IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE
FAILED THEN WHAT IS THE DESSICION U CAN TAKE
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Answer / k.g.gupta dr.reddy&
Phase I investigation should be done .
As a part of Investigation,Check the previous trend data and development of the product.Root cause is not identified then raise the OOS.
Second officer results also found OOS. We can conclude that the OOS results are due to the product behavior.
| Is This Answer Correct ? | 12 Yes | 2 No |
Answer / ramesh babu
First reject the product and raise the OOS.
| Is This Answer Correct ? | 11 Yes | 6 No |
Dear GUPTA, S2 AND S3 STAGE OF ANALYSIS WILL GENERALLY BE
DONE UPON THE FAILURE OF THE PRODUCT TO MEET S1 STAGE.HENCE
S2 OR S3 WILL GENERALLY BE PERFORMED THE NEXT DAY ,MAY BE
USING DIFFERENT LOT OF MEDIUM,APPARATUS ETC.HENCE THE REPEAT
ANALYSIS BY SECOND OFFICER DOES NOT ADD ANY VALUE .
| Is This Answer Correct ? | 4 Yes | 1 No |
Answer / senthilkumar
Product further investigate and if need re sampling once
again will do it through oos and do re analysis
| Is This Answer Correct ? | 7 Yes | 5 No |
Answer / m.praveen kumar
Reject that respective batch and no more for further
investigation
| Is This Answer Correct ? | 3 Yes | 1 No |
Answer / govindaraju
if s3 also faild , suppose that product is not packing
means we can reprossces that batch then we can go for s1
level and check the % of grug release
GOVINDARAJU .T DR.REDDYS
| Is This Answer Correct ? | 2 Yes | 1 No |
Answer / k.hemasundara rao
Whenever S1,S2 and S3 stages are failed investigate OOT of
the percular product by compared with already approved
batch. where as failed then investigate OOS of other than
laboratory i.e process oriented.
| Is This Answer Correct ? | 1 Yes | 0 No |
Answer / jagdish khamoriya
product desrroyed in batch and no further investigation to
QA department production and QC
| Is This Answer Correct ? | 0 Yes | 1 No |
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