Last week’s round -up;
02-06 August 2021

Follow-up Survey of QPs on Remote Certification

In March 2020, the European Qualified Persons Association (EQPA) carried out a survey amongst its members on the topic of “Remote QP Certification”, which was perceived as an area of non-harmonized national interpretations. The EQPA sought to better understand the differences across the EU/EEA and on how QPs positioned themselves in such a procedure. One year later, in March 2021, the EQPA carried out another follow-up survey on the topic as it is “in the interests of all QPs” to review how this difficult period is being managed today. The follow-up survey contained similar questions to the first survey and more than 300 QPs took part. The pattern of answers “reinforces what was seen in March 2020 but with greater use of remote certification and more developed procedures generally. That may not necessarily be true with respect to the personal experience of each individual QP”. The survey also showed that “while many QPs made obvious progress to stabilize their certification processes in light of the pandemic, some gaps remain and should be closed”.

A detailed discussion of the results of the follow-up survey may be found in the following article: https://bit.ly/RealCMC-2WSnsX0

EMA News: Six month count-down to CTIS system go live

As set out in the Clinical Trials Regulation, the entry into application of that Regulation is set by the publication of a notice in the Official Journal of the European Union, which confirms that the clinical trial EU Portal and Database, one of the main deliverables of the Regulation and the key component of CTIS, has reached full functionality. The application of the Regulation and the go-live of CTIS take place six months after the publication of this notice. The EC has confirmed that the entry into application of the Clinical Trials Regulation and hence the go-live date for the Clinical Trials Information System (CTIS) will be on 31 January 2022.

Full details of the confirmation can be found here: https://bit.ly/RRL-3yyfJvi

New PIC/S guidance on PQS risk-based change management and COVID-19 risk assessments

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has adopted two new guidance documents on the effectiveness of pharmaceutical quality systems (PQS) and COVID-19 risk assessment for on-site inspections. The updated guideline “How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management”, includes a “checklist of lifecycle factors where inspectors should expect change to occur, which includes the introduction of new products, upgrades, changes in materials, test method changes, improvements in manufacturing processes and capacity, quality issue corrections, regulatory changes, improvement initiatives, and addressing PQS signals”. The COVID-19 risk assessment guideline for on-site GxP inspections provides recommendations for the risk assessment which should be performed during the inspection planning phase together with the site prior to the actual inspection.

https://bit.ly/RealCMC-3ipg1yT

HMA CTFG Date for last receipt of submissions for the VHP prodedure

HMA’s CTFG has announced that the date for last submission of a VHP application is 15th Oct 2021, in order that all procedures will have resolved in Jan 2022. This is to ensure a smooth transition to the full implementation of the CTR 536/2014 which is planned for the 31 January 2022; full details can be found here: https://bit.ly/RRL-3C6Ubbb