Qualification analyzer

If the technical staff from the client company recognizes that a toller may be asked to perform new analyses and make operating decisions based upon the results, the client may help the toller develop the needed procedures and skills required to make these decisions. Typically a round robin laboratory qualification exercise will be performed. Samples of known standards and unknown concentrations of the materials to be analyzed for the toll will be prepared and sent to both laboratories. This can help ensure that equipment calibration is synchronized and that the toller is capable of performing accurate measurements. In some cases, the toller may be the party with the chemical, process, or synthesis specific expertise. 

The qualification being that it must fail safe not only in its normal mode of operation, but, also, under specific modes of failure. Therefore, it is not enough to state that the circuit is of low voltage, and because of this is intrinsically safe. This is only half of the requirement. To qualify as intrinsically safe, the circuit must also fail in such a way as to be incapable of causing ignition, and further, it must be either tested or analyzed according to prescribe methods. 

For the purposes of instrument qualification, the PQ involves testing the equipment for overall system functionality. For dissolution equipment, these tests verify that the equipment can perform the entire dissolution process. A sample method should be observed to run properly. This can include running actual chemistry and analyzing the data results. 

System qualification is a process that ensures that an analyzer system is installed and operated according to requirements that are aligned with the intended use of the system. The commonly used approach in the pharmaceutical industry is the system life cycle or SLC process. In the SLC approach, the definition of intended use, design, configuration, installation and operation is linked and documented over the lifetime of a system. 

Step 8 Method or analyzer qualification Qualify the method on site that is, assess the ability of the method as practiced to meet the original technical requirements such as speed, accuracy, and precision. This is best done jointly by the project manager and the receiver (who is the ultimate owner). 

The developer (the person who did the installation and model development) leaves too soon - voluntarily or otherwise. The developer generally needs to maintain involvement well into the long-term prove-out or qualification phase (Step 8). Plant personnel who inherit process analyzer systems before qualification is complete may experience extreme levels of frustration, especially if they have no previous NIR experience and were not involved in the earlier stages of the project. Another way to state this factor is The business fails to adequately staff the project. 

IFPATma is a not-for-profit consortium of manufacturers/suppli-ers dedicated to the advancement of quality systems for PAT in the pharmaceutical and related industries. The organization has a goal of standardization of practices for process analyzers and reducing the sensor qualification burden on pharmaceutical companies. Its efforts are aligned with ASTM E55 activities and with other organizations having similar goals. 

The analyze phase of the project consists of the activities which are typically associated with , including identification and assessment of potential sensor technologies, method development, qualification, and validation. In addition, designed experiments (DOE) or data-mining exercises may be performed to... 

Beyond the ROI issues, one of the premises for the use of advanced process analyzers is improved product quality. For many industries, and in particular industries close to consumers, there is the need to define procedures and installation qualification/oper-ational qualification/performance qualification (IQ/OQ/PQ) issues, good laboratory practice and good manufacturing practice (GLP/GMP), audit trails, etc. Such requirements open the door for the use of improved analytical methodology, which can be readily provided by the implementation of good process analyzer technology. 

Qualification protocols are written documents prepared before conducting the qualification, describing the features of a particular application or item and how it should be tested. Qualification protocols identify the objectives, methods, and acceptance criteria for each test function contained in the applicable specification deliverable and identifies who is responsible for conducting the tests. In addition, the protocols should also specify how the data is to be collected, reported, and analyzed to determine if the acceptance criteria were met. The protocol should be reviewed by personnel with an appropriate understanding of computer systems and the functionality of the indicated system. Following the review, qualified personnel must approve each protocol in accordance with the company quality assurance procedures. In the software engineering world, qualification protocols are equivalent to test procedures. Traditionally the scope of the qualification protocols encompasses the following ... 

Adsorption is sometimes invoked not only as a factor in geochemistry but also as a laboratory nuisance. Analyzed samples are often found to have a superficial or loosely bound component ascribed to air contamination, which is frequently described as adsorbed on the sample. Without further qualification, this makes little sense. An air contamination effect certainly exists, as can be inferred clearly when an intrinsic sample gas is isotopically distinct (cf. Section 2.4), but whether adsorption is responsible or even involved is questionable. In all such noble gas analyses, a necessary step is storage in laboratory vacuum before gas extraction. By definition, adsorbed gas is desorbed under vacuum. The relevant factor is the timescale required... 

In sec. II.2.3d immersional enthalpies were analyzed for binary liquid mixtures, including dilute solutions. All quantities on the r.h.s. of 15.2.6bl are operational, with the qualification that by virtue of the measuring procedure a = a(adv) and depend on the history, (how dry is the solid prior to immersion ). 

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