Qualification automated systems

System qualifications are quality checks. They are a part of the validation of a product. Validation is defined as, Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes (5). A product that is validated is considered to be of much higher quality than one that is not validated. Automated dissolution systems need to be validated as a requirement of their use in regulated laboratories. 

Automated qualification software is yet another area of CDS development that has been affected by regulatory compliance. When you look at today s CDS solutions, it is typical to see the system providing direct digital control of the instrumentation. Many CDS manufacturers offer software tools that are capable of automating the installation qualification (IQ) and operational qualification (OQ) process. In addition, some manufacturers also offer software that can automate the performance qualification (PQ) for the various forms of instrumentation that it is capable of controlling. These automated software tools are not only time savers for the laboratory, but they also help to properly document the system qualification effort. 

Waters (1993) Guide for the system qualification of HPLC automated with detection UV... 

While automated tools and software are available for system qualification, method validation, and system suitability testing, achieving regulatory compliance for an HPLC laboratory remains a complex, costly, and time-consuming process. Many companies are adopting a risk-based approach to balance productivity and compliance. For instance, many pharmaceutical research... 

More efficient regulatory compliance with automated tools and software for system qualification and method validation... 

As mentioned in a previous section, one of the goals in implementing an assay robot is to make the manual and automated methods as similar as possible. If this is done successfully, then system qualification becomes a fairly simple proposition. As with automated dilutors, it is recommended to compare to a validated manual... 

International Electrotechnical Commission International Laboratory Accreditation Co-operation Interlaboratory test International Measurement Evaluation Program Information Service for Physics, Electronics and Computing Installation Qualification Institute for Reference Materials and Measurements (Geel, B) Instrumentation, Systems and Automation Society (Research Triangle Park, NC)... 

Validation of automated systems must demonstrate a lack of contamination or interference that might result from automated transfer, cleaning, or solution preparations procedures. Equivalency between the results generated from the manual method and the data generated from the automated system should be demonstrated. Since sensitivity to automated dissolution testing may be formulation related, qualification and validation of automated dissolution equipment needs to be established on a product-by-product basis (8,13) (see also Chapter 12 for a more detailed description of automation issues). 

When designing instrument qualifications for automated dissolution systems, some key considerations are determining the functions to validate, cost, testing using equipment... 

The cornerstone of validation and qualification is testing to a set of specifications. Without specifications, proper qualifications cannot be performed. For an automated dissolution system, the specifications originate from a few sources, which include the USP, the manufacturer s FRS, and the manufacturer s detailed design specifications, which may include HDS and SDS. 

Instrument qualifications should be executed on a scheduled basis that can be determined with the help of manufacturer s recommendations. Automated dissolution systems that are used regularly are typically re-qualified every six months to one year. Re-qualification is also recommended for other reasons including moving equipment or replacing parts. Below is a typical system re-qualification policy. 

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. 

Equipment Qualification (EQ) is a useful endeavor when the lyophilizer is a complex and sophisticated system. Large-scale manufacturing units commonly include multiple automated support operations. These may include steam-in-... 

The validation of a PLC cannot be viewed as a stand-alone operation. PLCs are there for a purpose — to provide automotive functionality. A project Validation Master Plan that details what other validation (equipment qualification, validation of other automated systems) is required. An overall project plan timetable must be in place in order to ensure, e.g., that validation of the PLC does not adversely delay the qualification of important equipment. Where the PLC is to communicate with another PLC embedded into an item of equipment, the link as well as the validated, as well as the individual PLCs, but the link cannot be validated until the software processing the information from the particular I/O point is validated. The deflnition of the boundaries of each validation prevents unnecessary duplication. For PLCs, it is best to use the I/O cards as the boundary. A final check from HMI to the device can then be performed to ensure the system works in its entirety. 

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