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OOS Investigation Tools: Streamlining Out-of-Specification Investigations

OOS Investigation Tools: Streamlining Out-of-Specification Investigations Out-of-specification (OOS) events are critical occurrences in pharmaceutical manufacturing, representing deviations from established specifications and potentially impacting product quality and patient safety. Efficient and thorough investigations are crucial to identify root causes, prevent recurrence, and ensure product compliance. This post explores essential tools that streamline OOS investigations. Key Tools and Examples of OOS investigation Tools: 1. Electronic Data Capture (EDC) Systems:   These systems are crucial for managing clinical trial data, but their principles of data integrity, audit trails, and secure storage are highly relevant to OOS investigations. Veeva Vault EDC: Veeva is a well-established name in the life sciences industry. Vault EDC is a cloud-based platform specifically designed for clinical data management. Its features like audit trails, electronic signatures, and version contro...

Factory Acceptance Test of Rquipment (FAT)

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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