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1.6.1
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...
brunnerbalazs
Dec 1, 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...
brunnerbalazs
Nov 10, 20233 min read
Organization change - how to handle it in GxP environment?
Organization change is always fashionable. 'Let's start to centralize', 'Let's start to decentralize', 'Let's dedicate a team'. There may...
brunnerbalazs
Jul 3, 20231 min read
Change control vs Control on change - part 2: QC laboratories
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:...
brunnerbalazs
Jun 26, 20231 min read
Be brave! Kill your abandonded records!
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...
brunnerbalazs
Jun 15, 20231 min read
Change control vs Control on change part 1: general thoughts
Every pharma company has a well-established Change control system with the related system, SOP etc. But is that the best platform to...
brunnerbalazs
Jun 14, 20231 min read
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