Qualifications about of pharma equipments

Production
#1

Dear Sir
I have One doubt about of qualification.
Which Type of machines need DQ, FAT and SAT.

Actually, we have some solid mechanics commission completed without DQ how can I proceed IQ and OQ without DQ. Can I prepare in-house DQ is Accepted or Not sir if accepted I will approve DQ before SAT or Commission?

#2

Yes, you can complete the DQ of the equipment after commissioning. Don’t make a backdated document and do it on the current date.

#3

Which type of machines need FAT and SAT documents, sir.

#4

Generally manufacturing and engineering equipment.

#5

example: like Stainless Steel Reactors, Glass Lined Reactors,Agitator Nutsche Filters

#6

What is the critaria for requalification as per guidline?

#7

Dear member generally equipment’s defined as three types i.e.

  1. Ready available
  2. Configurable
  3. Customized

DQ Required for customized equipment’s only.

1 Like
#8

Hai

  1. Requalification shall be done when any major part changed in the equipment. And Guidelines also specified not clearly but it says for sold orals requalification shall be done 3-5 years. For parentals requalification shall be done yearly.
#9

nice topic for knowledge … i read all comments and happy to learn