Guidance for Specials Manufacturers from the Medicines and Healthcare products Regulatory Agency (MHRA)
(For Manufacturing Specials (MS) licence holders).
Overview
The purpose of this document is to provide guidance for Manufacturing Specials (MS) licence holders in the interpretation of the GMP requirements to be applied when manufacturing unlicensed medicines.
The document includes guidance on the appropriate standards for the manufacture of aseptically prepared products under an MS licence using essentially closed systems.
However, it is important to recognise that all aseptically prepared products where open systems are used, should be manufactured in accordance with the standards outlined in the EU Guide, specifically Annex 1.
This guidance does not replace any of the requirements for unlicensed medicines already contained in Guidance Note 14 (GN 14).
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