Qualifications about of pharma equipments

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?

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

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

Generally manufacturing and engineering equipment.

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

What is the critaria for requalification as per guidline?

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

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.

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