Production equipment and process


(Aj) #1

May I know from where I get stuffs related production equipment and process to read and learn as a QA person.


(Sunil R. Budhkar) #2

You can get details of manufacturing equipment from the operating manuals and drawings provided by the equipment manufacturer or fabricator. For understanding processes you can read the R & D product development reports or product development data from R&D. Also, read GMP guidelines of different Regulatory authorities to corelate manufacturing equipment, processes and GMP requirements.


(Aj) #3

Okay thank u


(Ajay A) #4

You need to see the guidelines like 21cfr 211,WHO TRS 961 annexures and EU volume 4.
These are all having good information regarding the equipment and process related GMP.
Tq


(Aj) #5

Okay sir thank u will surely see it today


(Ajay A) #6

Most welcome you are…


(Sunil R. Budhkar) #7

Many thanks…