As the title suggests, when or what must be considered to understand if one or more IPCs can replace a concurrent PV, after a change/project for...
A year late but thanks :)
Hi guys, as a title I would like some advice on possible books to buy about process validation in the pharmaceutical field. Thanks
Are there opinions? Anyone?
Hi, have anyone "the Parenteral Drug Association (2013) - Technical Report No. 60 - Process Validation: A Lifecycle Approach" to share, please? It...
Hi, I've a question: Is it correct when I say that during an OQ protocol must be tested all the CPPs and their ranges? Thanks. Pharma GMP Annex...
Thanks Bev D. Are there other books, articles or web sites to increase my knowledge regarding the data interpretation or which you or the other...
Hi everyone, I need some information. Is there a book that allows me to better understand how to interpret control charts X – R, X – S, etc.? All...
Ok, thank you very much
CPP = Critical process PARAMETERs
Perfect but practically talking, the edge of failure is a range of numbers, a tolerance of the input setting. Input settings = CMA (Critical...
Yes, sorry my mistake with the translation. I meant Edge of Failure. Could you be a little clearer? I can't understand what you mean.
? OK ... QbD = Quality by Design CQA = Critical Quality Attribute QTPP = Quality Target Product Profile DoE = Design of Experiment
Hi, I've just started to study the QbD, so what I understand is that the QTPP is what matters to the actual user including the doctors and the...
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