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Wednesday, May 12, 2010

STANDARD OPERATING PROCEDURE Title: ISSUANCE AND DISPENSING OF MATERIALS

1. Purpose

This procedure is established for dispensing of Raw / Packaging material as per requisition raised by production department.

2. Scope

This Procedure is applicable to store department.

3. Responsibilities

1. Manager Stores

2. Production Pharmacist

3. Assistant Manager (stores)

4. Quality Assurance Incharge / Officer

4. Procedure

1. Raw materials / Packaging material requisition is raised by production department against which the materials are transferred in the designated dispensing area.

2. Store Manager / Assistant Manager Stores will cross match the batch requirements with product specifications in the presence of QA Officer.

3. Dispensing area is properly cleaned and balance is checked and assured that it is in proper working condition.

4. All irrelevant materials / items are removed from dispensing area.

5. Items name, Quantity, Product name and batch # is mentioned on Polly bags and containers or pasted with dispensing slip.

6. Each item is dispensed as per batch requisition.

7. The materials issued / dispensed are entered in the ledgers against product name and its batch #.

8. The dispensed materials are placed in dispensing trolley and are informed to production department.

9. The dispensed materials are counter checked by production pharmacist and then transferred to production area.

10. The whole dispensing procedure is performed in the presence of QA Personal and Store Manager / Assistant Manager Stores.

11. After dispensing the dispensing area is cleaned and scoops are washed.

5. Precautions:

1. All the persons involved in dispensing process must wear proper uniform, disposable gloves and cotton masks.

2. Dispensing area must be cleaned before and after dispensing.

3. Potency of all materials must be adjusted as per QC results.

4. All scoops must be cleaned before and after dispensing.

6. Quality Record(s)/Form(s)

The following quality records shall be generated and managed in accordance with the procedure for Control of Company Quality Records (4.12)

Required Record

Form Reference No.

Packaging material request sheet

QF/082/01

Raw Material Request Sheet

QF/035/01

Stock (inward & outward) position log

QF/106/01

Dispensing Slip

QF/111/01

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