Bioequivalence and Bioavailability Forum

QA Training: SOPs, protocol [GxP / QC / QA]

posted by chidambarajoshi – Hyderabad-INDIA, 2008-11-24 13:49 (6419 d 22:07 ago) – Posting: # 2786
Views: 25,220

Dear shankar

❝ I could not find in guidelines the criterial for selecting LLOQ.

Yes..! 1/20 of Cmax is usually followed

❝ I found that persons from GMP back grownd (staff or sponsors) tend to involve QA more into the activites. One can feel it while facing sponsor and third party audits. Your comments please

Yes..! This is what I mean in my previous answer. At the time of audit Sponsor/third party though respective departmental Group leaders respond for queries it's ultimately responsibility of QA whole. So though we are QA we shall not limit ourselves to QA only. Involve in every activity (Can be off Training SOP) then QA will be the master and dependable.
For ex: If QA is reviewing the calibration document of LC-MS/MS it's not possible to understand without the basic knowledge of LC-MS/MS. So train the QA guys to the core to handle all the situations

Regards,
Joshi

Complete thread:

• QA Training vish14184 2008-11-15 09:35 
  • QA Training: SOPs, protocol Ohlbe 2008-11-15 13:16
    • QA Training: SOPs, protocol chidambarajoshi 2008-11-17 11:08
      • QA Training: SOPs, protocol vish14184 2008-11-18 09:12
        • QA Training: SOPs, protocol mbshankar 2008-11-18 11:31
          • QA Training: SOPs, protocol chidambarajoshi 2008-11-18 12:00
            • QA Training: SOPs, protocol mbshankar 2008-11-18 12:43
              • QA Training: SOPs, protocol chiragkhatri 2008-11-19 05:56
                • QA Training: SOPs, protocol chidambarajoshi 2008-11-19 07:28
                  • QA Training: SOPs, protocol mbshankar 2008-11-19 10:43
                    • QA Training: SOPs, protocol chidambarajoshi 2008-11-19 11:45
                    • QA Training: SOPs, protocol chidambarajoshi 2008-11-19 11:47
                      • QA Training: SOPs, protocol mbshankar 2008-11-20 06:46
                        • QA Training: SOPs, protocol vish14184 2008-11-20 09:37
                        • QA Training: SOPs, protocol chidambarajoshi 2008-11-21 05:43
                          • QA Training: SOPs, protocol mbshankar 2008-11-22 05:09
                            • QA Training: SOPs, protocol chidambarajoshi 2008-11-24 11:22
                              • QA Training: SOPs, protocol mbshankar 2008-11-24 12:22
                                • QA Training: SOPs, protocol Ohlbe 2008-11-24 12:41
                                • QA Training: SOPs, protocolchidambarajoshi 2008-11-24 12:49
                                • LLOQ / Cmax Helmut 2008-11-24 12:54