Pharmaceuticals is a human-critical industry that widely impacts one's life and well-being. Regulatory bodies have introduced and enforced various checks at different stages of pharma drug manufacturing to ensure quality and safe products.
Acceptance tests are quality checks performed before any equipment is made part of the production process in a manufacturer's facility to enforce quality in the procured equipment and to make sure the equipment is capable of delivering the quality and efficiency for which the buyer has paid.
It consists of various tests to check the equipment's current state. It also helps the manufacturer and buyer determine the feasibility of producing the required output and completeness of equipment and detect any discrepancy before the equipment officially becomes part of the production process.
According to best practices and guidelines, the acceptance test is performed at two locations - at the manufacturer's site, known as Factory Acceptance Test - FAT, and after it has been shifted to the buyer's location, known as Site Acceptance Test - SAT.
Let's briefly discus each
What is a FAT?
Factory Acceptance Test - FAT is a series of tests performed on equipment to verify its design, operation, physical structure, software system and other components according to the agreed specifications.
FAT is performed at the equipment manufacturer's location before shifting equipment to the buyer's location. Its main aim is to point out any deviations or discrepancies before moving the machine to the buyer's location.
Its importance, apart from regulatory and quality, significant faults or deviations not possible to rectify at the buyer's location, (due to reasons such as unavailability of cortical parts, expertise or simply because the buyer has paid the manufacturer, and it is its responsibility to remove all deviations before shifting to the buyer) can be identified and solved.
Another main reason is that once shipped, addressing the issues and unique requirements can become costly for the equipment manufacturer and could lead to profit losses. In case of major faults, the buyer rejects the machine, it is costly and difficult to transport the machine back to the machine manufacturer location
The FAT is performed by a comprehensive team from the equipment buyer and comprises members from all critical departments of the buyer pharma organization.
How FAT is performed?
As mentioned above, FAT is performed at the equipment manufacturer's site. It takes detailed planning and scheduling by the manufacturer and the buyer, summarized below.
• When the buyer finalizes the equipment specifications, the manufacturer provides an estimated timeline for the equipment readiness. If there is any change in the timeline, the manufacturer informs the buyer in advance.
• In the meantime, the buyer and manufacturer both work on the checklist. Any party can prepare it, but in most cases, the machine manufacturer must organize it in an approved and standard format.
• The checklist is prepared based on the agreed specifications of User Requirement Specifications - URS and is reviewed by both parties.
• Upon completing equipment manufacturing, the manufacturer informs the buyer and prepares for FAT at its location.
• The equipment buyer forms a team to visit the manufacturer's site. The team consists of personnel from all the critical departments that are practically involved and have expertise in machine operation. Typically, personnel from the production, engineering and quality departments must have their viewpoint. During FAT, there is a limitation to including personnel due to travel-related issues. So, it is better to select personnel wisely.
• The team visits the manufacturer's site and performs FAT according to the agreed-upon checklist, which is documented for the final report and future reference.
• After the test, a report ...
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