ANNEXURE-V QUALITY

CONTROL
Title: Stability Study Protocol

Product name

Specification No.

Primary packing
material description

Source of API

Claimed storage
Condition

Shelf life (months)

To evaluate the stability and shelf life of finished product in market pack
Purpose
at claimed storage condition.

 Change in primary
Reason for study  New product  change in process
packing material
(tick-mark whichever is
applicable)  change storage
 change in key RM  Reprocessed product
conditions.
 Routine stability  Other (specify):
Stability Storage
 40±2°C, 75±5%RH  25±2°C, 60±5%RH
Condition (tick-mark
whichever is
applicable)  Other (specify):
Batches to be studied
(tick-mark whichever is  One  Two  Three
applicable)*
- QC officer/executive: Protocol/Report preparation, Sample load-
ing/ unloading, Testing and analytical report preparation
- QA Executive or designee collects the required number of samples
Responsibility
from Production
- QC executive Protocol/ Report review
- QC head/ Manager: Protocol/ Report approval
Prepared by /date Approved by / date
Protocol Approval Checked by / date (QC)
(QC) (QC)

Prepared by/Date Checked by/Date Approved by/Date

Format Number: QC 047-F5-00-New Page No.: 1 of 1