DELTA PHARMA LTD

Pakundia, Kishoreganj.

STANDARD OPERATING PROCEDURE

Issue No : 1/4 Issue Date : 1st April, 2004 Revised Date : September-2006

Written By : Approved By :
Name : Md. Mahbubur Rahman Name : Md. Ataur Rahman
Designation: Quality Assurance Officer Designation : QC Manager
TITLE : SOP FOR SAMPLING AND TESTING

1. Purpose : To ensure proper sampling and testing

1. Responsibility : Q.C Officer/ Analyst

2. Procedure:

1. Take necessary preparations for sampling after getting test request with
certificate of analysis from ware house
2. Observe drum(s)/ bag(s) of the item carefully and check out the name
of manufacturer, mfg. date, exp.date locked or unlocked. If everything
is Ok then go for sampling. In case of any problem or doubt, inform to
QC Manager.
3. Open the lock of the container(s) and collect sample from top, middle
and bottom of the container.
4. Sampling system: √n+1, if all containers are sound and same batch
number.
5. Collect sample individually if any broken container.
6. Make a blend of all collected sample of the same item and use for assay
7. Carry out tests according to standard test procedure of the particular
material.
8. Identification test of all items (active or excipients) must be carried out
before going for production.
9. Put the approval or Rejection Tag on the container (s) of tested item (s)
10. Keep record properly