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Dec 5, 20232 min read

Chromatographic columns and their qualifications

We have mentioned earlier the importance of choosing and testing of the column when developing a chromatographic method. But what should...

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brunnerbalazs

Dec 1, 20233 min read

Extension - what is the key to do it in a compliant way?

I'm sure you need to work with deadlines. 30 days' lead-time for deviation or complaint investigation, also hard deadlines for CAPAs and...

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brunnerbalazs

Nov 24, 20232 min read

Deviation management - how to capture our event the best way?

Several different guidelines, laws are mentioning requirements about deviation management, but mostly about the essence of...

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brunnerbalazs

Nov 13, 20232 min read

Periodic reviews - what to use them for?

PQR, QMR, CPV, VMP/VMR, Computerized systems' periodic reviews, who knows what else...we manufacture these summaries, but exactly what...

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brunnerbalazs

Nov 12, 20232 min read

Retest period or shelf-life?

I just received a question that looked easy at first, but the laws and guidelines are surprisingly vague on this topic. The question is:...

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brunnerbalazs

Nov 10, 20233 min read

Document types: differences and consequences (part 1?) - specifications and procedures

Since documentation is one of the cornerstones of Pharmaceutical Quality Systems, EU GMP Volume 4 dedicates a full chapter (Chapter 4) in...

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brunnerbalazs

Nov 10, 20233 min read

API reprocess and rework - how can we save a batch?

When an API batch is OOS, several processes get initiated in parallel. We need to exclude the possibility of any lab errors (OK, this is...

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brunnerbalazs

Sep 19, 20234 min read

Self-inspection vs internal audit

In big pharma, there are usually two levels of 'periodic self-check': self-inspection and internal audit. But what is the real difference...

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brunnerbalazs

Sep 12, 20232 min read

Business Continuity Plan - theory and practice

What is Business Continuity Plan? Before starting to think about Business Continuity Plan for computerized systems, let's clarify the...

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brunnerbalazs

Sep 11, 20232 min read

URS in AIQ - how to specify an analytical instrument?

We have covered several parts of the AIQ: a promotion for a couple of fine white papers, DQ, and PQ. Now let's start to think about how...

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brunnerbalazs

Sep 11, 20231 min read

Key responsibles

In big pharma, it's usually easy to separate the different responsibilities: you have a lot of people in big organization charts to show...

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brunnerbalazs

Aug 9, 20232 min read

What is master data? - part 2: a simple example

-------------- In a previous post, we tried to define master data, and collect the requirements to it. Now let's try to go through some...

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brunnerbalazs

Jul 29, 20231 min read

Deviations during requalification

There was a post earlier about how to manage OOC investigations. But what if your service provider has its own deviation management...

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brunnerbalazs

Jul 28, 20232 min read

OOC/OOA - how to handle it?

In case of analytical instruments, some companies use the term Out-Of-Calibration, others use Out-Of-Acceptance for failed recalibration...

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brunnerbalazs

Jul 28, 20232 min read

Retest - when you need the most, but how?

Okay, here's a situation: you did your QC-test*, and the result is OOS out of the blue- but you know, you really know it is a lab error....

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brunnerbalazs

Jul 25, 20234 min read

(Not so) quick thought about GC method development

Let me think out loud about how to develop the perfect GC method for QC purposes. In pharma, there may be a lot of different GC-methods...

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brunnerbalazs

Jul 25, 20232 min read

AIQ - how about the IQ?

In former posts, we discussed the DQ in general, and the analytical instrument PQ. Now let's collect what we need to perform a thourough...

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brunnerbalazs

Jul 20, 20233 min read

Any clue on validation of a glassware washing machine?

Every company comes up with an approach how to handle glassware washing machine qualification. If it's a new company, somebody definitely...

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brunnerbalazs

Jul 14, 20233 min read

Audit trail review - how to do it properly?

Related to the data integrity fashion-wave, the audit trail review, as a process receives high attention. It's obvious that 'the' audit...

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brunnerbalazs

Jul 13, 20232 min read

AIQ - what should PQ contain?

Sometimes the question comes up: what should we really test during the PQ on a newly purchased analytical instrument? You did your best...

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