GLP Articles

As the use of digital computers escalated over the past forty years the financial costs of software failure increased correspondingly, and the importance of software testing grew.

Software development and validation are simultaneous processes. The processes of software testing start at the birth of the product and go on during the whole of its construction. Verification and validation are difficult because a developer cannot test the software forever and it is hard to estimate how much evidence is sufficient.

When applied to a computer system, validation, as defined by the FDA, can be interpreted as documented evidence, which provides a high degree of assurance that a computer system performs its intended functions accurately and reliably.1

This month's "MS — The Practical Art" will interest those starting a new good laboratory practices (GLP) bioanalytical laboratory, reassessing an existing laboratory, or revamping a "spirit-of-GLP" laboratory to full GLP status. Historically, mass spectrometers have been used largely in drug discovery owing to their qualitative capabilities and have escaped rigorous regulation. This is clearly no longer the case. Mass spectrometers are used increasingly as primary detectors in all facets of operations, which led to a column in 2004 exploring the changing nature of validation: "Taming the Regulatory Beast: Regulation Versus Functionalism" (1).

Many firms conducting internal accounting analyses find that performing GLP bioanalyses internally (as opposed to outsourcing them to contract laboratories) saves time and money. This economic efficiency is particularly true for large-sample-number studies because pricing tends to be based upon a per-sample method.

Good laboratory practice is the central dogma of all laboratory research and investigation - it's your commitment to regulators - and poor laboratory controls are a common cause of 483 observations and preapproval inspection failures.

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There are many ways to integrate building management and process control systems. One size does not fit all.

Multi-use, hybrid facilities are becoming the standard in the life sciences industry rather than the exception. Most facilities are designed to serve more than one purpose. While housing a manufacturing area may be a building's most important function, it may include a group of labs or warehousing space. These multi-purpose facilities create an interesting challenge. This article examines these challenges and potential solutions.

As an example, consider a facility with process and packaging lines, offices, a warehouse, some common spaces, and a cafeteria. The owner's challenge is to simultaneously manufacture the product, access and store the data, provide a comfortable environment, and comply with GxP regulations.