In the first part, after the introduction we discussed mostly where we should look around searching for OOT-limits. This second part is...

Disclamer: this and the following posts are only about the release test related OOTs, the stability OOT-limits are not considered. I...

The new version of ICH Q9: Quality Risk Management is going to be implemented in EU in 2023-JUL-23. This version doesn't contain any big...

Sometimes these two terms are mixed up. But is there any real difference? Let me quickly say a big 'Yes' here. What does FDA say (21 CFR...

It's easy to decide if something is to be handled as a computerized system, or 'only' an instrument - most times. What is at stake here?...

Even the best companies might face the situation that an old unclosed event fall out of the closet. It can be a two-year old CAPA, a...

I received the question several times if it is a compliance issue to leave empty fields in electronic record. Let me just copy-paste my...

Every pharma company has a well-established Change control system with the related system, SOP etc. But is that the best platform to...

Agilent tries to help the companies understand the essence of the latest (2017) change in USP section <1058>: Analytical Instrument...