Utility system validation

C. Utilize the following guideline to determine the appropriate extent or depth of the system validation effort ... 

Validation of Utility Systems, Test Functions, and Acceptance Criteria... 

Validation Team A well-defined validation team with a well-written description of responsibilities is required and assures the adequate realization of the validation tasks. A validation team should be composed by different responsibilities responsible-of-validation team, team leader, archive manager, test coordinator, quality assurance member, tester, and witness. The responsible-for-validation team elaborates and approves the VMP, protocols, and reports. The team leader should be responsible for the computer system validation and utilization. An archive manager is responsible for the management of all computer system validation documents. The test coordinator is responsible for the computer system test and coordinates the elaboration and operation of tests for evaluating the performance of the computer system. A quality assurance member is required to periodically inspect and train the personnel and review all the validation documents. The tester is responsible for the execution of the tests required to perform the validation protocol. The witness is responsible for observing and reviewing the operations of the tester. 

Running these in series and in parallel, much time can be conserved. The three stages with respect to equipment qualification are sometimes referred to as Equipment Validation, comprising IQ, which ensures that a piece of equipment has been correctly calibrated and installed in accordance with the equipment manufacturer s recommendations (proper voltage, amperage, clearance from wall, exhaust requirements, etc.). It is important to understand that IQ is also required for all utility systems. In most instances, once... 

Consider an example in which validation (performance qualification) of a utility system has been mandated. The responsible resources reluctantly charge right in and begin validation. In the first week of testing, they uncover a sampling point that is not accessible. The protocol has committed validation personnel to collecting samples from this inaccessible point. If those responsible for validation had communications with other plant personnel, they would have... 

Facility changes Utility changes Validated system changes Personnel turnover and loss... 

Qualification activities are normally associated with buildings, facilities, utility systems (e.g., water, air handling, Clean-in-place/Steam-in-place (CIP/SIP), and compressed gases) major equipment (including laboratory instrumentation), whereas validation likely is in reference to those confirmatory tasks related to processes and analytical methods. In simplistic terms, validation (and qualification) can be defined as documented evidence that a process, activity, or piece of equipment can consistently meet its predetermined acceptance criteria and quality attributes. This section will be dedicated towards outlining the requirements for validation of manufacturing processes, as... 

Seals are those elements that create or maintain process boundaries between system components and/or subassemblies in order to ensure system integrity in validated process and utility systems. Seals must be biocompatible (able to be in contact with bacteria or mammalian cells without interfering with their metabolism or ability to live and multiply), must be corrosion and permeation resistant, their surface finishes must be free of molding imperfections and foreign matter on surfaces within the sealing area, and shall not generate particulate that may entrain the product. 

Most basic validation activities within the cGMP pilot plant are identical to those expected in practice in a manufacturing facility. A validation master plan should be developed that addresses the design specifications and qualification, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of all major utility systems, process equipment, and computer control systems. Installation and commissioning data should be retained as part of an engineering documentation package. A workable... 

After obtaining new licences from Japanese government, some simulation tests of abnormal transients caused by the nuclear heat utilization system which will be connected to the HTTR are planned in order to contribute the design of the nuclear heat utilisation system. The test results will be utilized for the validation of analytical codes as well as both of the HTTR-IS system design and the future VHTR design. Two kinds of simulation tests are planned. 

Changes should be controlled in accordance with a SOP as changes may have an impact on a qualified utility, system or piece of equipment, and a validated process and/or procedure. 

Validation is complete for all utility systems that support the equipment or process, and for all equipment that supports a process. 

This chapter provides a summary of the key validation test functions and acceptance criteria for each utility system. These are provided as a guideline for those involved in the validation of ABC Pharmaceutical. Approval of this Master Plan neither provides approval of these test functions and acceptance criteria nor does it limit the test functions and acceptance criteria included in any protocol. Final approval of test functions and acceptance criteria is made by approval of the Installation, Operational, and where applicable, Performance Qualification protocols. 

Validation of utility systems. Define test functions and acceptance criteria for the utilities, including workmanship. 

Civil work Drainage system Validation of utility systems Test functions and acceptance criteria... 

Utilities—There is very little difference between utility systems for a sterile bulk plant and those found in a typical BPC facility. The only differences might be utilities uncommon in a BPC plant such as water for injection and clean steam. The validation requirements for these systems have been well defined in the literature and need little mention here. 

The Pearl GTL plant consists of more than 80 separate process units for 2 separate production trains and common utilities. Modeling the whole plant and creating a complete virtual planf was neither considered feasible nor a requirement and the approach was therefore to make a fit-for-purpose MPDS. Approximately 35 units of 1 single train were identified as requirement for testing, validation, simulation studies and operator training. These units form the heart of the plant and include all major process and utility systems. Despite this reduced fit-for-purpose modeling scope the Pearl GTL MPDS is still one of the largest simulators in the world. 

In addition to reducing new development, this approach substantially reduces cost and time in fulfilling system validations. As a result, commercial prototype demonstrations can be pursued at technical and financial risks acceptable to the vendors and utilities willing to share public interest in the GTHTR300 deployment. 

Utility systems such as water for injection (WFl). clean steam, clean-in-placc (CIP) solutions and sterile process air must be similarly proven. Also the building system itself has to be validated. Many bioprocess operations which contain potentially hazardous materials are operated in closely-controlled negative pressure enclosures with filtration of exhaust ventilating air. Sterile and particularly parenteral products arc processed in clean rooms which are maintained at positive pressure with filtered incoming air. Validation of building control systems and of personnel changing facilities and systems of work are necessary to meet CMP requirements. Manuals for formal test procedures are required to validate these activities. 

Generate and maintain an inventory of all systems utilized by the organization, categorizing them as regulated and nonregulated systems. Identify prospective validation or retrospective evaluation needs for each system and record the current validation status. 

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