ECA Validation Group: Survey Results

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

The ECA Validation Group which currently counts 193 members is one of ECA's seven Working/ Interest Groups. We've asked the members of the Validation Group about their topics of interest and in which direction the group should evolve.

In total, 84 participants answered the survey. Yet, not every question has been answered to by all the participants. 72.5% of the respondents work for international companies, 17.5% in national companies and 10% have a field of activity in Europe. For 68%, the centre of interest strongly focuses on the EU, 38% are particularly interested in the FDA. Half of the responses came from companies with less than 100 employees, 29.7% of the responses came from persons who work in companies with up to 500 employees and 20.3% of the participants work at large companies (> 500 employees). The production range of the companies at which the participants are employed mainly concerns finished products (59%), and then biologics with 19.2%, and 11.5% manufacture APIs. Another 10.3% are employed in distribution. Regarding the horizon of experience, the participants are mainly highly experienced. 68.3% of them have more than 3 years of practical experience in their current field of activity. No fewer than 20.7% have close to 3 years experience and 11% of the respondents have been already working for at least one year. For the majority (43%), Qualification/Validation is one activity amongst others. 27.8% of the participants occupy 50% of their daily working time with the topic Qualification/Validation and 29.1% operate Validation/Qualification more than 50% of their daily working time.

Now, about the survey itself. The interest frontrunner is Process Validation, followed by Cleaning Validation and Requalification on third place. It is interesting to note a still high medium interest for the qualification of delivery systems (see illustration 1).

Illustration 1 - Overview of the ECA Validation Group members' centres of interest, as of July 2016

Only a few further comments have been made. An accumulation of topics couldn't be observed in the comments. Only the topic Computer Validation was mentioned twice. Yet, ECA has an own IT Compliance Group. Apart from that, the following topics were named: On-going Process Verification, Cleaning Validation in "shared facilities", Change Control during Qualification/Commissioning, Lean Qualification, Data Integrity factors, Equipment Qualification vs. Computer Validation, Risk Analysis, Periodic Review of the validation status, validation level at suppliers.

In the survey, the question was also asked in which direction the group should evolve (Business Plan). Here again, there was no clearly similar answers. Two participants wish current GMP-related topics, whereby one of the answers stated "what the ECA already offers". Besides, the following preferred topics were mentioned: Statistical Evaluations, Sample Plans, Knowledge Management, Cleaning Validation for the manufacture of veterinary medicinal products, Assessment of the current Developments in industrial Process Validation (classical validation vs. hybrid vs. continuous), Interaction between On-going Process Verification and PQR, Process Validation in the area of biologics, Modern Cleaning Validation.

Conclusion
For the ECA Validation Group members who participated in the survey, their centres of interest are:  Process Validation, Cleaning Validation and Requalification. Particularly interesting are (also) future current GMP topics in the area Validation/Qualification.

To satisfy those wishes, the ECA is organising an Annex 15 Conference on 23/24 February 2017 in Hamburg, Germany. At this conference, case studies will present the current industrial implementation of

• Lean Qualification
• Continuous Process Verification 
• On-going Process Verification
• Transport Verification
• Packaging Validation
• Cleaning Validation - PDE concept

Are you interested in Qualification/Validation? Become a member of ECA's Validation Group. The membership is free of charge and in addition you will have the opportunity to download ECA´s Good Practice Guide on Validation.  Over 174 pages, the guide describes "what has to be done" and shows "how" with regard to the modern requirements in the area of validation according to Annex 15 and FDA's Process Validation Guideline.