MRSC CChem) /Chartered Scientist (CSci)

since 2005 Member of the Parenteral Drug Association; President of the UK Chapter; Member of the PDA Regulatory Affairs and Quality Advisory Board (RAQAB)

since 2005 Author and Editor: “Quality by Design – Putting theory into practice”; “Risk Based Compliance Handbook”; “The Manager's Validation Handbook, Strategic Tools for Applying Six Sigma to Validation Compliance”, www.pda.org

since 1998 Presenter, Chairman and/or Member of the Organising Committee at over 60 congresses and conferences

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of chapter 16.G Quality by design (QbD))