Volume 33, Number 3
Supply Chain Management
Establishing and Managing a Vendor Network for Clinical Supply Manufacturing Services
by Francis Dumont and Sandra Onorato
This article presents some essential operational and evaluation aspects of the Request for Information/Request for Proposal (RFI/RFP) process when conducted for the purpose of establishing a vendor network for clinical supply manufacturing services.
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Pharmaceutical Engineering Interviews
Roger Nosal, Vice President, Global Chemistry, Manufacturing and Controls (GCMC), Pfizer
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Facilities and Equipment
An “Eco-Friendly” Assessment of Cleaning Agents in GMP Regulated Facilities
by Elizabeth Rivera
This article discusses cleaning agents used in GMP applications and relevant issues in minimizing pollution, reducing waste, managing personnel hazards, and complying with local regulations.
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Facility of the Future: Next Generation Manufacturing Forum Part III: Identifying Facility Requirements Based on Specific Business Drivers and Uncertainties Using the Enabling Technologies
by Mark Witcher, PhD, Jeff Odum, CPIP, and Michael Zivitz
This article is the third of a three-part series focused on defining the facility of the future required for manufacturing biopharmaceuticals in the 21st Century.
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Effective Computerized System Compliance through Leveraging Supplier Effort
by Members of the ISPE GAMP® Leveraging Supplier Effort Special Interest Group
This article describes a controls framework that can be used to assess risks and determine a validation strategy that leverages supplier effort appropriately.
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Commissioning and Qualification (Verification) in the Pharmaceutical Product Process Lifecycle
by David Dolgin
This article discusses the role of Commissioning and Qualification as “Stage 2a” of the Process Validation Lifecycle described in the US FDA’s Guidance on Process Validation. It also explains how the concepts of Quality Risk Management and QbD are incorporated into facility and system verification efforts as detailed by two recently published ISPE Guides.
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A Comparison of Process Validation Standards
by Jeff Boatman
This article presents a comparison between the Global Harmonization Task Force (GHTF) validation standard and the US Food and Drug Administration’s (FDA’s) process validation guidance.
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Global Regulatory News
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ISPE Members Making an Impact on Industry Issues Worldwide
ISPE President and CEO Nancy Berg discusses the impact that ISPE’s new direction is making on individual Members, the companies they work for and regulatory and industry relationships around the world.
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- Second ISPE-FDA Event Attracts Top Names, Features Release of Drug Shortage Survey Results
- ISPE Releases New Guidance for Standardizing Use of Booklet Labels in Global Clinical Trials
- ISPE Releases New Guidance for Definition and Use of NIMPs in Clinical Trials
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Classified Advertising with Advertiser’s Index
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