Qualification approaches

Derived from combining Valid Information sources 

Derived from Good Data from Validated Software 

Derived from relevant samples using validated methods developed on qualified equipment 

The role of the instrument in providing the integrity of data is fundamental to the end result. If the analytical practitioner cannot have faith in the reliability of the basic analytical signal within predetermined limits then the information generated will be worse than useless. Reliability of the data quality should be linked to performance standards for both modules and systems as well as having a regular maintenance programme. 

An alternative and increasingly applied approach, particularly from the regulatory bodies, is from the other direction, i.e. top down . This approach is known as the 4Qs model, DQ, IQ, OQ and PQ which are  

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Qualification Approaches If an analytical instrument is comprised of different functionally discrete modules, a modular approach to qualification testing that focuses on the specific operations of the individual module can be suitable for certain aspects of some operational testing (such as the flow rate precision and accuracy testing of a HPLC pump and the temperature accuracy column compartment). 

Validation (policy, documentation, qualifications, approaches to process validation, periodic review of validated systems, cleaning validation, and analytical methods validation)... 

If electronic SOPs are managed through a validated Electronic Document Management System (EDMS), it could be argued that it is not necessary to validate the intranet environment as the EDMS qualification would have effectively qualified it. The intranet would only have to be validated in its own right where its functionality is not limited to library viewing and read-only access. The qualification approach to EDMS is discussed in Chapter 34 Case Study 16. 

Strategies for Down-Scale Process Qualification Use of Down-Scale Process Qualification Approach for... 

In order to address this fundamental limitation of qualifying the reliability with only a single mechanism model, we developed a special multiple-mechanism qualification approach that allows companies to tailor specifications to a variety of customer s needs. 

The reactor physics uncertainties with this compact, reflector-controlled fast reactor necessitate a reactor physics qualification approach, including fundamental integral cross section testing, representative material and geometry critical testing, cold and hot critical physics experiments, and detailed physics testing on a ground prototype. 

This approach enables also to substantiate acceptance criteria for detection and qualification limits in impurity control method validation. 

Consider the practicality of assembling and managing people with these kinds of qualifications in your company this may help you determine whether a companywide approach is feasible. Single divisions may offer stronger possibilities, since they usually have more common manupcturing processes and equipment. 

Installation qualification is aimed primarily at new instruments. This is the stage when the checks are carried out to confirm that the instrument received is as specified and correctly installed in the selected environment. This includes both hardware and software. It may be convenient to use a check-list approach to this phase as that ensures everything is checked. This stage covers the installation up to and including its initial response to power, if that is relevant. In addition it may be appropriate to repeat aspects of IQ following relocation or upgrades of instruments. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Quantitation and qualification of large molecules follow similar principles as procedures for small molecules but involve different foci and approaches. The quantitation of proteins and peptides includes relative and absolute amount evaluations. Most proteomic applications in drug discovery are concerned with relative abundances of proteins. 

The high level of safety and reliability required of nuclear power stations has meant that systematic estimates of polymer lifetime have been performed more widely here than in any other industry. The approach is described in Section 5.3. Many applications of polymers are in locations that cannot be monitored by regular inspection. The practice has been to subject polymers in these regions to independent assessment or environmental qualification , a process in which their potential degradation mechanisms are identified within a worst case environment of 40 °C and high humidity. If the predicted lifetime of a component is less than the design life of 40 years a schedule is laid down for its replacement. 

There are no calibrator tablets available for this apparatus. The approach to performance qualification would be as outlined previously, that is, to determine the critical parameters, which in this case will include dip rate and volume control. 

However the latest thinking provided by the United States Food and Drug Administration (FDA) in the Guidance for Industry for Quality Risk Management suggests that all qualification activities for analytical instruments should be performed using a risk-based approach. 

To this end the following guideline describes a general approach toward risk management for a laboratory instrument and then applies it to the performance of the operational qualification of a CE instrument. Tests then need to be devised in order to determine the suitability of the instrument for its intended use and to fulfill those user requirements that have been defined by the operator. 

Method qualification is based on ICH method validation guidelines. Method type (purity or identity) will dictate the level of qualification testing necessary. Several strategies for method qualification and validation exist and are based on needs, resources available, and the project timeframe. One approach is to perform minimal development and qualification, which may be necessary for projects with shorter timelines, but it may place more burden and risk on future validation activities for robustness testing, and can result in failure. As discussed in Chapter 4, an alternate approach would invest more time and resources into method development, followed by extensive qualification and robusmess testing to determine if further development is... 

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. 

Because the FCV algorithms are basically a non-statistlcal approach to cluster analysis it was not possible to attach estimates of mlsclasslfication error for step 2a). Similarly, the amount of data which could be collected for the investigation was not considered sufficient for use in defining confidence levels for the absolute values of plant emissions determined by step 2b). These qualifications need to be taken into consideration when interpreting the results of the investigation. 

The standard of any facility of operation is highly dependent upon the quality of the design and, therefore, the staff employed to undertake the work. A design qualification protocol, or report document, should detail and record the disciplined, structured approach followed. This will provide a useful lead into the installation qualification (IQ) stage. 

The operational qualification of computerized systems consists of a group of tests, pooled in functional checks. The tests are carried out step by step on each component. The general approach used is of the gray-box type. More precisely, study the input and output data transmission at intermediate points. The structure of the operational qualihcation may be standardized for all operational qualihcation of computerized pharmaceutical equipment. 

Validation Approach and Deliverables Outhne the required documents, qualification testing, and reports to be included in the validation project. The deliverables should be based upon the complexity and the risk associated with the intended use of the system. The dehverables will highlight the acceptance criteria to demonstrate that the system has met the requirements for its intended use. 

When it comes to performance qualification, a holistic approach must be taken to test the analytical system with all the necessary modules working together to deliver the intended applications as specified in the user requirement (Figure 3). The proper functioning of each individual module of the analytical system does not... 

FIGURE 3 Modular versus holistic approach for qualification. 

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