Volume 26, Number 6
On-Line Exclusive Articles
Process Robustness – A PQRI White Paper
The Product Quality Research Institute (PQRI) is collaborative effort between the pharmaceutical industry, regulatory agencies, and academia. One of the purposes of PQRI is to promote discussion on current topics of interest in the pharmaceutical field. To that end, PQRI commissioned a working group to develop a White Paper that discusses the concept of process robustness and how it applies to development, scale up, and manufacture of pharmaceutical products.
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Avian Flu – Is My Company Prepared?
by Wendy Haines, Martin Rock
Who has not heard about avian flu? A threat of pandemic influenza came on the world’s radar screen with the emergence of the H5N1 influenza strain. In this article, we will talk about what we have learned from previous pandemics; how to mitigate fear and uncertainty; and some key parts of a strategic business management plan for pandemics.
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Pharmaceutical Regulatory Issues – Observations from Africa
by Deryck Smith Pr. Eng.
This article presents an overview of the differences between regulatory authorities between first world and third world countries, and the problems and solutions applicable to third world counties.
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Proposed New Joint Regulatory Authority for Australia and New Zealand
by Bob Tribe
This article presents the new joint Authority established to replace the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).
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Quality by Design, Validation, and PAT: Operational, Statistical, and Engineering Perspectives
by Ron Branning, Lynn Torbeck, Cliff Campbell
This article demonstrates how Quality by Design (QbD) concepts can be applied to process, data, and equipment systems and addresses the implications of FDA’s Process Analytical Technology (PAT) guidance.
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Regulatory Considerations and Business Implications for Automated System Suppliers
by Diarmuid P. Meagher, M. Saleem Hashmi, William G. Tuohey
This article reviews the relationships between quality and regulatory practices, and the implications for business performers for suppliers of automated systems to the pharmaceutical manufacturing industry.
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Set-Up and Validation of a Clean-In-Place (CIP) System for a Coating Pan
by Stefania Ucci, Alessandro Spadoni, Caterina Funaro, Guia Bertuzzi, Roberto Trebbi, Giovanni Ciaramella, Paolo Colombo, Ruggero Bettini
This article presents a study of cleaning performed to a clean coating pan in compliance with Health Canada’s updated guidelines on cleaning validation.
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Industry Interview Series: Gordon Munro, PhD, Senior Vice President, Quality Assurance, Watson Pharmaceuticals
Dr. Munro discusses the state of quality and compliance today, relating his experiences gained from high-level roles in industry and regulation. He shares his thoughts on major industry challenges ahead, including generics, biotechnology, the relationship between the regulator and the regulated, and harmonization.
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Practical Risk Management
by David Stokes
This article presents an overview of the comparative risks between the pharmaceutical industry and other industries, placing the hazards of pharmaceutical products in a context of overall public safety.
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Process Review for PAT – Selecting Cost Efficient PAT Projects
by Alex Brindle, Per Vase
This article presents a logical way to begin implementing PAT projects within an organization with an objective focus on return on investment based on process expertise, facts, and data.
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Current Good Validation Practice
by Brian Collins, Kieran Sides
This case study presents how a site validation policy was developed using a modular validation approach and incorporating the latest FDA initiatives, as well as principles from ISPE’s Commissioning and Qualification Baseline® Guide, GAMP® 4, and the GAMP Good Practice Guide: Validation of Laboratory Computerized Systems.
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Implementing Industry Focus Groups to Identify Skills and Knowledge Expectations for Recent College Graduates
by Jon Tomson, John E. Connors, Matthew A. Wells
This article describes a process that was developed and successfully used to directly solicit and capture the opinions and insight of individuals in the pharmaceutical industry in a format that could assist a university with development of a new graduate program.
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Industry and People
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New Products and Literature
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