Out of specification Investigation Step in pharmaceutical

Scope

• • 1. Input Martial
    2. In process stage
    3. Finish product
    4. Stability

Note : Not applied in process stage which give procedure Further operation (e.g like give option in BMR if result not found as per Limit and further go operation e.g CF drying sample)

Purpose:

Ensure that product safe

Find the root case of OOS

Minimize the reoccurrence of Lab error

Avoid testing in compliance

Evaluate the impact of OOS on another Batch.

Analyst shall report OOS result to supervisor

All the dilutions, reagents and glassware used shall be reserved till completion of lab investigation

Calculations shall be verified

Check for obvious instrument failure.

Look for obvious error

Investigation flow

Phase 1A:(Lab obvious Error)

Phase 1B:(Lab investigation

Phase 2 :(Manufacturing and Lab investigation)

Phase 3 : Investigation

Phase 1A:(Lab obvious Error)

• • • Sample spillage
    • Power failure
    • Incorrect sequence and vial placement
    • Equipment failure (Leakage, pressure drop, Bubble, back pressure)
    • Incorrect process parameter

    • Evidence of above parameter to be enclosed with report

Phase 1B:(Lab investigation)

• • • Discuss the method with analyst for possible error
    • Verify validity of test method
    • Correctness of sample, storage condition and sample handling
    • Sampling procedure, probability of sample contamination
    • Analyst qualification
    • Correct dilutions and weighment of sample
    • Column correctness, filter accuracy

Note: check pipett use for dilution, flask

Some time may be use the 10 ml  volumetry flask instead of 5 ml

Column correctness: historically column use or different column use of particular analysis part number make etc correct

 

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