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.

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