Shaigan Pharmaceuticals (Pvt) Ltd.

Manufacturing Procedure Ceftiz 250 Dry SOP #. PR/ SP MP 007

Powder

Prepared by: Production Pharmacist Effective Date:10-02-06

Approved by: Production Manager Rev.#: 00

Rev Date:
Page 1 of 2
Reference: SPL Std.

Purpose

To Fill Ceftiz 250.

Responsibilities
Production pharmacist

Procedure
1-Filling
It is ready to fill powder

Before starting filling operation expose the powder container in transfer hatch for

half an hour under UV lights. Then spray the surface of the container and critical

parts of the filling machine with 70 % IPA. Open the powder container and

transfer the powder in the hopper by using the sterilized scoop. Then adjust the

weight of the powder as per specification given by quality control

Check the weight of the powder after every 15 minutes

3-OPTICAL CHECKING
Check the filled vials as per procedure of optical checking

2- Packing
After getting line clearance \sterility report from micro quality assurance, label the
vials by labeling machine. Then vials are packed in printed unit cartons, which
are duly imprinted with batch No Mfg.date Maximum Retail Price. Finally transfer
the finished packs in master cartons and label them properly
 Shaigan Pharmaceuticals (Pvt) Ltd.

NOTE
Before starting the manufacturing \or filling process, get the area clearance report
from Quality assurance\ micro lab then proceed further

Record
BMMF, & all record generated during processing of batch.