by the preparation of this Reflection Paper to further discuss and agree practical interpretations that ensure appropriate visibility of product quality data with minimal duplication of effort between manufacturing sites, the QPs at these sites, Regulatory functions and the various legal entities that constitute the Authorisation Holder’ in order to find the best format for joint Product Quality ‘Marketing Reviews between all parties. For example, Chapter 1 requires a Product Quality Review (PQR) to take into account the ‘qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc.’ which is an aspect of the PQR which the MAH would not typically be equipped to assess. Conversely, the review of ‘Marketing Authorisation variations submitted, granted or refused’ is a key element of PQR which MAHs should be responsible for reviewing. Consistent interpretation across the EU of accountability of all parties involved in PQRs would be welcomed. It is noted that amongst the areas that are not considered to be well addressed at present are the provision of the necessary registered details, the management of MA variations, and regulatory commitments to manufacturing sites. Given the work currently being undertaken on ICH Q12 and the expectation that this will result in greater flexibility in post-approval lifecycle change management, it might be appropriate to include specialists undertaking EMA MAA assessments in the drafting group as well as GMP inspectors. Building upon the point above regarding Q12, and the increasing global collaboration amongst agencies on GMP (with e.g. the EU/US Mutual Recognition Agreement in progress) triggers the need for a robust and transparent EU inspection process with clear roles & responsibilities for all parties due to the major impact decisions on GMP status can have on global supply chains. Thus, the scope of the Reflection Paper should be expanded to include consideration of how the MAH can interact with the supervisory GMP authority inspecting the manufacturing site, specifically in the case of critical findings which might trigger a change in the GMP status of the supplying site.
by the preparation of this Reflection Paper to further discuss and agree practical interpretations that ensure appropriate visibility of product quality data with minimal duplication of effort between manufacturing sites, the QPs at these sites, Regulatory functions and the various legal entities that constitute the ‘Marketing Authorisation Holder’ in order to find the best format for joint Product Quality Reviews between all parties. For example, Chapter 1 requires a Product Quality Review (PQR) to take into account the ‘qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc.’ which is an aspect of the PQR which the MAH would not typically be equipped to assess. Conversely, the review of ‘Marketing Authorisation variations submitted, granted or refused’ is a key element of PQR which MAHs should be responsible for reviewing. Consistent interpretation across the EU of accountability of all parties involved in PQRs would be welcomed. It is noted that amongst the areas that are not considered to be well addressed at present are the provision of the necessary registered details, the management of MA variations, and regulatory commitments to manufacturing sites. Given the work currently being undertaken on ICH Q12 and the expectation that this will result in greater flexibility in post-approval lifecycle change management, it might be appropriate to include specialists undertaking EMA MAA assessments in the drafting group as well as GMP inspectors. Building upon the point above regarding Q12, and the increasing global collaboration amongst agencies on GMP (with e.g. the EU/US Mutual Recognition Agreement in progress) triggers the need for a robust and transparent EU inspection process with clear roles & responsibilities for all parties due to the major impact decisions on GMP status can have on global supply chains. Thus, the scope of the Reflection Paper should be expanded to include consideration of how the MAH can interact with the supervisory GMP authority inspecting the manufacturing site, specifically in the case of critical findings which might trigger a change in the GMP status of the supplying site.
efpia_comments_on_concept_paper_on_guidance_on_gmp_for_mah_final_20122016-1.docx