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1.6.1
brunnerbalazs
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...
10 views0 comments
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...
6 views0 comments
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...
10 views0 comments
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:...
63 views0 comments
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...
27 views1 comment
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...
21 views0 comments
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...
2 views0 comments
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...
10 views0 comments
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...
14 views0 comments
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...
7 views0 comments
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...
4 views0 comments
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...
4 views0 comments
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....
4 views0 comments
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...
5 views0 comments
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...
1 view0 comments
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...
12 views0 comments
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...
4 views0 comments
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...
11 views0 comments
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