Equipment system validation

Equipment System Validation The GMP has special features regarding the equipment, setting several points for the validation, such as design qualification, installation qualification, operational qualification, and performance qualification. Each point must be given in a different document, so four documents must be generated for each equipment. Without any of these documents, the equipment cannot be considered adequate for GMP purposes. GMPs do not refer equipment validations nonetheless, they refer these four items, and therefore, equipment can only be considered validated after the approval of these four documents. 

The final step of method development is validation of the HPLC method. Optimisation of chromatographic selectivity [110], performance verification testing of HPLC equipment [591], validation of computerised LC systems [592] and validation of analysis results using HPLC-PDA [34] were reported. The feasibility of automated validation of HPLC methods has been demonstrated [593]. Interlaboratory transfer of HPLC methods has been described [594]. 

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... 

Facilities and Equipment System This includes (1) buildings and facilities along with maintenance (2) equipment IQ, QQ, calibration, maintenance, cleaning, and validation of cleaning processes and (3) utilities such as HVAC, compressed gases, steam, and water systems. 

The validation master plan is a summary document stating the intention and the methods to be used to establish the adequacy of the performance of the equipment, systems, controls, or process to be validated. It is approved by the quality assurance, validation, production, and engineering groups. 

A validation protocol is a document that describes the item to be qualified, the tests and checks to be performed, as well as the results that are expected to be obtained. It is a file in which the records, results, and evaluation of a completed validation program are assembled. It may also contain proposals for the improvement of processes and/or equipment [1]. Validation protocols are important in ensuring that documented evidence is taken which demonstrates that an equipment item, a system, a process, or a method consistently performs at a specified level... 

A computer system is composed of software and hardware, equipment, a processor, and a user, and it is used to execute a specific procedure. Regardless of whether the computer system is developed in-house or by a contractor or purchased off the shelf, establishing documented end-user requirements is extremely important for computer systems validation. Without first establishing end-user needs and intended use, it is virtually impossible to confirm that the system can consistently meet them. Once established, it should obtain evidence that the computer system implements those needs correctly and that they are traceable to system design requirements and specifications. It is important that the end-user requirements specifications take into account predicate rules [12]. 

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. 

Qualification of equipment and validation of computer systems are not one-time events. They start with the definition of the product or project and setting user requirement specifications and cover the vendor selection process, installation, initial operation, ongoing use, and change control. 

Equipment qualification covers the entire life of a product. It starts when somebody has an idea about a product and ends when the equipment is retired. For computer systems validation, this ends when all records on the computer system have been migrated and validated for accuracy and completeness on a new system. Because of the length of time and complexity, the process has been broken down into shorter phases design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) [2]. The process is illustrated in Figure 17.1. 

Steps for equipment qualification and computer system validation with examples on type and extent of testing... 

Documentation must be complete. On completion of equipment qualification and system validation, documentation should be available that consists of the following ... 

The most important factors for the entire process of equipment qualification and computer system validation in analytical laboratories are proper planning, execution of qualification according to the plan, and documentation of the results. The process should start with the definition of the analytical technique and the development of user requirement and functional specifications. For computer systems, a formal vendor assessment should be made. This can be done through checklists and vendor documentation with internal and/or external references. For very complex systems, it should go through a vendor audit. 

A validated manufacturing process is one which has been proved to do what it purports or is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment, systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. 

Whether a control system comprises distinct instruments for nominal control functions and process monitoring, or an integrated control system, a nominal set of control function tests are necessary. The tests described encompass both controller capability and equipment performance. These tests may be completed during the FAT as part of a separate computer system validation. 

Change control—to ensure any change to the system—or to other equipment that may affect system use—is properly assessed, documented, and progressed with regard to GMP compliance and system validation... 

Other specialists (e.g., packaging operations, appropriate for specific processes, systems, or equipment undergoing validation)... 

Computer systems validation, as established in 21 CFR Part 211.68, Automatic, Mechanical, and Electronic Equipment, is one of the most important requirements in FDA-regulated operations and an element of the system life cycle (SLC). In addition to the testing of the computer technology, other verifications and inspection activities include code walkthroughs, dynamic analysis and trace analysis. These activities may require 40% of overall project efforts. 

Note This activity is the culmination of computer systems controlling manufacturing equipment and is out of the scope of computer systems validation. This qualification may be performed by QA or R D and only on manufacturing systems. 

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