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.

(Aj) #5

Okay sir thank u will surely see it today

(Ajay A) #6

Most welcome you are…

(Sunil R. Budhkar) #7

Many thanks…