OOS- Out of Specification Investigation – Interview Question and Answer

Do we need to raise an OOS, if OOS result is observed during API Method transfer

First defined which lab mean by

• • At receiving lab
  • At originating lab

YES Required

• Caution: inform API vendor about failure
• Investigation release analysis
• Assess impact on DP(drug product) where said API is used

At receiving lab

No Required

Investigation can be carried out through lab incident to identify root cause

Do we need to raise an OOS, if OOS result is observed for vender evolution API sample ?

NO

Just vender qualified so not much resk

• Investigated lab incident
• Communicate to vender if no lab error observed

Do we need to raise OOS if OOS result is reported, where bracketing std is failed?

No

          Bkt fail in such case that system have some error hence go on further as incident or deviation through investigation

Do need to raise an oos result is observed for swab / residue analysis ?

Yes

Do we need to rauise an OOS, If API result is OOS during working std qualification?

• • If API used only for WS qualification for WRS qualification
  • API lot is used for MFG of Drug product

-if  API use only for WRS qualification

NO

• Investigation through lab incident
• Caution: inform API vender about failure
• -API lot is used for MFG of Drug product

YES

• Caution : inform API vendor about failure
• Investigate release analysis
• Assess impact on Drug product where said API is used

6. If OOS result is found during OOT or incident investigation Do we need to raise an OOS

• If hypothesis is just as per stp (test procedure )

Yes OOS to be taken

• Ideally, hypothesis should not be exactly as per STP.
• If u follow same test procedure as a hypothesis indicates you follow same procedure as a hypothesis : indicates you are trying to check whether sample is meet specification
• If  hypothesis is not as per stp (test procedure )

NO, OOS need not be taken

Hypothesis testing must not be exact as per stp hypothesis testing may be with certain modification in procedure During hypothesis testing root cause is not yet clear and hence reported result (pass/ fail ) may attributed to testing error.

As we are sure about report value (confirm pass / fail) result reported during hypothesis testing may be true or valid

 

Example: exact method say crush tablet into fine powder hypothesis : crush tablet into coarser powder (to prove non-homogeneous sample into OOT)

[not all are experiences, knowledge base, internet, youtube base content taken  ]