FAT protocol (sometimes sent with the “certified for construction” or “issued for correction” package only). General arrangement drawing showing the layout and location of the major components. Drawings showing the layout of the equipment, utilities, and installation requirements. Standard submittal packages include the following: “Certified for construction” documents and drawings are sent for approval by the end user once the design of the equipment is complete. It is often divided into a written order-confirmation letter and submittal package. Predelivery documentation is submitted to the end user before manufacture to ensure that both manufacturer and end user have a common understanding of all requested equipment features, documentation, testing requirements, delivery time, etc. System acceptance test report FAT protocol. System acceptance testing (software test documentation). Control system validation documentation. Chemical delivery system specifications, if separate. Rack and accessories drawings, if applicable. Manufacturing and qualification documentation. Postdelivery documentation, submitted to the end user after the FAT and any corrective follow-up actions are completed, is usually provided in paper or electronic format or both. “Process Validation: General Principles and Practices.” January 2011. “Cleaning Validation Considerations for Automated Washing Systems.” Pharmaceutical Engineering 37, no. M300 analog outputs channels calibration has been performed according toĬonductivity sensor calibration has been performed according to instructionħ70 MAX analyzer and 500 TOC sensor have been set according to instructionħ77 MAX TOC analog output calibration has been calibrated as per 920-514-163 
Pressure transmitter calibration has been performed according to instruction Transmitter calibration has been performed according to instruction 920-514. Sump temperature transmitter and non-recirculated final rinse temperature transmitter and exhaust temperature transmitter Table A: Instrument calibration checklist Document
* Instrument qualification (IQ), operational qualification (OQ), and performance qualification (PQ) Project documentation is divided into two categories: predelivery and postdelivery. The more complete the FAT documentation, the easier it is to execute SAT, IQ, OQ, and PQ activities.
Having approval from a subject matter expert (SME) and quality personnel, at a minimumĬontrol system documentation is normally expected to follow GAMP® 5 Guidelines. Demonstrating the necessary technical capabilities and expertise. Having an acceptable quality system in place (ideally approved by a third party). 
Documentationĭocumentation related to the equipment and the project can generally be provided in the manufacturer’s format as long as the manufacturer meets some basic criteria: 5 We also include a case study to illustrate the advantages of carrying out an FAT.
1, 2, 3, 4īased on our decades of experience, this article presents best practices and critical items to avoid when planning for and executing an FAT for an automated parts washer. A well-planned and well-executed FAT can lead to an easy transition to site acceptance testing (SAT), qualification,* and continual monitoring of the parts washer after delivery. It is also easier and less expensive to correct issues or implement design changes at the manufacturer’s facility. The FAT is performed in production-like conditions at the manufacturer’s site, where testing equipment, utilities, and trained personnel are available to ensure that the equipment functions as designed. User requirement specifications (URS), functional specifications (FS), and design specifications (DS) are all incorporated into the equipment design and manufacture, as shown in Figure 1.
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