Amneal, USA
Fabtech Technologies has worked on the Amneal pharmaceutical manufacturing facility in the United States. It is one of the projects in the portfolio on this site. It is the only one in North America.
This is not the Amneal Pharmaceuticals website. If you are looking for Amneal Pharmaceuticals itself, for their headquarters, locations or contact details, this is Fabtech Technologies' site. We cannot help you reach them.
Why a US-market facility is different
This section describes projects of this type in general. It does not describe what was delivered at this facility.
A plant that supplies the United States is designed to meet what the FDA expects.
The FDA (US Food and Drug Administration) is the US regulator for medicines. Compared with most other markets, the main practical difference in the United States is the inspection.
The written standard is not the main difference.
An FDA pre-approval inspection is the FDA's visit before it approves a product. It checks the plant and its records together.
Data integrity counts as much as the engineering work. Data integrity means knowing who recorded what, and when, and whether the record could have been changed.
This means some decisions are made earlier. The control systems must meet 21 CFR Part 11, the US rule for electronic records.
You cannot add this later as an option on a specification sheet. It is a choice made at the design stage.
The same is true of how qualification evidence is made and kept. The design team plans airflow schemes, pressure cascades and the routes for materials and people on paper.
A pressure cascade means each room is held at a set air pressure, higher or lower than the room next to it. All of this is done long before an inspector sees the room.
In the same published portfolio, Misom Labs in Malta is the matching reference for the European Union.