Bioequivalence and Bioavailability Forum • QA Training: SOPs, protocol

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

posted by chidambarajoshi – Hyderabad-INDIA, 2008-11-21 06:43 (6019 d 12:15 ago) – Posting: # 2757
Views: 19,843

Dear Shankar,

❝ we have to evolve day by day into a good system.

Yes..!
Training of not only QA but also clinical and Bioanaytical is QA's resposibility. This requires ofcourse management's support.
Or else also we can pick the technically sound guys and arrange for in-house training
According ISO a person working in the organization should undergo atlease 3 days/72 hrs of training in an year

❝ What are the crucial areas of BA activites that can be audited online to ensure quality of data produced?

It starts with

issuing of raw data forms for Bioanalytical/Clinical
In process audit of ongoing Method validation/Analysis according to Method validation protocol/Method SOP
Looking into the audit trail of batches (This needs Bioanalytical team's kind support )and QA can have it's own user ID and passwords to look into audit trail of the data
Auditing of raw data generated and looking into logbooks/other source data
Conducting internal facility audits (Weather are in alignment with SOP's or not if not again corrective actions)
Preventive actions to avoid reoccurrences of SOP deviations
Most important REPEAT ANALYSIS data (this needs in-depth Discussion)

Regards
Joshi

—
Best 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, protocolchidambarajoshi 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, protocol chidambarajoshi 2008-11-24 12:49
        LLOQ / Cmax Helmut 2008-11-24 12:54