One of the easiest and quickest risk assessment tools is the classification of deviations through Risk Priority Number (RPN) calculation....

In part 1, we discussed when it is worth to open CAPAs. In Part 2, we discuss how we can establish a good quality CAPA. Now, let's see...

Organization change is always fashionable. 'Let's start to centralize', 'Let's start to decentralize', 'Let's dedicate a team'. There may...

In part 1, we discussed when it is worth to open CAPAs. Now, let's evaluate what we need to think through when we define the CAPA itself....

Even in 2023, the digitization is not fully implemented in every company. What is the result of this? You still need to maintain...

CAPA is basic process in all pharma companies, being not only a mandatory one, but can (should, must) be also an asset in continuous...

Let's collect all requirements on training from GMP. EU GMP Volume 4 Chapter 2 Section 2: Training '2.10 The manufacturer should provide...

Introduction Okay. So this is going to be interesting. A really fashionable and fascinating topic, but also kind of sensitive. For this...

In part 1, I cautiously questioned that the big-guy change control system should be used for every change. Let me give an example area:...

You may fall into an OOS investigation, when even after a thourough expedition, you have doubts if your lab does something wrong, or you...

The emphasis is on the QC - as I see, there is a difference between a good analytical method and a good QC method. Introduction One...

EU GMP Volume 4 Annex 15 clearly describes the need for design qualification activities. Let me cite the requirement from section 3.1:...

There seems to be some work on updating EU GMP Volume 4, Annex 11. I'm looking forward to it! But even in the current version we can read...

Just a quick thought here. Risk management, compiling risk assessments are with us for a while now. The first version of ICH Q9 was...

Another term that cannot be found in regulations or guidelines: orphan data. How can we define it, and what requirement should be...

In some ways, almost everybody met the term 'master data' (only for my Hungarian fellows: törzsadat :) ). It's used not exclusively in...

The draft version of ICH Q2 sees roboustness as not a validation element, but a step of development. Reading that brought back some...

There are several trainings and fancy tools out there on different risk assessment methods. But there are also good materials on ICH...

We discussed in details how can we establish a well-operating OOT-limit for our products. But what can you do when you have a result you...

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