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Taking up the theme introduced by Jill Wechsler in her July 29, 2015 “Regulatory Beat” column, the “carrots” for the pharmaceutical industry are the promise of a reduced frequency of regulatory inspections, whereas the “stick” if quality metrics are not reported is the possibility of having products designated as adulterate in terms of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA intends to request quality metrics from establishments registered with the agency under section 510 of the FD&C Act that are engaged in the manufacture of drug substances and drug products.

PDF file (240 KB) Searle, Ltd., 2002-12-27 "During the validation of the manufacturing process for Plaquenil, two of the validation lots had out of specification results for the hardness test.

However, in your validation report you concluded that lots xxxxx were in compliance because low hardness result tablets pass friability and high hardness result tablets pass dissolution testing.

The intention of this long-anticipated document is to establish a risk-based frequency of regulatory inspection for pharmaceutical companies through review of quality metrics data on lot rejection rates, frequency of invalidated out-of-specification (OOS) results, product complaints, and on-time rates for annual product and quality review reporting.

Quality metrics reporting would justify reduced general, pre-approval, and post-approval manufacturing change inspections and improve overall quality in the pharmaceutical industry.

What type of healthcare product providers would be exempt from the reporting requirements?

These would include Section 503B sterile compounders; regional blood banks; vaccine manufacturers and manufacturers of cell- and gene-therapy products; makers of allergenic extracts; and plasma-derived products.

It enables participants to gain the skills and knowledge necessary to meet current regulatory expectations.

Out of specification (OOS) results “are systematically invalidated in hundreds of cases without traceable and scientific based root-cause-analysis due to 'staff-errors,'" the statement says.

“Deviation- and OOS-management, but also protocol-, review- and reporting-systems are designed and executed in a way to systematically not document and report 'discrepancies, non-conformances, incidents, unusual events.'" The regulators also call for the site to not supply product to the EU until there is a successful re-inspection.

[2 I CFR 211.165(f) and 211.192].""Products with out of specification active ingredient assays are reworked. [21 CFR 211.15, 211.100 and 211.110].""There was no documented investigation as to why two.

Sets of samples were placed on stability and why both sets of samples fell out of specification before the expiration date [21 CFR 211.166]." PDF file (156 KB) Cumberland Swan, Inc., 2002-02-11 "The inspection revealed a failure to validate cleaning procedures, routine release of and failure to investigate out-of-specification test results for a mouthwash product." PDF file (394 KB) Bachem California, Inc., 2002-01-14 "Your firm failed to conduct investigation(s) of out of specification results obtained during the cleaning validation for lyophilization trays." PDF file (383 KB) American Pharmaceutical Partners, Inc., 2001-12-10 "Investigation Report records that Doxorubicin Hydrochloride Injection, USP, lot 01990 14B, was out of specification and lots 190879 were out of trend.




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If this property is True, Visual Basic fires the Validate event in the control that's about to lose the focus, thus giving the programmer a chance to validate its contents and, if necessary, cancel the focus shift. Imagine that you have five controls on a form: a required field (a Text Box control, txt Required, that can't contain an empty string), a numeric field, txt Numeric, that expects a value in the range 1 through 1000, and three push buttons: OK, Cancel, and Help.


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