Synopsis:
“Suitable for the intended purpose/activities” is a core regulatory expectation for all pharmaceutical manufacturing equipment, and qualification is the documented proof that this is achieved. The qualification lifecycle starts with a User Requirement Specification (URS) document followed by a Functional Specification (FS). Test Scripts are executed in IQ, OQ and PQ documents to demonstrate that the requirements noted in the URS are met. Because running IQ/OQ/PQ scripts at the manufacturing site is time-consuming and the responsibility falls only on the drug manufacturer, some of the effort can be shared with the vendor via Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). ValDoc Pro can streamline this process and build better compliance.
Regulatory Guidelines:
121 CFR 211.63 states that “Equipment must be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use”[2]. While the FDA recognises the advantages of FAT and SAT (mentioned in presentations by the FDA), there is no guideline that discusses this. EU GMP Annex 15 & PIC/S explicitly state, in sections 3.4-3.7, that:
- Equipment, especially if incorporating novel or complex technology, may be evaluated, if applicable, at the vendor prior to delivery.
- Prior to installation, equipment should be confirmed to comply with the URS/ functional specification at the vendor site, if applicable.
- Where appropriate and justified, documentation review and some tests could be performed at the FAT or other stages without the need to repeat on-site at IQ/OQ if it can be shown that the functionality is not affected by the transport and installation.
- FAT may be supplemented by the execution of a SAT following the receipt of equipment at the manufacturing site.
Leveraging Vendor Testing:
The Factory Acceptance Test (FAT) is carried out at the vendor’s site and provides documented evidence that the equipment meets the user requirements and the vendor has fulfilled contractual responsibilities. A well‑planned FAT helps save time during qualification by identifying design issues, functional gaps, and integration problems before the equipment leaves the factory. Sending the equipment back to the vendor to fix issues, especially when they are located across continents, is avoided through FAT. Fat also provides the ability to check internal components of the equipment that one would not be able to reach at the site unless it is disassembled.
It is not necessary that a FAT test be performed for all equipment/systems. That decision is left to the manufacturing site and its policy. For a greenfield facility, a commissioning and qualification (C&Q) plan will direct this strategy. A survey by ECA Academy in 2018 found that FAT is used by 37% of the companies surveyed, while 55% stated “it depends on the complexity of the project”. SAT was found to be used by 49% of those surveyed [5].
Planning and preparation for the Factory Acceptance Test (FAT) are critical because the activity is conducted at the vendor’s site and involves budgeting for extra expenses on both sides. The decision to perform FAT is typically taken very early in the procurement lifecycle, during the development of the User Requirement Specification (URS) for the equipment. The contract signed between the drug manufacturer and the vendor for an equipment includes scope of the FAT, responsibilities and the commercials. The details of what is to be covered in FAT are put down in a protocol and frozen before approval of the design stage. The site and the vendor have to agree on the features/functions to be demonstrated, parameter specification to be met, tests to be carried out, and identify the URS points covered by FAT. The FAT protocol is sent to the drug manufacturer for review. Once approved, then only the protocol can be executed. During execution, the drug manufacturer representative(s) ideally should be present to at least to verify the minimum test requirements and resolve any deviations. During and after the pandemic, many FATs have been conducted remotely, reducing travel and related expenses and making this an attractive option, particularly when organisations can leverage a wide range of digital tools and platforms to their advantage.
The FAT protocol, once executed, is compiled along with attachments and sent to the site by the vendor for review. In most cases, the equipment would have to be disassembled before shipping. The documentation put together details equipment component labels and the process to follow to reassemble these components.
Similar to the FAT, the Site Acceptance Test (SAT) is not a mandatory test to perform. The advantage of SAT is time savings. A successful execution of the SAT protocol provides assurance that the equipment works as per specification post-transportation to the site. While infrastructure, utilities, interfaces, etc, are defined in advance and agreed upon, surprises may crop up. The SAT protocol also rechecks issues found during FAT. These should be addressed before IQ begins. In addition, the presence of the vendor’s team at the site speeds up testing, as that machine is very well known to them.
The SAT process follows the same overall approach as the FAT, but is performed at the manufacturing site rather than at the vendor’s facility. Whether a SAT will be performed should be defined in the C&Q plan and, preferably, specified in the URS and subsequently reflected in the contract. SAT is led by the site, along with the vendor’s project/commissioning/service staff. The SAT protocol is normally drafted by the vendor or the project engineering/validation team.
A decision that the site needs to take is whether they would like to leverage what was tested in FAT and SAT. Most sites leverage the data from these tests. The SAT protocol has many tests that overlap with what one would carry out under IQ and OQ protocols.
Accelerating FAT and SAT Efficiency with ValDoc Pro:
ValDoc Pro is an easy to use Qualification management application that assists companies in digitizing their qualification workflow, from URS onwards through the entire lifecycle. Its role-based access and real-time collaboration features enable vendors and manufacturers to coordinate FAT and SAT seamlessly. Following are some of the advantages:
- Vendor Access: Vendor can create, obtain site approval and execute FAT protocols within ValDoc Pro, with controlled access to designated folders/files.
- Site Review and Approval: The FAT protocol and FAT report can be submitted for review and approval online.
- Seamless Flow: Generating the protocol by the vendor, review, execution and compilation all can be carried out seamlessly in ValDoc Pro.
- Sequential: ValDoc Pro ensures that the SAT protocol cannot be executed until the executed FAT report has been approved. This ensures that the SAT protocol captures all relevant tests.
- Traceability Matrix: ValDoc Pro maintains a continuous link from URS through FAT/SAT to IQ/OQ/PQ, demonstrating to regulators that all user requirements were tested and all deviations addressed.
Conclusion:
Compared with relying solely on traditional IQ, OQ, and PQ, integrating FAT and SAT into the equipment qualification strategy allows issues to be identified earlier at the vendor and manufacturing site, limits risk, and reduces the amount of testing and troubleshooting that must be compressed into already busy commissioning windows. This upstream focus not only improves the quality of delivered assets but also frees site resources to concentrate on value-added verification and routine operation rather than firefighting late-stage gaps. ValDoc Pro-enabled FAT and SAT give pharmaceutical manufacturers a more efficient and compliant path to equipment qualification by moving protocols into a digitized, collaborative environment and enabling options such as Remote FAT, so teams can shorten timelines, reduce on-site disruption, and strengthen data integrity while maintaining full traceability from URS through lifecycle maintenance. In a landscape where each site-based role carries a greater workload, embedding FAT and SAT within a robust application like ValDoc Pro is not just an efficiency gain, but a strategic necessity for sustaining reliable, inspection-ready manufacturing.
[1] FDA. Process Validation: General Principles and Practices. U.S. Food and Drug Administration.
[2] “U.S. Food and Drug Administration. 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals, §211.63 Equipment design, size, and location.”
[3] European Commission. EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, EudraLex, Volume 4, Annex 15: Qualification and Validation. In operation since 1 October 2015
[4] PIC/S. Guide to Good Manufacturing Practice for Medicinal Products, PE 009 (current version), Annex 15: Qualification and Validation
[5] ECA Academy. FAT & SAT not frequently used as Part of Qualification – ECA Modern Qualification Survey Results. GMP News, gmp-compliance.org (2018)
