SOP for Dispensing of Raw Materials

OBJECTIVE

To lay down a procedure for dispensing of approved raw materials for production. 

SCOPE

This procedure applies to the Warehouse Department Formulation division. 

RESPONSIBILITY

• Raw material warehouse personnel to follow the procedure. 
• The dispensing chemist is responsible for the execution of the procedure. 
• Warehouse in charge of ensuring compliance. 

PROCEDURE

• On receipt of the "Raw material requisition cum issue slip " for the manufacturing of a batch of the drug product., the store's personnel shall check for all details such as the Name of the product, Batch Number, Batch size, etc., 
• The store's personnel shall check the AR No. of the raw material to be issued from the ‘Material bin card' against each raw material on first in first-in-first-out basis. Check the details on the container such as expiry date/retest date on the approved label or any other 'Hold' status label on the container of raw materials.

• The production in charge shall check the Assay and LOD/Water values wherever applicable for dispensing of active raw materials, on the certificate of analysis and calculate the quantity to be dispensed. The same shall be counter-checked by Quality Assurance personnel (Dispensing chemist). 
• The quantity of the specified excipients to be adjusted as per the quantity of active raw material, that is dispensed shall also be calculated by the production in-charge and the same shall be counter-checked by QA personnel (Dispensing Chemist). 
  
• Collect individual, approved raw material containers from the racks onto pallets/trolleys and remove any dust on containers with a vacuum cleaner or lint-free cloth. 
• Transfer material through the pass box to the dispensing area. 
• Transfer the respective material from the pass box to be weighed to the dispensing room. Dispensing personnel shall wear hand gloves and mouth masks before weighing. 
• Before weighing, the store personnel and Quality Assurance personnel (Dispensing chemist) shall ensure that the area is cleared for dispensing and the dispensing aids such as scoops, spoons, and SS containers in which the weighed raw material will be transferred, have been cleaned. 

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• Ensure that the laminar airflow (LAF) is switched ON before beginning any weighing operation. 
• Ensure that the balance is in a calibrated state. Check the tare weight (x) of the container or poly bag in which the material is to be weighed. Add the quantity of the raw material to be weighed (y) to the tare weight. Start transferring the material with a scoop or spoon into the polyethylene bag /SS container to get a gross weight of (x+y) kg. The net weight transferred will be (y) kg. 
• Enter the Tare weight, Gross weight, and Net weight in the Weighing record. All the weighing is to be counter-checked by one warehouse personnel, and quality assurance personnel (Dispensing Chemist). 
• Production personnel shall verify the gross weight, tare weight, and net weight of containers issued.

• Active raw material for a batch shall be dispensed after dispensing of other inactive raw materials for that batch and after removing all containers of inactive material from the dispensing area. 
• Empty hard gelatin capsule shells can be dispensed on a weight basis. 
• warehouse personnel shall check the average weight of the empty capsule as mentioned on the respective Goods receipt Note, and calculate the weight of the capsules to be dispensed. Calculations shall be counter-checked by QA personnel (Dispensing Chemist). 
• Tie the polyethylene bag of the dispensed material with nylon thread and if it is an SS container, close it with lid. Label the dispensed material with the respective 'R.M SLIP' (Annexure No.:1) on the outside the container. 
• After completion of dispensing, close all the containers properly and transfer them to the respective approved raw material storage area. 
• Hand over the original copy of the Raw material requisition cum issue slip, completed in all respects to concerned Production personnel, and retain one copy. 
• Keep the Dispensed material in the staging area. 
• Clean the dispensing room and dispensing aids as per the respective SOPs. 
• Enter the details of each raw material dispensed for the batch in the respective 'Material bin Card'.

ABBREVIATION

Q.A - Quality Assurance 

Q.C - Quality Control 

SOP - Standard Operating Procedure 

No. - Number 

W.H - Warehouse 

R.M - Raw materials

ANNEXURE

Nil

REVISION HISTORY

Nil

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