Proposal guideline by EMA anticipated to replace Eudralex Volume 4: Annex 15 Qualification and validation.
The European Medicines Agency (EMA) is proposing extending the scope of Annex 15, Qualification and validation, currently an optional supplementary guidance for active substance manufacturers.
GMP requirements state that any planned changes to facilities, equipment, utilities and processes likely to affect product quality must be documented and the impact on the validated status or control strategy assessed.
The main proposed change to the annex, initially issued in 2001, is to make it mandatory for active substance manufacturers, “to address the shortcomings identified and ensure quality and safety of medicines”.
[Revisions to Annex 15 are] intended to give [active substance] manufacturers “more oversight and knowledge about their processes and products”
Specifically, this move is intended to give manufacturers “more oversight and knowledge about their processes and products”.
Other proposed changes include amending some of the text so it’s supported by guidance in EudraLex, Volume 4, Part II, as well as revisions that consider ICH guideline Q9 (R1) on quality risk management.
The current revisions were recommended by the agency’s Good Manufacturing Practice (GMP) Good Distribution Practice (GDP) Inspectors Working Group (GMDP IWG) and PIC/S Sub-committee on GMDP Harmonisation.
EMA has proposed the following questions to interested stakeholders:
- What is the current level of use of annex 15 principles in active substance manufacturing in the different sections of the guideline (process validation, cleaning validation, transport validation, investigations, qualification, change control) as well as usage of retrospective or concurrent validation approach?
- What would be the impact of making annex 15 mandatory for active substance manufacturers in the different sections of the guideline (process validation, cleaning validation, transport validation, investigations, qualification, change control)?
- What is the current level of understanding and use of ICH guideline Q9 (R1) on quality risk management in active substance manufacturing?
- What would be the impact of the change resulting from ICH guideline Q9 (R1) on quality risk management?
The recommendations revisions are open for comments from stakeholders until 9 April.
