Volume 26, Number 3

Table of Contents

Articles

Primer of Design and Construction Delivery Methods for Today’s Modern Pharmaceutical and Biotech Facilities

by Brian Sirbovan, Dave DiProspero, Brian Larson
This article presents four common project delivery methods and discusses the significant features of each approach.

Achieving Faster Project Delivery – More Haste

by Gordon R. Lawrence
This article discusses how implementing proven Best Practices can help get products to market quickly and more competitively.

Capital Costs for Biopharmaceutical Process Retrofit Projects

by Stephen R. Higham
This article presents cost data and analysis from several recent large process retrofit projects inside an active manufacturing plant. It also provides cost data for several types of process equipment and digital fieldbus DCS systems. It compares retrofit costs with greenfield construction costs.

Efficient Qualification: A Holistic Approach to Effective Project Execution

by Anna K, Gordon Leichter
This article addresses an innovative development in project delivery that utilizes a risk-based integrated qualification approach based upon the effectiveness of off-site construction.

Interview with Ron Branning, Vice President, Commercial Quality, Genentech 

2006 Facility of the Year Winner: A Look at Baxter BioPharma Solutions Cutting-Edge Facility

by Rochelle Runas

Country Profile: Turkey - May/June 2006

Site Master Planning

by Richard Larkin
This article presents a methodology for the delivery of a Site Master Plan (SMP) for a pharmaceutical facility. It describes a three step execution and presents a list of issues that appear regularly during the development phase.

PCC Supplement

by Jerry Roth, Russ Somma, Sandra Greenberg, Alexander P. Demos
This article describes the credential development process utilized by the ISPE-PCC and the results obtained from the CPIP TM international practice analysis.

Departments

New Products and Literature

Industry and People

ISPE Update

Classified Advertising

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