Acceptable lower specification limit

The points where L(x) intersects the acceptable lower specification limit 8 can be obtained by finding the roots of the following equation 8 - L(x) = 0. It should be pointed out that this equation can also be written in the form... 

Since the minimum of all the expiration dating periods is the shortest shelf life among all batches, this estimate will provide a 95% confidence that the strength of the drug product will remain above the acceptable lower specification limit. 

An acceptable approach for quantitative characteristics that are expected to decrease with time is to determine the time at which the 95% one-sided confidence limit for the mean degradation curve intersects the acceptable lower specification limit. If analysis shows that the batch to batch variability is small, it is advantageous to combine the data into one overall estimate and this can be done by first applying appropriate statistical tests (for example, p values for level of significance of rejection of more than 0.25) to the slopes of the regression lines and zero time intercepts for the individual batches. If it is inappropriate to combine data from several batches, the overall re-test period may depend on the minimum time a batch may be expected to remain within acceptable and justified limits. 

An acceptable approach for analyzing an attribute that is expected to decrease with time is to determine the time at which the 95% one-sided lower confidence limit, also known as the 95% lower confidence bound, for the estimated curve intersects the acceptable lower specification limit. Where the estimated curve is assumed to be linear based on 24 months of real-time data and the lower specification limit is assumed to be 90% of label claim, an expiration dating period of 24 months could be granted. When analyzing an attribute that is expected to increase with time, the 95% one-sided upper confidence limit for the mean is recommended. 

Ermer and coworkers [15, 38], recommended that the acceptance criteria for the standard deviation of the determinations should be lower than 1/6 of the specification range (upper specification limit, USL minus lower specification limit, LSL), or calculated using the following equation ... 

Values for acceptance criteria, RSD, upper and lower specification limits, including significant figures... 

Based on this, the Kiosk Configurators determined that the kiosk should display the refinancing terms within two minutes (120 seconds) for all users. In essence, the team set an upper specification limit (USL) at 120 seconds. There is no lower specification limit (LSL) because an instantaneous response is still acceptable (although very unlikely). 

The IVIVC allows one to shift the dissolution criteria from the in vitro side to the in vivo side. The plasma concentration-time profiles that correspond to the lots that are on the upper and lower limits of the dissolution specihcations are predicted. Acceptable dissolution specification limits are limits that do not result in more than 20% difference in AUC and Cmax (usually 10% of the target/bio formulation) (13). 

To calculate the Capability Index for a process, information about the process must be known including an acceptable average, upper and lower specification limits, and the knowledge that the process is in statistical control. An acceptable value for Zj and Zyis 3.00 or greater. Referring to a Z table, a Z value of 3.00 indicates that approximately. 1% of the readings will be above the upper limit while a Zj value of 3.00 indicates that approximately. 1% of the readings will be below the lower limit. 

These results must be shared (ASAP) with Tom in the warehouse. Together we conclude that careful venting of the drums and then-prompt use would be safe. The raw material is perfectly acceptable— and has probably received more thorough analysis than any lots received in quite some time Furthermore, an investigation, with the supplier of the ethoxylate, is undertaken to learn whether sodium borohydride has been used in our shipments in the past or if this was a one-time mistake. If it was not a mistake, can it be eliminated In addition, the recommendation was made to change our raw material specification by reducing the amount of allowable moisture and raising the lower pH limit. Finally, a full report on this incident was written for the company files. 

Compared with conventional impurities measurements, trace analyses caimot be expected to achieve the same linearity and precision values. This is due to the lower signal-to-noise ratios inevitable at low levels. Hence, while the same approaches can be used, greater latitude will be necessary in the acceptance criteria. What must be demonstrated is that the data is statistically valid to show that the levels of toxic analytes are below their specification limits. 

It is now clear that electrochemical measurements can often have significant advantages over the classical spectroscopic approaches. Amperometry can be more specific therefore, lower detection limits are often feasible. Because electrochemical detectors do not require optical carriers, they can be much less expensive than UV absorption or fluorescence detectors. This is especially true when one considers that electrochemical detectors are inherently tunable without the need for such things as monochrometers or filters. On the other hand, there can be significant problems with reliability, and, more often than not, there is a lack of acceptance by chemists weaned on Beer s law. Amperometric methods in biochemistry are just beginning to be commercialized, and it is now almost certain that they will come into widespread use. 

Establishing specification limits from the test data derived for a given parameter. Based on the data collected and using statistical techniques, determine the extremes of acceptable hardness (high and low) that would provide 95% assurance that the friability, disintegration, and dissolution specifications would be met (upper and lower control/ release limits). 

Determination of the ABE of two drug products (T vs. R) is based on the comparison of the means of logarithmically transformed PK parameters, such as AUC and Cmax- BE is accepted if the difference of the log means (jUt and jUr, for the T and the R formulations, respectively) falls between specific predefined values for the upper and lower BE limits... 

If the secondary function determines that placement of the current operator would violate the maximum hardware specifications, one of two actions will take place. If the user has chosen to run in "hard mode, the maxlist values are accepted as hard limits that cannot be violated by the scheduler, so a negative value is returned by the priority function so that placement is delayed. If, however, the user has chosen "soft mode," wherein the initial maxlist values imply a lower limit on hardware and CSTEP may choose higher limits according to utilization, the tertiary priority function is invoked. 

Calibration checks, which have been common in the field, are now included in the statement. A calibration check is a quantitative check to make certain a specific concentration of a test gas is reaching the sensor. In a calibration check, a known traceable concentration of a test gas is used to make certain the sensors and alarms respond to the gas within the manufacturer s acceptable limits — typically 10-20% of the test gas concentration, unless otherwise specified by the manufacturer. In a calibration check, there is no adjustment of the sensor. The statement clarifies that bump tests are qualitative checks that make certain gases can get to the sensor and that the alarms for the lower explosive limit are working. 

The other type of regulatory measure is that which sets tolerance limits, especially on food and water. Although there are few specific limits for potable water supplies, the generally accepted target of 1 pg/1 for chlorinated pesticides is rarely exceeded by any of the chloro-aromatics, and concentrations are generally much lower. 

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