PURPOSE:

To lay down procedure for visual inspection of parenteral products.

SCOPE:

This procedure applies for visual inspection of filled vials and ampoules.

 RESPONSIBILITY :

1. Production Manager

PROCEDURE:

INTRODUCTION :— Before packing each & every parenteral product undergoes strict naked eye visual inspection for the presence of any  particulate matter  and  other things  which can term them as rejected. Container is thoroughly checked  by keeping  in front of black & white   back ground and  gently  shacking . Put green slip in inspected goods, red slips in rejected goods & yellow slips in to be inspected goods.

Containers with following characters are rejected.

1.          Black/ white or any colour particle.

2.          Fibres.

3.          Crystals.

4.          Ampoules / vials with defective seals

5.          Cracked ampoules / vials

6.          Glass.

7.          Change in colour  of solution.

SUBJECT:      PROCEDURE FOR VISUAL INSPECTION OF FILLED VIALS AND AMPOULES.

8.          Volume less or more than  nominal volume .

9.             Deformed ampoule/ vial.

10.            Empty  ampoule/ vial.

11.            Any objectionable matter not described in the description of the product.  

12.            Coagulated powder in case of dry injections.

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