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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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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

Chemist

1977-1980 Study of Chemistry / University of Bristol, United Kingdom

1980-1983 Completion of Doctorate (University of Bristol, United Kingdom)

1983 - 1987 BP Chemicals, Hull, UK, Chemist

Explore the use of Organometallic species as catalysts in the synthesis of oxygenated carbon compounds using C1 feedstocks; optimisation of manufacturing plant; development of new processes.

1987 – 1992 Croda, Cowick Hall, UK, Chemical design and marketing

Design of performance chemicals at laboratory scale and demonstration of their effectiveness by performance testing; presentation of results to customers and use of feedback to re-design chemicals. Implementation of successful designs at plant scale.

1992 – 1993 Croda, Rawcliffe Bridge, UK, Chemical Development

Supervision of a team of R&D chemists covering new product and process development activities. Maintenance of quality critical computer master data.

1993 – 1999 Croda, Rawcliffe Bridge and Leek, UK, Quality Assurance

Maintenance of quality critical computer master data. Implementation of ISO 9002:1994, coordinating and driving continuous improvement activities (particularly involving IT applications and redesigning documentation systems), hosting customer audits. Enhancing the Quality management system to include links to SIO 14001 and GMP elements.

1999 – 2001 Croda, Rawcliffe Bridge, UK, IT Implementation.

Implementation of SAP R/3 Quality Management module for use by Croda globally. Transport of master data from legacy system to SAP. Although not a GMP project, the lifecycle was the same as the validation timeline.

2001 – 2004 Croda, Rawcliffe Bridge UK, Quality Assurance

Further design and implementation of quality management system. Registration of site to PQG PS 2100:2002 GMP for pharmaceutical excipients. Project leader for API plant installation, qualification and validation. Successful MHRA inspection (1st in company).

2004 – 2007 Croda, Leek UK, Quality Assurance

Enhancement of quality management system to meet ICH Q7 across the whole site (from ISO 9001). Project Management for design and implementation of an API onto site. Successful MHRA inspection.

2007 – 2010 Croda, Cowick Hall UK, Quality Assurance

Install and develop a department for product stewardship issues. Lead the UK, European sites in the development of QA and GMP in all aspects of operations and supply of our products.

Special Activities

Iain Moore is co-author of numerous publications on GMP for excipients and cosmetic ingredients.

From 2008 to 2009 he was Chair of the IPEC Europe GMP Committee. Since 2009 he is Chair of the IPEC Europe Excipient Certification Committee.

Publications at Maas & Peither GMP Publishing: