Showing items tagged as Validation

  • How Do I Follow The Trail?

    1 May, 2014 by Jamie Colgin, President, Colgin Consulting, Inc.

    One of the most effective audits I ever participated in started with a systems-naive auditor asking a simple question: "Imagine I'm a sample arriving at your loading dock. What happens to me?" We proceeded down the trail together, following the sample through the processes of accessioning, analysis, reporting, and storage.

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  • A Risk-Based Approach to Validation

    10 December, 2013 Peter Knauer, Partner Consultant, 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. Recent guidance and initiatives by FDA (Process Validation: General Principles and Practices) and ICH (Q11: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES) have provided a streamlined risk based approach under an updated life cycle management methodology. Under this scenario, a new definition of validation has emerged, best described by FDA as “the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process is capable of consistently delivering quality products.” This is in contrast to the classical definition as perhaps best emphasized in the device regulations under 21 CFR 820.75:

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  • Disaster Recovery and Validation

    12 June, 2013 Louis Rutledge, Manager of Services Development / Validation ServicesMasterControl Inc.

    Disaster! Today’s business world shudders at the word. With the current random occurrences of hurricanes, super storms, earthquakes, blizzards, fires, flooding and sustained power outages, it is a wonder how companies can recover to survive all of the natural or modern threats to their daily business operations and collection of business data. Today’s business world is dependent on the data created and stored for many aspects of daily operations: financial data; product specifications; designs;

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  • The EMA 2012 Guidance for Process Validation

    19 February, 2013 Peter H. Calcott, Ph.D., President, Calcott Consulting LLC

    In February 2012, the Committee for Proprietary Medicinal Products (CPMP) issued the latest version of the new EU Guidance for Process Validation (PV). At the end of October, the opportunity for consultation (comments period) closed, marking the time when the various committees review the comments for inclusion or modification of the document. Sometime in 2013, the formalized document will be issued for use. However, generally, what is presented at this stage is often close to the final versio

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  • Process Verification vs. Process Validation: What You Need to Know

    10 May, 2012 Andrew Snow, Momentum Solutions, LLC and Walt Murray, MasterControl, Inc.

    Note: The views expressed in this article are those of the authors and do not necessarily represent those of their respective employers, GxP Lifeline, its editor or MasterControl, Inc.

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