Regulatory compliance cost-effective

Precision of API peak area Precision of API retention time Asymmetry (USP tailing factor) of API Resolution between API and its isomer Signal-to-noise of precursor 

This chapter discusses regulatory issues in HPLC laboratories with a focus on procedures and requirements for system qualification, calibration, method validation, and system suitability testing. Examples in a cGMP pharmaceutical environment are used to illustrate the various tools and systems used to ensure the degree of HPLC data accuracy necessary to achieve the delicate balance of regulatory compliance and laboratory productivity. 

Miller and J.B. Crowther, Analytical Chemistry in a GMP Environment A Practical Guide, Jossey-Bass, New York, 2000. 

Good Laboratory Practice and Current Good Manufacturing Practice, for Analytical Laboratories, Agilent Technologies, Walbronn, Germany, 2002. 

Reuter, in S. Ahuja and M.W. Dong, eds., Handbook of Pharmaceutical Analysis by HPLC, Elsevier, Amsterdam, 2005, Chapter 12. 

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Development of non-risk remedial action objectives based on resource protection and other non-risk considerations. Resource protection objectives typically include numeric remedial action levels while other non-risk criteria are typically non-numeric and may include remediation timeframe, implementability, cost effectiveness, regulatory compliance, property use requirements, liability control, and community concern. 

Under the new administration, this section of TSCA has come under the scrutiny of Vice President Bush s task force on regulatory relief and the Office of Toxic Substances is placing a high priority on efforts to develop more cost-effective means for achieving industry compliance with OTS policies. In addition to fostering voluntary actions by industry wherever possible in lieu of formal rules, these effects include elimination of unnecessary burdens on industry in complying with mandated TSCA requirements. 

As discussed previously, industry is beginning to realize that there are profound benefits associated with pollution prevention, including cost effectiveness, reduced liability, enhanced public image, and regulatory compliance. Nevertheless, there are barriers or disincentives identified with pollution prevention. This section will briefly outline both barriers and incentives that may need to be confronted or considered during the evaluation of a pollution prevention program. 

Design reviews will ensure that the proposed system can meet the performance criteria in a reliable, consistent, and capable manner. In addition to establishing a robust design that can be qualified against predefined performance criteria, it is essential to establish an asset management strategy that will effectively and efficiently maintain the system performance, reduce maintenance costs, and improve regulatory compliance. 

The challenge is to conduct cost-effective, sufficient validation to ensure GxP compliance. As illustrated in Figure 5.2 [4], there is always debate over how much is sufficient to fulfill the regulator s expectations. Excessive validation may increase confidence in regulatory compliance, but it is expensive. 

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