Cost-contained regulatory compliance by Sandy Weinberg

By Sandy Weinberg

This booklet courses the reader via FDA law guidance and descriptions a accomplished technique for rate aid in regulatory affairs and compliance. This publication explains six innovations to cost-effectively conform to FDA laws whereas conserving product security and enhancing public entry via rate controls. It presents beneficial and useful suggestions via case reports from pharmaceutical, biotech, and clinical machine industries.

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Example text

An independent, experienced, expert auditor should append his or her resume to the final audit report. That resume will be carefully reviewed by the FDA field investigator to determine the credibility of the report. Of course, if the auditor is known to the investigator either through prior contact or reputation, the credibility of the report is enhanced and is de facto established. Finally, the audit procedure must be established with a clear Standard Operating Procedure approved in advance of the audit.

In the penicillin fermentation chamber, for example, sensors can increase or decrease temperature, adjust the pressure, and turn on or off the agitator without awaiting the action of a quality control person. The result is much more rapid, more certain, and less subject to human error. The final PAT characteristic is not fundamental to the concept, but may represent a secondary benefit. Because PAT in effect automates a part of the quality control process, the use of PAT permits remote monitoring of a laboratory or manufacturing system.

The cost of compliance has been contained through the judicial use of clear, operational definitions of real regulatory requirements, and the risk is mitigated and is not dependent on the inflationary effect of building higher and stronger walls in an attempt to understand the whims and future preferences of a higher power. ” It is the agency’s task to oversee and assure the regulation, but primary responsibility for the oversight of quality rests with the industry itself. It is as a direct result of this important distinction that a company without an implemented quality oversight plan is out of compliance, even if the actual formulation and manufacturing procedures meet established standards.

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