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Handling of Returned Drug Products

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47 views2 pages

Handling of Returned Drug Products

Uploaded by

Sanjay yadav
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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LOMUS Standard Operating Page No.

: 1 of 2

Pharmaceuticals
Pvt. Ltd.
Procedure SOP No. : LPPL/P/S/404
Gothatar, Ktm; TITLE : HANDLING OF RETURNED
Supersedes No. : New
Nepal DRUG PRODUCTS

Prepared by : Checked by : Approved by : Effective Date : 01.01.2007


Date : Date : Date : Review Date : 01.01.2009

1. Objective: To lay down Procedure for handling of returned drug product.

2. Responsibility: Warehouse & Quality Control.

3. Accountability: Quality Assurance.

4. Procedure:
a. Returned product is a drug product which is retuned to the factory due to
complain of technical quality defect, or in adverse drug reaction, expiration or
wrong delivery.
b. Drugs product could be returned only after an approval from the marketing
department is obtained and should be accompanied with a delivery note from the
distributor.
c. Warehouse department receives and inspects the returned drug product, and
records the product name, batch no., expiry date(if any), quantity and package
form.
d. The warehouse department places the returned drug product in the quarantine
area.
e. Warehouse Department issues a receiving note and send it to the Quality Control
Department.
f. Quality Control Department takes samples of the returned drug product.
g. During sampling inspection is made of the integrity of the packing and product’s
appearance. Note down the packing conditions e.g.:
i. torn or damaged
ii. dirty
iii. missing label
iv. integrity of the seal
LOMUS Standard Operating Page No. : 2 of 2

Pharmaceuticals
Pvt. Ltd.
Procedure SOP No. : LPPL/P/S/404
Gothatar, Ktm; TITLE : HANDLING OF RETURNED
Supersedes No. : New
Nepal DRUG PRODUCTS

Prepared by : Checked by : Approved by : Effective Date:01.01.2007


Date : Date : Date : Review Date : 01.01.2009

h. Returned drug product with the following conditions must immediately be


rejected:
i. damaged or partly damaged
ii. damaged primary packing
iii. expired
iv. traces of damage due to fire of flood
i. If necessary the Quality Control Department investigates and performs test
whether the drug product still meets its specification.
j. Based on the investigation and test results Quality Control Department will decide
whether the returned drug product could be.
i. returned to stock;
ii. redressed;
iii. reprocessed; or
iv. rejected.
k. If the returned drug product is rejected, it must be clearly identified as such. Its
destruction must be schedules and documented.
l. If the returned product is reprocessed of redressed, the production Planning and
the Production Department are to be informed to schedule for the reprocessing
and repacking process.
m. The redressed drug product must be identified by adding of suffix “R” to the
batch number. The reprocessed drug product must be identified with a new batch
number.

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