Final method qualification

If a standard form was used in the qualification phase, a system should exist to rank the respondents that are being considered. Such a system can be as simple as the reviewers making a written recommendation summarizing the strong points of their selections. Some companies have developed forms that allow the final scores to be quantified. Appendix C, Sample Toller Assessment—Qjiantitative Format contains such an example. With either method, the client should consider having two or more reviewers discuss the candidates and agree on the recommended finalists. 

Finally, it needs to be noted that the final answers to questions concerning the processability and the qualification of a polymer reflect its behavior only in the individual circumstances of the commercial processing. The analytical methods described are only a tool for understanding special sectors of materials properties and how to solve problems in industrial polymer processing. 

Qualification or validation begins with a protocol or plan that describes fully the approach, including the scope, description of equipment, utilities, test methods, acceptance criteria, etc. The approved protocol is then executed by performing the requisite number of replicates as specified in the protocol and gathering the indicated data. The final step is the preparation and approval of a report containing the findings of the activity against the acceptance criteria found in the protocol. 

As noted, excipient manufacture should take place using qualified equipment and a validated process. Generally excipient equipment has been in place for many years so that classical methods of qualification, which is done as new equipment is commissioned, are inapplicable. To retrospectively qualify the installation, operation, and performance of equipment, it is suggested to rely on historical records. For installation and operation qualification, a protocol is prepared that illustrates how maintenance and production records will be used to support the hypothesis that the equipment was installed properly and is operating as intended. Then the protocol is executed by reviewing the maintenance and production records for the supporting data. Finally a report is prepared that includes the data from the records, which support the conclusion that the installation and operation of the equipment conforms to protocol requirements. It is suggested that maintenance and production records for a minimum of one year but preferably five years be reviewed. 

The big problem is that we use the term validation generically to cover the entire spectrum of CGMP concerns, most of which are essentially people, equipment, component, facility, methods, and procedural qualification. The specific term process validation should be reserved for the final stage(s) of the product/process development sequence. The essential or key steps or stages of a successfully completed product/process development program are presented in Table 2 [7],... 

In a well-designed validation program, most of the effort should be spent on facilities, equipment, components, methods, and process qualification. In such a program, the formalized, final three-batch validation sequence provides only the necessary process validation documentation required by the FDA to show product reproducibility and a manufacturing process in a state of control. Such a strategy is consistent with the FDA preapproval inspection program directive. ... 

The answer to the question, Does the method measure what we think it is measuring , must also be a qualified yes, the qualification being that most methods when newly introduced appear to measure either something more or something different from what we will finally discover they really measure. This often results from an excess of enthusiasm on the part of the early users, a fault which I understand well and to which I am particularly prone. Before starting any large-scale investigation, ideally we should spend a period of time on the methods to be used, so that we understand just what our choice of methods is actually able to tell us. Unfortunately, the real world seldom offers us this kind of preparation time the cruise date is always the day after tomorrow. 

Pre-qualification reduces a large set of initial suppliers to a smaller set of acceptable suppliers for further assessment. De Boer et al. (2001) have cited many different techniques for pre-qualification. Some of these techniques are categorical methods, data envelopment analysis (DEA), cluster analysis, case-based reasoning (CBR) systems, and multi-criteria decision making method (MCDM). Several authors have worked on pre-qualification of suppliers. Weber and Ellram (1992) and Weber et al. (2000) have developed DEA methods for pre-qualification. Hinkel et al. (1969) and Holt (1998) used cluster analysis for pre-qualification and finally Ng and Skitmore (1995) developed CBR systems for pre-qualification. Mendoza et al. (2008) developed a three phase multi-criteria method to solve a general supplier selection problem. The paper combines analytic hierarchy process (AHP) with goal programming for both pre-qualification and final order allocation. 

The following set of characterization methods suimnarizes the most commonly used test methods to qnahfy copper-clad laminates for manufacturing. It is intended to guide the materials engineer through the laminate qualification process. Yet it can only serve as a best-practices guide, as the final set of qualification methods will vary for each material and should always be driven by its specific application. 

In addition to the previously described test methods, many more can be found in IPC-4101 and in the test methods manual IPC-TM-650. All of these tests address laminate properties that may have a significant impact on the performance of the final product. The final decision as to which qualification tests to include or exclude always needs to be made on a case-by-case basis depending on the performance requirements for the printed circuit board. 

Within this chapter, first the requirements for bipolar plates are summarized, followed by a discourse on the appropriate qualification procedures to certify the quality of bipolar plates. For the two main technology chains, metallic and graphite-based bipolar plates, a summary on documented degradation mechanisms is given. Finally, a review on different approaches for materials and coatings used, production methods, and resulting stabffities of the realized bipolar plates is done. 

Starting with validated software and instrument qualification a validated analytical method is developed using the qualified system. Finally, total validation is achieved by defining system suitability. The analytical chemist is mostly concerned with steps (Hi) and (iv), but he might be (rightly) suspicious regarding developments beyond his field of vision. 

By introducing optimization method, the solution procedure of the reliability qualification test plan would be divided into two sections, one section is to solve the equations with continuous variable the second section is to obtain the final test plan by optimization process. Finally, an objective and steady plan can be obtained. 

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