January / February 2014 Cover


Application of Single-Use Equipment for Buffer Storage and Distribution in Medium Size mAb Production Facility
by Wilfried Kappel, Bhimasen Vadavi, Sanjay Lodha, and Daniel Karrer, PhD
This article presents a hybrid system approach in which stainless steel equipment and single-use equipment have been combined in the best possible manner for buffer preparation and buffer storage systems at a 2,000 L mammalian cell culture CMO production facility.

Evaluation of Controlled Manufacturing Environments following an Air Handling Unit Shutdown
by Catherine E. Anderson and Brian J. Lloyd, PhD
This article provides a methodology to evaluate the environmental impact of an air handling unit shutdown in a GMP manufacturing environment.

Electron Beam: An Emerging Practical Technology for Sterilization of Pharmaceutical Products in an Innovation-Driven Industry
by Jorge A. Sugranes and Anne F. Booth
This article presents an overview of the potential use of electron beam (e-beam) ionizing radiation as a versatile and innovative technology for sterilization in the pharmaceuticals manufacturing industry.

Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification
by Lorrie Vuolo-Schuessler, Mark E. Newton, Paul Smith, Christopher Burgess, and R.D. McDowall
This article presents a framework for harmonization of the approaches presented by the GAMP GPG on Compliant Laboratory Computerized Systems with the revised USP <1058>.

Cloud Computing in a GxP Environment: The Promise, the Reality and the Path to Clarity
by the GAMP Cloud Computing Special Interest Group (SIG)
This article presents the current issues facing adoption of cloud computing, paradigm shifted needed and a strategy for establishing guidance within the pharmaceutical industry.

The Blinding of Materials in Clinical Trials: Essential Processes for Ensuring the Integrity of Clinical Study Data
by Sandra Cook, Steven Yoder, Christina Owings, Barbara Campbell, and Charles GentileĀ 
This article explores concepts for maintaining the blind throughout a trial and at various nodes in the clinical trial material supply chain.

A Selected Comparison of 21 CFR Part 111 and USP General Chapter <2750> as Templates for Good Manufacturing Practices for Dietary Supplements
by Edward G. Malawer, PhD
This article presents a comparison of corresponding sections of 21 CFR Part 111 and USP <2750> using five dietary supplement GMP compliance issues each requiring some interpretation of the language provided by these documents.

ISPE Stretches its Reach in new Opportunities while Building on its Traditions
by Nancy Berg, ISPE President/CEO
Berg shares new opportunities to lead, build and enhance valuable Member benefits and increase the Society visibility among Members, companies and executives.

In This Issue