Performance qualification , Good

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. 

The performance qualification (PQ) protocol should document that the entire system spectrometer and software can perform as required. Typically, it is good practice to have a mock method included in the PQ protocol. It is also important to verify that the system will perform as expected under a variety of circumstances. 

Instrumoit qualification is a necessary prerequisite to method develr ment and validation. In essence, if the instrument is not functioning properly, then the results cannot be considered good. Instrument validation includes four steps design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) [80]. These will be presented separately. 

A set of a well-formulated User Requirements Specification (URS), Functional specifications and Detail specifications has key importance proceeding any purchase (see Sect. 34.15). A good URS is used in the performance qualification and relates the actual production capacity and variety to the required machine qualities. 

In brief, the auditor has to be qualified by lATF to perform the audits and, to be eligible for qualification, the auditor has to be sponsored by an lATF-approved certification body that is subject to witness audits performed by qualified auditors from vehicle manufacturers. Such measures will inevitably improve the quality of certification offered by certification bodies and will be good for the global automotive industry. 

The qualification just stated should also preferentially be performed on prepacked columns to ensure that the column fulfills the users own specifications. Furthermore, it is good practice to run the qualification periodically and after cleaning and stand still. 

Calibration, in current Good Manufacturing Practices (GMP) terminology, refers to instrument qualification or performance verification... 

Calibration, in current Good Manufacturing Practices (cGMP) terminology, refers to instrument qualification or performance verification of the HPLC. Note that neither any internal instrumental adjustment nor detector response curve for quantitation is intended here as in the common usage of the terminology. In most pharmaceutical laboratories. 

Establish Personal Qualification Pathways Good business practice, as well as CFR 21 211.25, mandates that each employee possess the education, training, and experience to enable him or her to perform assigned functions in a safe and effective manner. The training plan must contain a policy allowing personnel to demonstrate their qualifications. This should cover training and supervisory personnel as well as those directly involved with operations. 

Proper functioning and performance of equipment and computer systems play a major role in obtaining consistency, reliability, and accuracy of analytical data. Therefore, equipment qualification (EQ) and computer system validation (CSV) should be part of any good analytical practice. It is also requested by FDA regulations through the overall requirement that equipment must be suitable for its intended use. While in the past, equipment qualification and computer validation focused on equipment hardware and stand-alone computer systems, recently the focus has been on network infrastructure, networked systems, and on the security, authenticity, and integrity of data acquired and evaluated by computer systems. 

For both nuclear and solar systems, appropriate material selection will be essential. A qualification programme for high temperature metallic materials must demonstrate their good long-term performance. In the nuclear case, candidate materials will be exposed to helium of 1 000°C with impurities such as CO, C02, H2, H20, CH4 and to neutron irradiation. The experience gained so far has disclosed that the technical solution of material problems requires further efforts in the future. 

The Technical Director is responsible for compliance with Good Manufacturing Standards. He shall have the legal qualifications. He.shall have experience in the production and control of drugs, so as to permit him to have prompt understanding of the practical problems encountered in the performance of his functions and to make independent professional decisions founded on the application of scientific principles as well as on effective legislative standards. 

For that purpose, a number of studies and analyses were performed including metal samples tests, and they proved the applicability of the LBB conception. As a result, acoustic leakage control system ALUS was installed, covering also surge line DN 200 pipes, and the system shows good results. Additionally for the same purpose, two new systems of that type are now in process of qualification. 

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