First part qualification

First part qualification. First part qualification is a process performed the first time a new bonded assembly is manufactured or the first time a new tool is used to manufacture a bonded assembly. First part qualification provides assurance that all of the aspects that control bond assembly quality, such as the design dimensions, detail part manufacturing techniques, tool dimensions, layup procedures and autoclave cure cycle parameters are correct and will produce a bond assembly that meets the engineering requirements. 

The specific steps that make up a first part qualification depend on details of the bond assembly such as complexity and history of the part and complexity of the tooling. First part qualification of a simple flat sheet metal assembly is likely to be not much different than standard production, while qualification of a new and complex part is a lengthy and detailed process that often results in significant changes to details and tools. 

For a typical assembly, first part qualification begins with a rigorous dimensional check and painstaking prefit of all details on the bond tool. The assembly details are placed on the tool without adhesive, close contact between bond surfaces is verified and any detail or tool interference is corrected prior to proceeding. This is followed by fabrication of a verification film , or a simulated bond cure cycle of the assembly to allow measurement of the adhesive bondline thickness. 

The first part of the seal qualification tests is performed on a specific tightness test machine called BAGHERA at CEA Grenoble. It allows to study the relationship between the applied load, the seal... 

Qualification testing has two main parts The first part is associated with the individual systems, and the second part is for interfacing the individual systems to form the OCS. Testing of the individual components will follow the normal V model approach as shown in Figure 6.5. 

The remainder of this paper can be restricted to coals of North America, since this is the area for which we have data and in any case other contributors to this collection will deal with the coals of their own areas. The first statement above needs qualification we ourselves have no liquefaction data on Canadian coals, but Ignasiak et al. (48) present some in this collection.Relying, as in the earlier part of this paper, on geological information, we can say that the strata of the North Great Plains and Rocky Mountain provinces continue north into Canada, as does the Pacific province. Nova Scotia contains some Carboniferous coals related to those in the Eastern province. 

Electrodes and filler metal shall conform to the requirements of ASME BPV Code Section II, Part C. An electrode or filler metal not yet incorporated in Section II, Part C may be used with the owner s approval if a procedure qualification test is first successfully made. (See Nonmandatory Appendix A of ASME B31.12.)... 

Instrument qualification or validation refers to the process of demonstrating an instrument s suitability for its intended use. The first step is to write protocols to cover the four main qualification elements design qualification, installation qualification, operational qualification, and performance qualification. Another qualification element, re-qualification, can be written as a separate protocol or included as part of the PQ protocol. These protocols must be performed in sequence. If the protocol meets its acceptance criteria, then the next protocol in the sequence can be executed. 

The information in this chapter applies specifically to the first element sample preparation. The sample preparation steps are usually the most tedious and labor-intensive part of an analysis. By automating the sample preparation, a significant improvement in efficiency can be achieved. It is important to make sure that (1) suitable instrument qualification has been concluded successfully before initiation of automated sample preparation validation [2], (2) the operational reliability of the automated workstation is acceptable, (3) the analyte measurement procedure has been optimized (e.g., LC run conditions), and (4) appropriate training in use of the instrument has been provided to the operator(s). The equipment used to perform automated sample preparation can be purchased as off-the-shelf units that are precustomized, or it can be built by the laboratory in conjunction with a vendor (custom-designed system). Off-the-shelf workstations for fully automated dissolution testing, automated assay, and content uniformity testing are available from a variety of suppliers, such as Zymark (www.zymark.com) and Sotax (www.sotax.com). These workstations are very well represented in the pharmaceutical industry and are all based on the same functional requirements and basic principles. 

Remark 1 Note that the condition C3 is not required for finite convergence of the GOA/EP. This is because in exact penalty functions a constraint qualification does not form part of the first-order necessary conditions. However, note that C3 is needed to ensure that the solution (jc, y ) of the GOA/EP algorithm also solves (6.40). 

Operation qualification generally represents the first opportunity for plant operatives to use the computerized system in an operational condition and can be used as part of production personnel s training program on the system, plant equipment, and manufacturing process. 

The application of this process helps to ensure that, first, if the validation route is chosen, the appropriate resources are applied to the parts of the system that have the potential to affect product quality. Second, it provides the rationale to focus qualification effort on quality-related functionality while still ensuring compliance for the product(s). 

Method development of TLC has been thoroughly discussed in the recent books by Elke Hahn-Deinstrop, and Bernard Fried and Joseph Sherma.30,31 The most recent review article by Colin Poole and Neil Dias also provided certain guidance on method development in TLC.32 While the focus of this chapter is not on TLC method development, there are a few points that need to be stressed regarding method development from a regulatory perspective. First and foremost, use of qualified/calibrated equipment is part of the GMP compliance. In other words, all instruments must have updated Instrument Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) according to the company s SOP (Standard Operation... 

While validation has a relatively short technical history, in practice it has largely been directed at aseptic processing (autoclaves and media fill vials, etc.). In recent years validation has been progressively expanded, firstly to cover all manufacturing, then computer systems, analytical methodology and more recently into packaging processes. Coincident with this, validation has itself evolved into qualification, with defined parts ... 

Each product should be evaluated to determine whether it should be nugrated to the platform. This evaluation should also consider future products and designs. The evaluation has two key parts associated with it. First, a business case needs to be developed to detemune what are the specific expected benefits in terms of cost, interval, capacity improvements vs. the cost of implementation of the platform. Second, there needs to be an assessment to establish the technical feasibility of manufacturing the product using the platform. The technical feasibility must be done from both the design and process viewpoints. This will require that both process and design characterization have been completed. Once both benefits and technical feasibility have been demonstrated, specific experimental and qualification plans can be developed and implemented to nugrate products onto the platform. 

As an example for a subsequent level, the second level qualification criteria for criterion A 1 (suitability assurance) are given in table SI. Table S 2 gives the second level criteria of a part (namely the quality assurance part) of first level criterion A 2 (product assurance). The second part would be a table for V V, which has not been included, as only the principle of the qualification process is shown in this paper. For the same reason, also the further details of the first level criteria documentation, product safety, system safety, interface, compensation by operating experience, error reporting, and modification are not elaborated. Thus the GOTO. .. and other references in the description part of the tables, which are the pointers to the more detailed criteria are in most cases empty. 

The Letter of Support was established by the FDA and EMA in 2014 as a means to recognize the potential utility of exploratory biomarkers prior to qualification. C-Path s PSTC was the first biomarker submitter to receive a Letter of Support from the FDA and the EMA. The Letter of Support, as a regulatory outcome, resulted in part from the discussion between PSTC, EMA, and FDA and the realization that greater attention to promising biomarker programs would help facilitate the use of exploratory biomarkers. 

Since you know these requirements involve a driver s qualifications, the first place you ll begin your search is in Part 391 — Qualifications of Drivers. 

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