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OOS Investigation Tools: A Comprehensive Guide

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Introduction In the pharmaceutical industry, Out-of-Specification (OOS) events can have significant consequences, impacting product quality, patient safety, and regulatory compliance. Effective OOS investigation is crucial to identify the root causes, implement corrective actions, and prevent future occurrences. This blog post will explore various tools and techniques employed in OOS investigations. Essential Tools for OOS Investigations Data Analysis Tools: Statistical Software: Leverage software like Minitab, Excel, or specialized statistical packages for data analysis, trend identification, outlier detection, and process variability assessment. Quality Management Systems (QMS): Utilize QMS software to centralize and manage quality data, facilitating efficient data retrieval, analysis, and reporting during investigations. Electronic Batch Records (EBR): Employ EBR systems to capture and store detailed manufacturing process information, aiding in tracing back steps, identifyi
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Factory Acceptance Test of Rquipment (FAT)

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Factory Acceptance Test

The pharmaceutical manufacturing process is full of equipment. Multiple types of equipment are being utilized for production of medicines. It was a traditional approach to handmade medicines. But now in the last few decades, the traditional approach is getting diminished and getting replaced with the latest technologies. More on the latest technology runs in auto, hence the qualification of technology, system, software, equipment, machinery is an essential criterion. 

Factory Acceptance Test

What is a factory acceptance test? 

The factory acceptance test is nothing but a set of tests that are executed to verify the developed equipment/system meets its design parameters. 

When factory acceptance test is performed? 

After completion of design qualification, the factory acceptance test is performed at vendor's location i.e. where the equipment is under development. 

Why factory acceptance test is carried out? 

To verify that, after assembling, the equipment delivers the performance as per predefined parameters, user requirement specification, and design qualification. 

What are the equipment selection criteria for the factory acceptance test? 

The pharmaceutical industry requires multiple equipments to carry out the manufacturing process. This equipment before usage is qualified and then used. There are pre-defined cGMP and ASME parameters and equipment is supposed to comply with these parameters. If successful, then the equipment is said to be qualified. 

However, for all equipment factory acceptance test is not mandated. That equipment are customized and prepared considering the site’s design requirement in this case only the factory acceptance test is performed. 

Multiple times it was observed that the equipment’s customized and developed as per site requirement. But failure to do the factory acceptance tests can lead to qualification failure at the site. If qualification failure is observed during the factory acceptance test, then the complete responsibility will be of the factory. But, if qualification failure is observed at the site end, the responsibility of the same including cost implications would be at site. 

Hence factory acceptance test is one type of preventive measure. Hence always it is performed at the vendor location i.e. at the factory. 

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