December 2013

For Pharmaceutical Companies

Biosimilars Establishing Themselves in Europe

by Peter Calcott, Calcott Consulting LLC.

From the introduction of the Guidelines for Biosimilars in the EU in 2004, Europe has been pressing hard for the introduction of these money-saving options into the marketplace. The initial guidelines of 2004 were followed very rapidly with further guidances on comparability (2005), preclinical and clinical requirements (2005), recognition of the changing landscape (2010) and in 2011, further recommendations for studies and statement of the recognition of the issues surrounding licensure. To aid developers they even issued product specific guidances, recognizing that each molecule would have specific challenges to overcome. Why is the EU so far ahead of the U.S. in biosimilars and when will the FDA catch up?

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A Risk-Based Approach to Validation

by Peter Knauer, MasterControl Inc.

FDA classically has defined the requirements for validation under 21 CFR 820 and 210/211 regulations as a comprehensive testing process where all systems are given thorough examination and tested under equal weight, complete with an exhaustive evaluation process. This article describes a new definition of validation that has emerged. What is this new definition and how does it affect you?

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What if You Needed SOPs to Run Your Household?

by Laurie Meehan, Polaris Compliance Consultants, Inc.

Rosanne Sylvia-Heeter, Director of cGMP Compliance at Polaris, is always chanting the FDA compliance mantra, “If it’s not documented, it didn’t happen.” As I worked on the blog post with her last winter, I was struck by the amount of documentation actually needed to comply with 21 CFR Part 111 distribution regulations. Lately, I was struck by something else. In the course of simply maintaining a residence, members of my household actually perform a lot those Part 111 activities. And so do yours.

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An Argument for Quality Management Systems

by Kamaal Anas, Wright Medical Technology

All too often, quality management systems are seen as a cost of doing business – a requirement of regulators (e.g., 21 CFR 820), customers (e.g., ISO 9001:2008) or overbearing parent companies – rather than as a tool for management to effectively manage their organizations. However, quality management systems that are effectively designed, implemented, utilized and continuously improved upon provide management with quality information, delivered in a timely fashion, which facilitate data-driven decision making. Designing and implementing a quality management system that provides the appropriate information for management to make educated decisions requires careful thought and detailed planning. Once accomplished, management will have the tools to effectively allocate resources to risk-prone areas and reduce the cost of poor quality.

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