Covid-19

We are all impacted by the current Covid-19 pandemic. Everybody is asked to stay at home as much as possible and working from home as much as possible. Schools have been closed, but are now (in The Netherlands at least) slowly starting up. Also Svinx Consultancy has been impacted by this. My clients are asking me to work from home and audits are being postponed, due to travel limitations.

This gives a huge challenge for pharmaceutical companies, because how do you now qualify your contractors, as you are obliged to do as required by GMP. Of course you can send a simple questionnaire, but this will always show that each company has good procedures. How do you show that these procedures are indeed followed? Currently a lot of companies are using remote audits or virtual audits. Instead of only sending a questionnaire and reviewing the answers, you can dive a little bit more into the quality system.

A video conference is set-up, by which you can interview people. Furthermore, a shared cloud is used to share files that are being requested by the auditor. The competent authorities are currently using this type of inspections to extend or grant manufacturing licenses.

BioProcess online has publised a nice column last month about the pro’s and cons of this type of auditing. Although I do not agree to one of their pro’s: “Auditor can remain in pyjama’s” I do like the column.

I think that this type of auditing will become a standard method of auditing (as it also saves travel time)