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February 2012

Cindy Fazzi

FDA Says Part 11 Guidance Remains Status Quo

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

Time and again, rumors surface about the possible update of the 2003 guidance on the scope and application of 21 CFR Part 11. The never-ending speculation attests to the enduring interest in Part 11, not to mention the continued scrutiny of the regulation.

Asked to comment on the status of the 2003 guidance, Erica Jefferson, an FDA press officer, told GxP Lifeline: "There are currently no plans to update the guidance. We are still performing inspections per the 2003 guidance."

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Hedley Rees

The "Supply Chain" Patient is Sick: Is There a Cure for the Pharma Supply Chain? - Part 1

by Hedley Rees, Consultant, Biotech PharmaFlow

The pharmaceutical supply chain has never been in such turmoil and under such a global attack from both governments and regulators. The evidence is stark and mounting. Supply chain shortages in the US have moved even the president to demand urgent remediation. High level congressional committees have also asked searching questions of FDA and other involved stakeholders, in an attempt to discover what has been going on with high profile supply chain failures. Counterfeiting has become almost endemic, with detection and enforcement efforts stretched to the limit. Finally, and possibly the most worrisome factors of all, are the cases in which materials have been adulterated or substituted with toxic alternatives (for economic gain) and have progressed undetected through one or more stages in the supply chain causing eventual patient death.

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Patricia Santos-Serrao

The Odd Couple: Quality vs. Research (R&D)

by Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

Compliance is often seen as a subjective word, and at best can mean something very different from one functional area to another within the same organization. The compliance requirements for a quality group are very different from those in R&D groups such as clinical and regulatory affairs. Technology and processes can play a significant role in defining and meeting compliance requirements; however, if the technology is not flexible and configurable it can become difficult to implement one solution for all areas.

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Do you know who the 25 most influential people in biopharma are today? According to John D. Carroll, who writes for FierceBiotech, there are 25 big names that are "making waves" in the biopharma industry.
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