IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE FAILED THEN WHAT IS THE

Categories >> Sciences >> Chemistry >> Analytical Chemistry
Suggest New Category

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE
FAILED THEN WHAT IS THE DESSICION U CAN TAKE

Question Posted / ramireddy_bh

12 Answers
28105 Views
Cipla, I also Faced
E-Mail Answers

Answers were Sorted based on User's Feedback

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE FAILED THEN WHAT IS THE DESSICION U CAN TAK..

Answer / rc

Record an OOS and close it as product behaviour

Is This Answer Correct ?

19 Yes

2 No

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE FAILED THEN WHAT IS THE DESSICION U CAN TAK..

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

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE FAILED THEN WHAT IS THE DESSICION U CAN TAK..

Answer / ramesh babu

First reject the product and raise the OOS.

Is This Answer Correct ?

11 Yes

6 No

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE FAILED THEN WHAT IS THE DESSICION U CAN TAK..

Answer / rc

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

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE FAILED THEN WHAT IS THE DESSICION U CAN TAK..

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

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE FAILED THEN WHAT IS THE DESSICION U CAN TAK..

Answer / m.praveen kumar

Reject that respective batch and no more for further
investigation

Is This Answer Correct ?

3 Yes

1 No

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE FAILED THEN WHAT IS THE DESSICION U CAN TAK..

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

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE FAILED THEN WHAT IS THE DESSICION U CAN TAK..

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

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE FAILED THEN WHAT IS THE DESSICION U CAN TAK..

Answer / rc

Gupta, WHEN PRODUCT IS NOT MEETING THE SPECIFICATION UPON
TESTING OF 24 UNITS ,IS IT REALLY REQUIRED TO CARRY OUT
ANALYSIS BY SECOND OFFICER?

Is This Answer Correct ?

2 Yes

3 No

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE FAILED THEN WHAT IS THE DESSICION U CAN TAK..

Answer / jagdish khamoriya

product desrroyed in batch and no further investigation to
QA department production and QC