qc

• Sampling is the process of removing the appropriate number of items from a population.
• Statistical Sampling is a method where a finite number of objects are selected from a population.
• Government Sampling Plan - master table, developed by engineers in 1942 - developed and adopted by the US department of defense - “military standards” - AQL: maximum % defective or the maximum number of defects per hundred units
• Random Sample is a sample in which each item has an equal probability of being represented.
• Representative Sample is a sample obtained according to a sampling procedure designed to ensure the parts of a batch are proportionately represented.
• Batch Numbering Systems are an example of how to assign numbers to batches.
• Inspection Methods include Single Sampling, where a decision is reached after one sampling, and Multiple Sampling, where the result is obtained after several samplings.
• Sampling Plan is a definitive working rule regarding size and frequency of sample, and is the basis of acceptance or rejection.
• Laws of Probability include Producer’s Risk (α), the probability of rejecting a good batch, and Consumer’s Risk (β), the probability of accepting a bad batch.
• Types of Sampling Plan include Square Root System, where the acceptance number (c) is specified by the AQL.
• Control charts are a type of graphical presentation of data over time that shows upper and lower limits of the process.
• The UCLR = D4 x R and LCLR = D3 x R formulas are used in Control Chart.
• The General Method of Statistical Control of Quality involves selecting a sample of size n at random, computing an average for each set of sample measurements, computing standard deviation, preparing a graphic control chart, plotting the average obtained from the sample average value, and taking corrective action if any plotted points fall outside of the established control limits, indicating that the process is out of control.
• An outlier is an observation that is numerically distant from the result of the data and deviates markedly from other members of the sample in which it occurs.
• Relative Standard Deviation (RSD) is the coefficient of variation, which is calculated by dividing the standard deviation by the mean and multiplying by 100.
• Control charts include Attribute Chart, Variable Chart, Mean Chart, Range Chart, P Chart, X Chart, R Chart, and others.
• The UCLx = X + A2R and LCLx = X – A2R formulas are used in Range Chart.
• Range is the difference between the largest and smallest results.
• Statistical Quality Control (SQC) involves monitoring quality through the application of statistical methods in all stages of production.
• Below zero is the most outstanding standard deviation.
• SQC consists of proper sampling and determining quality variation.
• In the handling of Raw Materials, they are examined visually for any damage and an adequate number of samples are taken.
• Accuracy in pharmaceutical analysis is the agreement of an experimental result with the true value.
• If the results of the Quality Control (QC) test are not satisfactory, the rejected materials are placed in the rejected materials area.
• If the results of the Quality Control (QC) test are satisfactory, the decision stickers are pasted on the quarantine stickers.
• Secondary Packaging refers to the packaging that does not come in contact with the product but is an accessory, such as labels, inserts, etc.
• Precision in pharmaceutical analysis is the measure of reproducibility of data within a series of results.
• Relative Average Deviation is the division of the average deviation by the mean, expressed in percentage.
• Standard Deviation is a measure of precision, which is how much variation or dispersion there is from the average/mean.
• Large Standard Deviation means data points are spread out over a large range of values.
• Reassay Dates are the date of retests and periodic testing is done to revalidate materials.
• Small Standard Deviation means data points tend to be very close to the mean.
• Average Deviation is the average of differences between the individual results and the mean, which is a measure of variability.
• Material Control in pharmaceutical analysis involves assigning a number to each batch of material received on the receiving tally report (RTR).
• To avoid mix-ups, different colored stickers are used for quarantine, approved, and rejected materials.
• Primary Packaging refers to the packaging that comes in contact with the product.
• Approved materials are brought to the approved materials area.
• Raw Materials are ingredients for use in manufacture.
• Raw Materials are quarantined until accepted or rejected by Quality Control (QC).