Download pledge for stability study

Number:
Date:
Vice Executive President for Drug Sector
Subject: A pledge not to use Shipment of our agent/Company
………………….
Greetings,
Regarding our request No. ……, date …….., requesting the clearance for the
following product /products which has/have been exposed to high temperature
upon shipping:
Sr. Products Name Batch Number
Production date
expiration Date
Quantity
Which mentioned in the invoice No. ………, date …….. for the benefit of
………. And imported through airport/ custom …………………….
Accordingly, we commit to your Excellency not to use batch (batches) of the
above mentioned product (products) until the SFDA decision been issued in regard to
the stability study which submitted by the manufacturer to the Evaluation Department
at SFDA Drug Sector. And we Pledge to submit the stability study to the competent
department at the drug sector in maximum 21 working days, and if the SFDA Did not
Approve on the submitted stability study, or if the stability study has not been
submitted within the above mentioned period, the products mentioned above will not
be used, and will be seized, and the Regulatory procedures for the extermination will
be executed in the presence of a representative from Drug Sector, or the products will
be re-exported in accordance to the SFDA decision.
 The above mentioned products will be stored in accordance with
conditions of good storage and distribution practices in (our warehouse/
our agent/ our distributor) ……. In the city of ……..
Kind Regards,,,
Warehouse Manager of ……..