14/15 July 2020
The ECA Validation Group was established with the goal to gather knowledge on validation, for example by continuously developing a Process Validation Good Practice Guide. The summary below will provide more details about recent and future activities.
ECA's 7th GMP Conference in Prague: Process Validation
At ECA's GMP Conference in Prague in May/June almost 50 delegates participated in a workshop on the EU Annex 15 enforcement and the Mutural Recognition Agreement (MRA) between the US FDA and EMA. The updated Annex 15 has been mandatory since 1. October 2015 and many European (and international) companies have not finished implementing it. Especially international companies with products on the US market have had challenges in the implementation since FDA's Process Validation Guide from 2011 is different in its wording, even though it is not in its principles.
ECA Qualification and Validation Task Team
ECA has established a "Qualification and Validation Task Team" within the validation group, which consist of both suppliers and pharmaceutical companies to enable a cost effective approach to qualification that supports the new Annex 15 as life-cycle activities, all the way from process development through commercial production and until a product is eventually discontinued. Now also equipment and manufacturing systems should be managed within a life cycle and can be more effective if the main suppliers understands the concept. The plan is to develope a Good Practice Guide that will be released in September 2018 at a conference focusing on cost-effective commissioning and qualification projects together with pharmaceutical suppliers, including equipment and system suppliers.
Ongoing Process Verification - the EMA perspective
One of the areas of the updated Annex 15 is the concept of Ongoing Process Verification (OPV) which is similar to FDA's Continued Process Verification (CPV) to ensure and document that manufacturing processes are maintained in a state of control throughout the commercial manufacturing.
There are significant differences in how companies implement their OPV programs and over the last couple of years the ECA course on OPV has shared some of these examples from companies with very good results. The feedback is that once an OPV program is established, it is not so difficult to maintain, although several find it difficult to integrate into other validation activities. A common challenge is how to link the OPV program with the Product Quality Review reporting. So over the next year we will focus on sharing examples of this within the Process Validation Group. If you have an example from your company, please share it with us and we will of course keep it neutral and confidential towards the group.
Process Validation - the impact of the MRA between FDA and EMA
Later this year it will become clear what the impact of the Mutual Recognition Agreement (MRA) between US FDA and EMA will be. Since the agreement was announced in March 2017 the work on the implementation has been ongoing and the impact should be clear no later than November 2017 when the first European countries are covered by the MRA. In practice it may mean that most European companies will just follow the principles of Annex 15, whereas global companies will use an approach that fulfills both FDA and EMA requirements.
FDA and the EU inspectorates will use inspection reports and other related information obtained during drug manufacturing facility inspections, to help determine whether a facility is manufacturing high quality drugs. It is therefore expected that there will be very few European FDA inspections, except in cases where additional information is considered necessary. So FDA or EU can require further inspections or take other action to protect the public.
Find out more about ECA´s Validation Group.