UK – Guidance for ‘specials’ manufacturers

The purpose of this document is to provide guidance for manufacturing specials (MS) licence holders in the interpretation of good manufacturing practice (GMP) requirements that should be applied when manufacturing unlicensed medicines.

This includes guidance on the appropriate standards for the manufacture of aseptically prepared products under an MS licence using essentially closed systems.

This document was first published in September 2013. It has now been updated based on experience during inspections and stakeholder feedback…