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Pharmaceutical Engineering Archives |
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Volume 15, Number 4 |
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| An Inside Look at How to Locate, Engineer and Construct an International Bulk Pharmaceutical Facility: The Intangibles are Key by Richard P. Anth & Leonard J. Burns  Download Article... |
Experiences on Audit Sharing by Annis Bratt, Michael J. Gladders & Alison West, PhD Sharing audits of vendors of computer based systems to pharmaceutical manufacturers in order to meet validation requirements more economically to all parties. Download Article... |
Pharmaceutical Engineering Interviews Ken Chapman by Ken Chapman An interview with the President of Drumbeat Dimensions, Inc. Download Article... |
Best Practice Engineering for Validation of Process Control Systems by Peter J. Coady & Anthony P. de Claire This methodology is shown to align with good project engineering practice and demonstrates how it is possible to design and implement a control system with the required quality attributes to support process validation, providing a documentation system which can be maintained and audited throughout the life of the system. Download Article... |
The Value of System Prototyping and Vendor Acceptance Testing by Wayne P. Davis, William J. Erhard & John C. McKenney This article presents a case study that focuses on the value and role of pre-installation testing in the validation of a control system. Download Article... |
The Integrated Validation Project Approach by Kenneth S. Dominy & Mark A. Fazio The integration of validation into the beginning of projects to insure consistency, quality and validatability while minimizing the costs associated with these requirements. Download Article... |
Investigational Materials Sample Retention Guide by Sue Galloway-Ludwig, Craig R. Garvey & Donald May This article summarizes the regulations, defines terms and provides a guide for compliance with regulations for retaining samples for investigational materials. Download Article... |
cGMP Human Drug Notes Human Drug Notes; A memo on Current Good Manufacturing Practice Issues on human use pharmaceuticals Download Article... |
Validation Tools and Techniques by M. Jerry Roth Review of some fundamental tools that can be used to minimize and resolve common validation problems. Download Article... |
Effective Project Management by Leonard Schwartz, PE The article explores the roles, skills, management style and thought processes of the effective project manager. Download Article... |
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