SAFFRON PHARMACEUTICALS (PVT.) LTD.

PRODUCTION DEPARTMENT Title: Standard Procedure for Preventing Contamination and Mix up of Semi manufactured/Bulk products during their Transfer from one place to another
Checked By/on: Production Manager Approved By/on: Quality Assurance Manager
Document#:PR/GN/SP/02 1 Issue date: 08-06-2011 Revision date/#:07-062013/00 Page #: 1/2

Prepared By/on: In-charge Pharmacist

Authorized By/on: Deputy Plant Manager

1. Objective: To provide a procedure for transfer of semi manufactured/bulk products between one step of a process to another in order to prevent their contamination. 2. Scope: It is applicable to all sections of production department in transferring the semi manufactured/bulk products during processes. 3. Responsibilities: i. Section In-charge ii. Production Pharmacist iii. Production Supervisor 4. Procedure: i. Contamination: The undesired introduction of impurities of a chemical or microbial nature, or of foreign matter, into or on to a starting material or intermediate, during production, sampling, packaging or repackaging, storage or transport. ii. Contamination of pharmaceutical products can result in decrease in efficacy and generation of some undesirable effects in the products therefore care should be taken during manufacturing and transfer of materials. iii. While transferring the material to an area for process, make sure that the area is cleaned and free from any material of previously processed batch. iv. The material should be transferred in sealed containers or buckets lined with poly bags to prevent mix up with any other undesirable material.

v. The containers or buckets of material should be properly labeled with Product Name, Batch #, Batch Size and Status of material with initials of production pharmacist to prevent any mix up with materials of any other product or another batch of same product. vi. The equipment used in the process should be free of any material of previous product or remains of cleaning agent to prevent contamination of product. vii.Washed utensils should be used during process. viii. After completion of process, all the material should be carefully drawn out from the equipment and kept in poly bag lined containers or buckets. ix. The material should be transferred to the next processing area or inprocess staging area with the current status of material to prevent mix up with other materials present in that area.

SAFFRON PHARMACEUTICALS (PVT.) LTD.

PRODUCTION DEPARTMENT Title: Standard Procedure for Preventing Contamination and Mix up of Semi manufactured/Bulk products during their Transfer from one place to another
Checked By/on: Production Manager Approved By/on: Quality Assurance Manager
Document#:PR/GN/SP/02 1 Issue date: 08-06-2011 Revision date/#:07-062013/00 Page #: 2/2

Prepared By/on: In-charge Pharmacist

Authorized By/on: Deputy Plant Manager

x. The utensils used in the process should be transferred to the washing area to prevent contamination of any other material or product from them. 5. Distribution list: Production manager, all section in-charges, controlled copy to Q.A. 6. Revision history: Being issued first time