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PHSS Annex 1 Impact Statement 2017
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Assurance of sterility has always been a priority for regulators and industry / healthcare professionals and of course of prime importance to the patient.

Annex 1 has served its purpose well, having been first issued in 1972, with 5 subsequent partial revisions (1996, 2003, 2005, 2007 and 2009). A full revision was first proposed 2012 and then re-issued 2014.

A Working Group was formed from PIC/S / EMA to work on the full revision. (PIC/s and EU GMP is now essentially aligned and PIC/s membership now includes new major players outside of the EU such as US FDA and Japan’s MHLW / PMDA)

In recent years there have been a number of inspections of companies manufacturing within EU and USA which have identified unacceptable assurance of sterility and subsequent risk to patient. These have led to withdrawal of manufacturing licences and multi batch recalls. Inspectional observations in these and less serious cases have included:


·         Poorly designed facilities and / or processes

·         Poorly controlled monitoring regimes

·         Investigations and risk assessments

·         Lack / application of knowledge

After several delays the we now fully expect the full revised Annex 1 to be issued for a 3 month public consultation during  Q1 2017 and for the final document to be published soon after the 3 month consultation period.


Click on the below file for information.


PHSS Annex 1 Impact Statement

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PHSS Annex 1 Impact Statement written by Malcolm Holmes released January 2017
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