The Column - June 2009 - 4

The Column www.thecolumn.eu.com Vosloo to all instruments that fall into Group C, such as HPLC and LC–MS systems. But for Group A equipment, qualification is now essentially achieved by visual inspection of the instrument. Conformance of Group B instruments is determined according to the standard operating procedures for the equipment, and documented during IQ and OQ. Through this classification system, USP simplifies the qualification of basic laboratory equipment. However, when a piece of equipment that would normally be classified in Group A becomes part of a complex system, it can require a more thorough qualification than just visual inspection. As such, the classification system of USP is open to interpretation. Do It Yourself? With USP appearing to simplify the qualification of basic equipment, some laboratories adopt a ‘do-it-yourself’ approach. Relying on internal resources can lead to incorrect classification of equipment within USP and the potential compliance risk of inadequate qualification documentation. Incorrect classification often arises when simple laboratory apparatus forms part of a more complex system and therefore its classification within USP changes. It remains good qualification rationale to always consider the context in which the equipment will be used. Temperature Mapping In order to qualify temperature-controlled storage equipment, conditions need to be monitored across a number of internal positions — a process known as temperature mapping (see Figure 1). To assess the performance of the storage environment, information must be reliably gathered over a designated period of time, using an approved validation method. The requirements for temperature probe calibration and measurement traceability are given in ISO/IEC 17025, where traceability is defined as the ability to relate a measurement result to the appropriate International Temperature Scale of 1990 (ITS-90). Ensuring that temperature probes are calibrated to internationally recognized standards, such as COFRAC or UKAS, guarantees the generation of accurate and consistent results throughout the qualification process. Understanding the importance of a robust qualification approach for its temperaturecontrolled storage equipment, UCB decided to outsource its compliance support. Individual protocols were tailored to meet specific laboratory requirements and custom ‘open door’ tests were also developed along with additional alarm and system verifications checks. These ‘open door’ tests allow the equilibration profile to be monitored, establishing the time taken for normal temperatures to be restored (see Figure 2). With technological advances in this area, it is now possible to use wireless probes that enable seal integrity to be maintained during testing. Streamlining the qualification process by using a single validation master plan has allowed UCB to harmonize its documentation across multiple vendors and technologies. With all documentation in one place, it is easy to review and prepare for an audit. By using a software-based temperature mapping solution, full traceability is guaranteed and the possibility of human transcription error has been removed. Administration and equipment downtime has also been reduced through 4 1 9 Contents Tips & Tricks 2 13 Vosloo Rainville and Mather 6 17 News Meeting Review 8 20 Market Trends & Analysis Events & Contacts

The Column - June 2009

Table of Contents for the Digital Edition of The Column - June 2009

The Column - June 2009
Laboratory Equipment Qualification: Back to Basics
News
Market Trends and Analysis
Tips & Tricks: GPC/SEC
Confirming Peak Identification in Bioanalytical Studies Using Dual-Scanning MS Technology to Achieve ProductIon Confirmation
Meeting Review
Events
The Column - June 2009 - The Column - June 2009
The Column - June 2009 - Laboratory Equipment Qualification: Back to Basics
The Column - June 2009 - 3
The Column - June 2009 - 4
The Column - June 2009 - 5
The Column - June 2009 - News
The Column - June 2009 - 7
The Column - June 2009 - Market Trends and Analysis
The Column - June 2009 - Tips & Tricks: GPC/SEC
The Column - June 2009 - 10
The Column - June 2009 - 11
The Column - June 2009 - 12
The Column - June 2009 - Confirming Peak Identification in Bioanalytical Studies Using Dual-Scanning MS Technology to Achieve ProductIon Confirmation
The Column - June 2009 - 14
The Column - June 2009 - 15
The Column - June 2009 - 16
The Column - June 2009 - Meeting Review
The Column - June 2009 - 18
The Column - June 2009 - 19
The Column - June 2009 - Events
The Column - June 2009 - 21
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