16 Questions
What does AQL stand for in the context of statistical sampling plans?
Acceptable Quality Level
Which risk is defined as the risk of error on the probability of rejecting a good batch?
Producer's risk
What is the purpose of validating manufacturing processes and assay methods?
To ensure consistency and accuracy
Why is homogeneity of the sample emphasized in the application of sampling plans to pharmaceutical dosage forms?
To ensure accurate and representative sampling
What is the grand average (X) value calculated from the given data?
10.59 mL
What is the Upper Control Limit (UCL) for the X Chart based on the factors provided in Table 2?
10.8
What is the sampling approach for homogeneous dosage forms like oral or parenteral solutions?
Taking samples of one unit only
What does it indicate when all points on a Control Chart fall within the control limits?
Control
How are semisolid dosage forms like ointments, creams, or suspensions typically considered for statistical purposes?
As similar to oral or parenteral solutions
Why is it advantageous to plot both X and R charts?
One chart may show control while the other may show excessive variation
What is the desirable level of sensitivity for inspecting packaging materials on high-speed packaging lines?
0.1% defects
What is the purpose of using Control Charts in pharmaceutical operations?
To aid in controlling and analyzing various parameters
What does 'Ri = Hv - Lv' represent in the context of process control?
The range between the highest and lowest values
In a control chart, what does 'UCLR = D4R' stand for?
Upper Control Limit for Range
What is the purpose of calculating UCLX and LCLX in process control?
To monitor the process mean over time
How do you calculate the Lower Control Limit for Range (LCLR) according to the given text?
LCLR = D3R
Test your knowledge on Statistical Process Control calculations based on the given data. Calculate the grand average, average range, upper control limit, and lower control limit using the formulas provided.
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