Transformation in the Pharmaceutical Industry: Transformation-Induced Quality Risks—A Survey

Nader Shafiei; James L. Ford; Charles W. Morecroft; Paulo J. Lisboa; Mark J. Taylor; Yusra Mouzughi

doi:10.5731/pdajpst.2013.00917

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Transformation in the Pharmaceutical Industry: Transformation-Induced Quality Risks—A Survey

Nader Shafiei, James L. Ford, Charles W. Morecroft, Paulo J. Lisboa, Mark J. Taylor and Yusra Mouzughi

PDA Journal of Pharmaceutical Science and Technology May 2013, 67 (3) 229-246; DOI: https://doi.org/10.5731/pdajpst.2013.00917

Nader Shafiei

1School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK;

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James L. Ford

1School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK;

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Charles W. Morecroft

1School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK;

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Paulo J. Lisboa

2School of Computing and Mathematical Sciences, Liverpool John Moores University, Liverpool, UK; and

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Mark J. Taylor

2School of Computing and Mathematical Sciences, Liverpool John Moores University, Liverpool, UK; and

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Yusra Mouzughi

3Liverpool Business School, Liverpool John Moores University, Liverpool, UK

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vol. 67 no. 3 229-246

DOI

https://doi.org/10.5731/pdajpst.2013.00917

PubMed

23752750

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online June 10, 2013.

Author Information

Nader Shafiei1,*,
James L. Ford1,
Charles W. Morecroft1,
Paulo J. Lisboa2,
Mark J. Taylor2 and
Yusra Mouzughi3

¹School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK;
²School of Computing and Mathematical Sciences, Liverpool John Moores University, Liverpool, UK; and
³Liverpool Business School, Liverpool John Moores University, Liverpool, UK

↵* Corresponding Author: School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, L3 3AF, UK.

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PDA Journal of Pharmaceutical Science and Technology

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Transformation in the Pharmaceutical Industry: Transformation-Induced Quality Risks—A Survey

Nader Shafiei, James L. Ford, Charles W. Morecroft, Paulo J. Lisboa, Mark J. Taylor, Yusra Mouzughi

PDA Journal of Pharmaceutical Science and Technology May 2013, 67 (3) 229-246; DOI: 10.5731/pdajpst.2013.00917

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Transformation in the Pharmaceutical Industry: Transformation-Induced Quality Risks—A Survey

Nader Shafiei, James L. Ford, Charles W. Morecroft, Paulo J. Lisboa, Mark J. Taylor, Yusra Mouzughi

PDA Journal of Pharmaceutical Science and Technology May 2013, 67 (3) 229-246; DOI: 10.5731/pdajpst.2013.00917

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Keywords

Pharmaceutical transformation
Quality risks
GxP (good laboratory, clinical, and manufacturing practice) due diligence
Product transfer
biotechnology products
Expert opinion survey

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