Commissioning (FAT/SAT)

Acceptance, or acceptance testing, is an activity outside the context of GMP/GxP requirements and is conducted purely as a commercial activity with the aim of confirming that the scope of supply and functional specifications of the equipment meet the contract specifications, and that the supplier has fulfilled their obligations to the client.

For particularly complex, large, and expensive equipment – common in the pharmaceutical industry – it is advisable to conduct initial acceptance testing at the manufacturer's facility before shipping the equipment to the client. This type of acceptance testing is traditionally called Factory Acceptance Test (FAT). FAT is typically initiated by the client and has an exclusively commercial nature, meaning it is not a regulatory requirement. The goal of conducting FAT is to identify potential equipment issues before it leaves the manufacturer's facility, allowing for quick resolutions and avoiding significant additional costs. Moreover, the successful completion of FAT is often linked to a payment milestone in the equipment supply contract.

The next acceptance activity, conducted at the client's site after equipment installation and start-up, is the Site Acceptance Test (SAT). Like FAT, SAT is also purely commercial and not a regulatory requirement. Upon completing the SAT, a report is usually required as a condition for the supplier to receive the next payment milestone under the equipment supply contract. It is advisable to include a check in the SAT protocol to verify the successful completion of Installation Qualification (IQ) and Operational Qualification (OQ). However, in some cases, the process may be reversed: SAT protocols, provided that the tests were conducted and documented in compliance with GMP requirements, may be included in the validation documentation package, thus becoming part of the qualification tests: IQ and OQ.

Both FAT and SAT can be broken down into the following stages:

Development of the FAT/SAT protocol
Coordination/approval of the acceptance protocol between the client and the supplier
Conducting the acceptance tests based on the approved protocol
Correction of identified deviations
Retesting to confirm the correction of deviations
Completion of acceptance testing.

The specialists at Tarqvara Pharma Technologies have years of experience in conducting qualification, validation, and acceptance tests within the pharmaceutical industry, in full compliance with international, European, and national GMP/GxP regulations and standards.