By Sandy Weinberg
This publication courses the reader via FDA legislation guidance and descriptions a complete technique for price relief in regulatory affairs and compliance. This publication explains six thoughts to cost-effectively conform to FDA laws whereas retaining product defense and bettering public entry via expense controls. It offers precious and functional advice via case reports from pharmaceutical, biotech, and scientific machine industries.
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A comprehensive analysis conducted independently and with real expertise is likely to result in a less expensive and more effective long-term solution. Thus the addition to the “internal QA/QC plus sporadic FDA oversight investigations” model of an independent expert auditor whose report will provide management with a comprehensive corrective strategy and will provide the FDA with a clear and credible audit report. It is a valuable cost-containing compliance strategy. Implementing that strategy carries real advantages when the auditor brings expert credentials to the table.
The potential to end up feeling like a fool is high; the pressure not to is intense. Imagine, too, the relief you feel when the visited company is well-organized and presents for your review a series of clearly documented, internally reviewed, signed, and dated (prior to testing) specific standards. Each SOP is tied to the appropriate legal regulation; each interpretation has an explanation that is footnoted to an expert opinion, regulatory guideline, or other credible source. And the internal SOPs demonstrate a clear understanding of, and respect for, the principles of patient and product safety.
Of course, should the FDA require (or even strongly encourage) a QbD approach to manufacturing, the cost-containment issue will quickly become moot. If QbD is state of the art for the industry and an expected and necessitated approach, the issue becomes one of minimizing the cost of QbD implementation rather than a comparison between the expense of having or not having a QbD system. 6 PROCESS UNDERSTANDING 39 in any design proposal or request for proposal for any new or replacement manufacturing system component.
Cost-contained regulatory compliance by Sandy Weinberg