Out Of Specification (OOS)

GOOD DOCUMENTATION PRACTICE (GDocP) DEVIATION AND DISCREPANCY HANDLING
1

Can any one provide me the tree chart for OOS of dissolution, BU and related substances.

Please clarify the below points:

  1. How many number of replicates is required to prove the initial results failure? Is there any regulatory requirement for the minimum number of replicates?

  2. If my dissolution fails to meet the specification limits for 6 units (IR) whether i sholud log OOS abd proceed for S2 & S3 stage?

  3. For BU, if the initial first set (10 samples from different location) fails. How to proceed further? If I analyze the second set of 10 samples and meeting the specification limit is it ok for releasing the batch to next stage?

Regards,

C. Suresh

2

[quote=sureshmpharm]Can any one provide me the tree chart for OOS of dissolution, BU and related substances.

Please clarify the below points:

  1. How many number of replicates is required to prove the initial results failure? Is there any regulatory requirement for the minimum number of replicates?

  2. If my dissolution fails to meet the specification limits for 6 units (IR) whether i sholud log OOS abd proceed for S2 & S3 stage?

  3. For BU, if the initial first set (10 samples from different location) fails. How to proceed further? If I analyze the second set of 10 samples and meeting the specification limit is it ok for releasing the batch to next stage?

Regards,

C. Suresh[/quote]

Please do not asume that everyone here knows the abreviations you are using. Can you please clearify your abreviations that you are referring to? This will help understand your question and thus an answer will be provided much sooner than not at all.

3

Thanks for your suggestions.

Please find below the abbreviations used:

OOS —> Out Of Specification

BU ----> Blend Uniformity

IR —> Immediate release

S2 & S3 —> Different stages of dissolution as per USP.