24/25 May 2022
With the revision of Annex 15 in October 2015 new equipment qualification steps are mentioned - Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) as a “may-option”. But in fact these two activities are often used to reduce the qualification workload. This concept is also mentioned in different guidelines, e.g in ECA`s Integrated Qualification and Validation Guideline, which describes a strong partnership between suppliers and customers to receive a GMP compliant but also streamlined equipment qualification result.
However, due to the Covid-19 pandemic personal presence of pharmaceutical customers at the supplier site has generally been reduced or even become impossible - especially for FAT. So “remote-FATs” came up more and more in the last year and are still used. But how successful are such remote FATs? What are the problems showing up? This was something we wanted to find out from you, to get an overview - and therefore a survey was set up, comprising seven questions. A total of 140 took part in the survey. In the following, you will find an extract of the questions asked and their answers. Not all participants answered all questions, and sometimes several answers were given, so that, in some cases, the percentages add up to more than 100%.
The majority of 82 participants come from the pharmaceutical industry (over 60%), almost 15% from the active substance producing industry (chemical and biological active substances) and 6% are equipment manufacturers as well as 3% are manufacturing medical devices.
31 (39 % ) participants are involved in validation/qualification activities, 17 (21 %) participants are from a "Q-department" (QM, QA, QC). Five are consultants, also five respondents work in a technical department (6 % each) and another five are CEOs/Managing Directors.
Almost 45 % of 83 participants come from companies with more than 500 employees, just over 30% are employed in companies with 100-500 employees. The remaining participants are divided between companies with 1-50 (8%) and 50-100 (15%) employees.
The first question was: "Are you using remote FATs? 56% of the 140 participants answered yes, corresponding to 44% not using remote FATs. Those answering that they do not use FATs were also asked "Why not?" The answers (32 participants) were heterogeneous, but some answers can be clustered. Seven participants answerd FAT was not necessary (e.g. only small equipment was qualified), another four participants said FAT on-site was still possible and six participants thought that on-site is more helpfull and a FAT without seeing and touching the machine wouldn´t work. Other answers were e.g. no procedure available, don´t know how, etc.
To the question "How many remote FATs have you conducted?" we received 75 answers, 21% out of which conducted one remote FAT, 51% 1-3 and 28% conducted more than three remote FATs.
Asked to rate remote FATs (excellent, good, average, fair, poor ). 31 participants (44%) rated them average, 24 (31%) good, nine (13%) poor and six (8%) fair.One out of those answering to the question (71 persons) rated remote FATs as excellent.
What are the "pros" of remote FATs? This question answered 51 participants. The most frequent argument for remote FATs was reduced (travel) time (26 answers, 51%). 17 participants (33%) like the cost reductions. Also mentioned was higher/greater flexibility (eight participants, 16%), more people, e.g. SMEs, can participate (six participants, 12%) and less contacts/don´t get sick (three participants, 6%). Two respondents appreciate the reduced workload in comparison to on-site.
On the other hand we asked where do you see the con´s of a remote FAT? 52 participants answered. 14 (27%) are missing the hands-on experience at the machine at the supplier's site. Ten participants (20%) stated that the relationship between supplier and customer suffers. Can´t see enough details was mentioned eight times (15%). Four participants each mentioned that internet connection caused problems, the documentation review would be difficult and the big picture is lost and deficiencies could have an impact on qualification. Also three participants (6%) argued that FATs require to trust the supplier and that it is rather not possible for complex machines.
We also wanted to know what the preconditions are that must be fulfilled to concuct a remote FAT successfully. 48 participants answered. Nine of them (19%) mentioned a detailed FAT protocol plan, eight participants (17%) recommended that the remote FAT should be planned/organised with guidelines, agendas, agreements. Also eight participants saw multiple cameras with different angles as necessary. Three of those answering recommended good internet connectivity, good video technique and agreements how to handle electronic signatures. Two participates wanted to have a share point to share files/folders - and the machine shoud be ready/built.
Finally we wanted to know wether respondends will continue to use remote FATs also after the Corona pandemic? - which 26 (56%) answered with Yes, 21 (44%) with No.
Conclusion: Remote FATs are widespread today. Over 50% of the participants conducted 1-3 remote FATs and even 28% more than three. On the other hand 40% of the respondends are not conducting remote FATs. Why not? They argued among other things that FAT was not necessary (e.g. only small equipment was qualified) and six participants still prefer on-site FATs. The biggest advantages for remote FATs are seen in the cost reduction and the travel (time) reduction. The biggest disadvantages are that during an on-site FAT the hands-on experience is lost. Preconditions for remote successful FATs in the respondents´ view are detailed FAT protocols/plans and a clear planning .
At this year's ECA Launch Conference on 16/ 17 November 2021 online the version 2.0 of the Good Practice Guide Integrated Qualification and Validation will be presented. This new version comprises a subchapter about remote FATs/SATs and an appendix with a checklist for remote activities as well as tips and tricks.