Tuesday, July 29, 2008

SOP - store procedures

SOP: Cleaning Procedure for Raw Material Stores Dispensing Equipments
For every drug substance its dedicated equipments is used. On each piece of equipment name of the drug substance for which it is reserved has been engraved. Dispensing equipment's used for excepients is not dedicated. However, cleaning procedure for all the equipments is same. After completing the dispensing operation, the dispensing equipment is carefully wrapped in a polythene bag and placed in a plastic box, which has been labeled as “USED SCOOPS, SPATULAS FOR CLEANING”.
The Equipment is scrubbed with 2.0% TEEPOL solution and rinsed under running tap. To remove sticky substances, the equipments are rinsed with hot water and scrubbed with 2.0% TEEPOL solution after rinsing under running tap water. The equipment is rinsed with distilled water and allowed to drain. Then the equipment is sprayed with 70% IPA and dried with hand held drier. The cleaned and dried equipment is wrapped in aluminium foils and covered with kraft paper. Affix “CLEAN & READY FOR USE” label.

SOP: Operating Procedure for Raw Material Dispensing

Procedure :

Before commencement of any weighing the balance should be checked for its “0” position and there should be no dust on the platform, weighing bowl, dial or beam. Dust extraction system and positive pressure modules should be “ON” and doors should be closed. When materials are weighed, Name of the Material, Tare Weight, Gross Weight and Nett Weight of the material being dispensed should be noted for each item and should be recorded. When two lot numbers are used to makeup the required quantity, quantity of each lot should be recorded. The material should be dispensed clearly labelled with Name of the Material, Batch No, QC Control No, Name of the Product (for which it is dispensed) the Nett Weight, Gross Weight. Upon the receipt of dispensed raw material labeling and indicated weight should be checked. All the container should be weighed individually and gross weight should be cross checked. The weighing tag should be signed by three individuals by the dispensing person (1); Production Supervisor / chemist (2); Stores incharge / supervisor (3).

For formulations all the weights are cross checked with master formula card with their corresponding batch size.

For new products the following persons should cross check weight of all the ingredients.
1. Weighing Person

2. Production chemist / supervisor

3. Store supervisor / manager

4. Production manager

5. QC manager

6. Factory manager

7. Director / Works
SOP : Cleaning Schedule for Quarantine Raw Material Stores

Wipe the entire walls and glass windows with clean towel every day.

Clean the entire floor using vacuum cleaner every day, and the dispensing area immediately after every weighing.


1. Clean the weighing stones once every day.
2. Clean the balance every day without disturbing its position and every time between weighing of different raw – materials.
3. Wash the utensils and dry the same between weighings of different raw materials.

Clean it with towel and vacuum cleaner.

SOP : Operation Procedure for Quarantine Maintenance

Procedure :

As soon as the material arrived into the quarantine the following points are to be checked.

1. Check if the supplier Name is in the approved vendor list.

2. Check the condition of the packing, Mfg Date, Exp Date.

3. Check the weight / units of the consignment.

4. Check the purchases order No and the ordered qty and the required date with the DC.

5. Place the material in a proper position and it should be easily identifiable.

6. Affix “UNDER TEST” label on each container or pack.

7. Under test slip should have the following details :
Name of the Material, B.No, Mfg Dt, Exp Dt, Name of the Manufacturer, Name of the Supplier, Qty Received, Gross Wt, Nett Wt, Chellan No / D.C. No, Date.

8. Record the receipt in the Stores Ledger.

Precaution : Follow the same procedure for old materials which is sent for re-analysis.
All the materials should have Name of the Material, Initial analysis date, and percentage of purity, B.No, Mfg Dt, Exp Dt, Name of the Manufacturer, Name of the Supplier, Qty Received, Gross Wt, Net Wt, Chellan No / D.C. No, Date. And the label should state that “For Medicinal Use Only” And It Should Not Have “Not For Medical Use” “For Animal Use Only” “Not For Human Use” …. like that.

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