The results of all the validation parameters were well within the
acceptance limit defined by the FDA guideline.
ACCEPTANCE LIMITS DEFINED BY INHERENT ANALYTICAL IMPRECISION
The thin dashed line represents the line of perfect agreement (y = x), the thick dashed line represents the Passing-Ba-block regression line (mean bias), the dark gray shaded area represents the
acceptance limits within the inherent imprecision of both analytical methods, the light gray shaded area represents the clinically allowable error limits.
These relevant residue limits can include
acceptance limits for cleaning of shared product contact parts, non-product contact surfaces, etc.
Precision parameter makes a case for attention to current specifications and
acceptance limits for the validation of alternative microbiological methods.
Representative chromatograms, spectra, calibration curves, method
acceptance limits, performance data and expected uncertainty of measurement results are all necessary.
* Designing the actual acceptance plan, including selecting quality characteristics, statistical quality measures, risks for buyers and sellers, lot sizes, numbers of samples (samples, sizes), specification and
acceptance limits, and payment-adjustment provisions
Cold testing provides no means of directly measuring engine horsepower or torque output, although power output can be assured by tight
acceptance limits in the cold testing process.
According to the Court, the only material limitations on Fortress's discretionary authority were net
acceptance limits, which provided maximum net liability exposures that Fortress could accept on behalf of each taxpayer on any one reinsurance contract.
The printer/recorder that is part of the delivery temperature recorder provides traceable documentary evidence of quality of the goods by giving the time and date as well as the actual temperature and
acceptance limits; sampling time intervals can be suitably programmed.
