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DQ, IQ, OQ and PQ for machines (Centrifuges, reactors...)

DQ, IQ, OQ and PQ for machines (Centrifuges, reactors...)

(OP)
Dears colleages,

Where I can find the steps and protocols about Validations documents for pharmaceutical machines(DQ, IQ, OQ and PQ).

Do you have any example?

Thank you for advance
Jordi Beltran

RE: DQ, IQ, OQ and PQ for machines (Centrifuges, reactors...)

Are you still looking for information in this area?  I work for a pharmaceutical company and am very familiar with these types of documents.

RE: DQ, IQ, OQ and PQ for machines (Centrifuges, reactors...)

(OP)
Hello,

Thank you for your response.
I still find this information. I use a Draft API GMP Guide "Internationally Harmonised Guide for Active Pharmaceutical Ingredients", but is only theoretical.
I Know the concepts about (DQ, IQ, OQ, PQ, FAT & SAT)but I don't Know as I can write a protocol.

Dou you have any example?

Thank you for advance.

Jordi Beltran

RE: DQ, IQ, OQ and PQ for machines (Centrifuges, reactors...)

send me an e-mail to chixon@i d e c p h a r m.c o m

...remove spaces.

I will send you some examples.  Let me know what kind of equipment you are looking to qualify.

Carl

RE: DQ, IQ, OQ and PQ for machines (Centrifuges, reactors...)

A good website for design type documentation is http://www.jettconsortium.com

covers VP, URS, FDS, DS's for the regulated industry.

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