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.
Areas where changes have been made are listed in the appendix.
Some changes may have an operational impact so there will be a grace period to allow the changes to be implemented.
We expect most changes should be implemented within 3 months. However due to the significance of the following changes these should be implemented by 6 months after the publication of this document:
3.3.6 - Cleaning validation
3.5.19 – Pooling (except the requirements for pooling batch records and conduct of media fill studies reflective of the process, which should be implemented within 3 months)
3.5.20 – Disinfection using sporicidal agents
3.5.27 – Eye drop manufacture
3.6.9 – Identification of microorganisms
Due to the significant impact of these changes on sterility assurance, licence holders should ensure that, where relevant, interim risk reducing actions are considered during the 3 to 6-month implementation phase.