[...]... within specification Consider what is termed the sample A sample is a small portion of a large bulk system that is acquired and taken into the analytical laboratory in lieu of the entire system For example, it is not practical to bring the entire contents of a 5000-gallon tank of liquid sugar solution used in a pharmaceutical preparation into the analytical laboratory for analysis The small portion of the. .. have a finite shelf life and cannot be confidently used as RMs after a certain period of time The concept of traceability is important to consider As mentioned above, traceability is a standardization chain in which one material is established as a standard via a second standard, which was established as a standard via a third standard, etc All secondary standards can be traced to a primary standard and... general laboratory operations include how to characterize an analytical standard, how to record observations and data, and how to label reagents and solutions Most laboratory operations even have an SOP for writing and updating SOPs Examples of specific laboratory operations include the preparation and analysis of a specific company’s product or raw material, the operation and calibration of specific instruments,... occurring in the solution preparation and instrument functions usually result in points that do not fit a straight line exactly However, a linear regression analysis can fit the best straight line to the plotted points, and a correlation coefficient, calculated from these data, indicates how well the absorbance values correlate with the concentration values The linear regression analysis and correlation... configured in order to make the measurement that is needed These can include sampling locations (from what parts of the whole bulk system does one take a sample), the actual taking of the sample (equipment and technique), the laboratory preparation of the sample, the instruments and equipment needed in the laboratory, and calibration and data handling methods Accuracy is the degree to which the result obtained... long, and thus the demand for quality is global For this reason, an international standards organization governing global quality has been created It is called the International Organization for Standardization or ISO, and is a worldwide federation of national standards bodies The purpose of the organization is to promote common standards developed by its technical committiees Each member body has a. ..upper management and instillation of a positive attitude toward quality on the part of each individual employee It then becomes a personal responsibility of each member of the team, including the laboratory personnel Figure 1.2 In a Total Quality Management system, all aspects of an enterprise, including managers, accountants, lab analysts, custodians, manufacturing personnel, researchers, production workers,... Repeating a routine analysis over and over again for a period of time (perhaps sometimes years) and assembling the results into a data set that is free of bias and determinate errors create a basis for calculating a standard deviation that approaches σ, the true standard deviation The ±2σ theoretically associated with 95.5% of the values (Section 4.3), or the ±3σ associated with 99.7% of the values then... primary standard became a standard by comparison to an RM, ultimately being compared to an SRM Part of this chain is formed by the analyst in his/her laboratory (the “end user”), while part of it may be formed between NIST and the vendors For example, a laboratory analyst can purchase a primary standard acid (which a vendor can certify as traceable to an SRM) for solution standardization and then base... base a number of secondary standardizations, such as acids and bases, on that one primary standard Similarly, an analyst can purchase an atomic absorption reference standard (which a vendor can again certify as being traceable to an SRM) and then make one or more dilutions of this reference standard before creating the final series for the standard curve ©2000 by CRC Press LLC For his/her part, the laboratory . pharmaceutical preparation into the analytical laboratory for analysis. The small portion of the solution, perhaps a small vial, that is obtained for the analysis is called the sample, and that is what. the demand for quality is global. For this reason, an international standards organization governing global quality has been created. It is called the International Organization for Standardization . utmost concern and care for quality — quality in design, quality in development, quality in production, quality in installation, and quality in servicing. Besides the laboratory, components may include