Examples of expectations for HPLC. Example of expectations for dissolution apparatus. PQ testing and the appropriate preventive maintenance procedures and schedules should be prospectively defined and successful completion documented.
Roles and Responsibilities Several different groups are typically responsible for the qualification of an instrument. The user is responsible for assuring that the manufacturer's DQ is consistent with the user's requirements. Software Validation Software used for analytical work can be classified into three categories: firmware; instrument control, data acquisition, and processing software; and stand-alone software.
Computerized analytical instruments contain integrated chips with low-level software firmware. Firmware is therefore considered a component of the instrument itself. Operation of the instrument is then controlled via the software, leaving fewer mechanical operating controls. The manufac- turer should perform DQ, validate this software, and provide the users with a summary of validation.
At the user site, holistic qualification, which involves the entire instrument and software system, is more efficient than modular validation of the software alone. Thus, the user qualifies the instrument control, data acquisition, and processing software by qualifying the instrument according to the AIQ process. The validation process for this type of software is the responsibility of by the software developer, who also specifies the development model appropriate for the software.
Changes could occur as manufacturers add new features, improve current equipment or make changes to the instrument or its software, or as a result of instrument repair or maintenance. To imple- ment any change, an assessment of the impact of the change of instrument performance must be performed and the instrument must pass the appropriate qualification stages to assure its continued acceptable performance.
Conclusion It is critical to understand the importance of the analytical instrument quali- fication process and the steps it entails. A robust AIQ helps develop and maintain instruments that are reliable, perform as intended and are capable of generating analytical results that are consistent with user expectation. Author Biographies Dr. Horacio Pappa has been with USP since Horacio held the position of assistant professor of quality control in the Faculty of Pharmacy, Buenos Aires University, and Executive Secretary of the Argentine Pharmacopeia in the period — Good article , thanks and we want more!
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Also, I have shared your website in my social networks! This concept is similar to that of the comparison of the performance of two methods in the same group. An examination of statistical approaches for the former can be found in the references by Ellison et al while the latter is explained well in the USP reference PF 35 3. The type of statistics may be similar but the choice of materials may be very different when trying to show two methods are performing comparably rather than one method giving the same results with the same variability when tested in two different places.
For more detail regarding the specific applications of statistical methods please see the "References" subtitle at the end of this article. Lack of bias or comparison of means can be examined by a t-test if comparing two groups or by an ANOVA test if comparing more than two groups of data. For a confidence interval, 90 or 95 percent is often selected. The equivalence of two groups can be assessed through the application of TOST or two one-sided t-tests.
Visual assessments of data organized by various types of plots such as Bland-Altman is also helpful. For a good discussion on the equivalence of results by use of intraclass correlation coefficients or the concordance correlation coefficient, the USP 35[3] is a good reference. This article discusses the choice of statistics depending on the goal of the transfer.
This paper describes statistical approaches for determining equivalence through the use of confidence intervals for the equivalence of means. Confidence intervals will also help determine the limits of agreement method which defines the interval within which 95 percent of the individual differences should lie, the total deviation index and the tolerance interval which all help define if differences between laboratories are statistically significant.
Another good reference for statistical definitions and use in method evaluation is the classes guide entitled "The Fitness for Purpose of Analytical Methods. The classes guide entitled "Selection, Use and Interpretation of Proficiency Testing Schemes by Laboratories" is also a good reference for inter laboratory proficiency testing design, execution and evaluation. Pre-Transfer Assessment.
The work done prior to transfer is critical. This work ensures that the receiving lab is ready for transfer. Even if the transfer is group-to-group, lab-to-lab, or site-to-site, an audit function or gap analysis is beneficial to the process as an assessment of the current ability of the lab to accept the transfer and is also beneficial when determining what gaps such as equipment upgrades need to be done prior to transfer.
This includes a review of the laboratory environment,the equipment hardware and software , the temperature in some cases , humidity levels, and the placement of the equipment is a factor in determining the success of the transfer.
Finding out during the transfer that there is a mismatch in requirements-to capabilities will produce complications and potentially alter the path of the transfer. It can be beneficial to include upfront feasibility or practice runs of the protocol to make sure that the laboratory is ready, that the operators are trained, and that the procedure is well defined and understood.
Comprehensive Document Package. Even for methods that are in the development phase, a document package consisting of a draft procedure with extensive development notes included in the text is a helpful foundation for the transfer of knowledge.
With methods that are post-development, documentation is more readily available e. Doing the work up front to ensure laboratory operators are properly trained with a procedure that is well-written, well understood, and that contains acceptability criteria depending on the stage of the method is an area that is at times rushed which can cause significant delays in the process.
An assessment of the method performance against expected performance is another step toward building the proper foundation for transfer. Feasibility Runs. Feasibility runs can also serve as protection against spending time transferring a method that is not well understood or that is poorly performing. Identifying a technical lead at both the originating lab and the receiving lab is also important.
Certainly the availability of material should be discussed prior to the protocol approval with qualified and approved critical reagents, qualified HPLC columns, inventory of standards and a number of lots of available samples. This often results in a change in how the transfer will be executed, for example, if a critical reagent is difficult to purchase at the receiving laboratory, the transfer may also contain a section on the appropriate performance of additional critical reagent suppliers.
The number of lots available will, of course, affect the design of the comparative study and sometimes the type of statistical analysis that will be performed. A good reference on the aspects of sample planning and the effects on uncertainty, the effects of heterogeneity, analytical uncertainty, and measurement uncertainty is found in the classes guide entitled "Uncertainty from Sampling.
Project Planning. Some of the issues with transfer are exacerbated by a lack of planning and poor communication.
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