July/August 2013
Volume 33, Number 4

NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2013 ISPE. All rights reserved.)


 

Information Systems

Compliant Cloud Computing – Managing the Risks
by David Stokes
This article presents pharmaceutical business process owners with an explanation of what cloud computing is, how it differs from traditional Information Technology (IT) outsourcing, and how the specific risks associated with cloud computing’s essential characteristics can be understood, assessed, and mitigated.
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Has MES Reached Maturity in the Pharmaceutical Industry?
by Desmond Savage
This article presents the findings of a study that demonstrates MES is being adopted by the pharmaceutical industry.
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A Leaner Software System Development Process
by James E. H. Stafford, PhD
This article presents new insights into software design, including a more efficient way to implement software without undermining regulatory expectations.
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Research and Development

An Introduction to the ISPE IP COP Survey on Patient Experience Related to Investigational Medicinal Products
by Christine Milligan, PhD, MBA, Esther Sadler-Williams, MSc, MRPharm S, and Karen Gram, MSc (Pharm)
This article presents a summary of a survey on patient experience related to Investigational Medicinal Products (IMPs) conducted by the ISPE IP COP.
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Regulatory Compliance

Good Manufacturing Practices for Halal Pharmaceuticals
by Kenny Peng, MASc, RAC, PEng and Roziah Hanim Abdul Karim, BS
This article presents an overview and analysis of a new national standard on halal pharmaceutical products, MS 2424:2012, published by Malaysia, a member of PIC/S.
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Regulations and Guidelines of Computer Systems in Drug Manufacturing – 25 Years Later
by Orlando López
This article presents a regulatory review of the current requirements applicable to computer systems in the manufacturing environment..
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Global Regulatory News

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Facilities and Equipment

Innovative Mixing Technology
by Gabriela Mikhaiel
This article discusses fundamental challenges in powder mixing and an innovative mixing technology aimed to improve blending processes.
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Also Inside

From The Editor

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ISPE Update
Quality by Design in the Biopharmaceutical Industry; The GAMP® Community Celebrates 21 Years; A Special Thank You to ISPE Guidance Document Team Members
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New Product Highlights and Classified Advertising with Advertiser’s Index

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President's Message

Members Are the Strength of ISPE
by Nancy Berg
ISPE President and CEO Nancy Berg discusses the importance of active participation in the Society and how it leads to the development of pivotal events, initiatives, and publications that are shaping the industry and strengthening regulatory relationships.
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Online Exclusives

The Culture of Quality
by Randolph Fillmore
This article summarizes discussions on quality that took place throughout the ISPE Second Annual Conference on Redefining the "C" in CGMP.
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Quality Risk Management to Deliver Therapeutic Benefit: A Holistic Approach
by Jaspreet Gill
This article presents a summary of a presentation on a holistic approach to Quality Risk Management by Jaspreet Gill, Vice President of Global Quality and Compliance at Baxter.
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GAMP 21 Years Later
by David Selby
In this special Online Exclusive GAMP 21st Anniversary commemorative article, founding chair David Selby and other GAMPers give a personal view of the history, the present, and the future of the GAMP COP.
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NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2013 ISPE. All rights reserved.)