Standard Operating Procedure For Quarentine Room Operation

by Pharmadocx Consultants

PURPOSE:

To lay down procedure for operating quarantine room.

RESPONSIBILITY:

Production Manager

PROCEDURE:

“ Quarentine room is a place where raw material, packing material, intermediate, bulk or finished products are isolated physically or by other effective means while a decision is awaited on their release rejection or reprocessing.”

Following items are stored in quarantine room           : –

1.     Empty ampoules / vials / plugs etc. issued for a batch waiting for their turn.

2.     Raw material issued is kept in quarantine room till batch is prepared.

3.     Goods to be subjected to leak test.

4.      ———– do———-   Visual inspection .

5.     Semi finished goods to be labeled or to be packed.

6.     Packed goods awaiting  release by Q.C. dept.

7.     Labels/Packing material issued for batch is kept in quarantine room until packing begins.

8.      Filled goods needing any sort of process are kept in quarantine room.

Author:
(GM Production)
Checked by:
(QA Manager)
Authorised by:
(Director Technical)
Date:Date:Date:

(Review date on or before 12 months from date of authorization)

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

10 June 2023

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