| Dispensing And Issuance Of Raw Material To Production |
1.0 OBJECTIVE: 1.1 To lay down the procedure for Dispensing and issuance of Raw materials to Production. 2.0 SCOPE: 2.1 This procedure is applicable for the dispensing and issuance of raw materials to production. 3.0 RESPONSIBILITY: 3.1 Assistant– Warehouse is responsible to provide the material for dispensing to production personnel and issue the material as per the dispensing sheet. 3.2 Officer–Warehouse shall be supervising dispensing operation and update material issuance in the “stock ledger register”. 3.3 Officer Production shall be responsible to cross check the dispensing activity on his presence while dispensing. 4.0 ABBREVIATIONS 4.1 SOP : Standard Operating Procedure 4.2 QC : Quality Control 4.3 A.R. No. : Analytical Reference Number 5.0 PROCEDURE:(Dispensing And Issuance Of Raw Material) 5.1 Receiving Indent: 5.1.1 Check Raw Material dispensing sheet received from production department for Product Name, Batch Number, & Quantity. 5.1.2 Check Stock Ledger Register for availability of stock against dispensing sheet. 5.1.3 Mention the analytical reference number from Stock Ledger Register on raw material dispensing sheet for all items on First in First out basis. 5.1.4 Note: Incase of expiry. First issues the material which is expiring first. 5.1.5 Check for Quality Control approved label and verify the Analytical Reference Number mentioned on the container against that given in the indent form before issue. 5.2 Pre-Dispensing Activities:(Dispensing And Issuance Of Raw Material) 5.2.1 All the operations perform under Reveres Laminar Air flow booth. 5.2.2 Transfer the materials to be dispensed, by trolleys or by other suitable means from approved storage area to dispensing room. 5.2.3 Ensure the entry procedure to the dispensing area as per SOP. (Entry, Exit procedure for warehouse, sampling booth and Dispensing Area). 5.2.4 Clean the containers with clean duster in material entry area before transferring the material to the dispensing area. 5.2.5 Ensure to keep (after cleaning) all required dispensing aids, clean scoops Status labels, and poly bags, cable ties and other accessories close to dispensing booth. 5.2.6 Bring required containers first to material holding room and then transfer one container at a time to the dispensing room. 5.2.7 In case of additional requirement, bring the required container of the same materials at a time in the dispensing booth. 5.2.8 Always ensure that one container is opened at any point of time, and second container is opened after the complete closure of the first container. 5.2.9 Always ensure to avoid the dispensing of the Active Pharmaceutical Ingredients and excipients at a time to avoid cross contamination sequence of dispensing will be as follows, Excipients API Colour 5.2.10 Take the required material container to be dispensed through material lock to the dispensing room. 5.2.11 At a time, transfer only one material to dispensing area. 5.2.12 Use fresh hand gloves and cleaned scoop for dispensing. 5.2.13 Use fresh hand gloves for dispensing of each active ingredient/ colour dispensing. 5.2.14 Keep the material containers on the provided trolley. To read this SOP click here SOP for Cleaning And Storage Of Dispensing Tools. 5.3 Dispensing Activity: 5.3.1 Warehouse Assistant must carry out all operations in his presence of Quality Assurance personnel and Record the activity as per format no. XXX. 5.3.2 Ensure to issue loose container first. 5.3.3 Check the status of the required material physically for the following: 5.3.4 QC Approved labels. 5.3.5 Analytical Reference Number. 5.3.6 Retest date/Expiry date. 5.3.7 Ensure that the posture of the body should in a way that the filtered Airflow should come direct on the container. 5.3.8 Keep a fresh double poly bags one inside the other on the platform of the balance, in which materials is to be dispensed and check the tare weight of the poly bag and record in “Dispensed” tag as per Format No XXX. 5.3.9 Push the “Tare” button of the balance and wait for dispensing until “zero” 5.3.10 Use the same poly bag in the balance and start scooping the material from the material container to poly bag till the required weight of material is not come. 5.3.11 After scooping take out dispensed poly bag from the balance and push the button of “zero” and load the same poly bag in the balance again to cross check the gross weight of the material. The “Dispensed” tag gross weight and actual weight must be tally. 5.3.12 After the required quantity is weighed, tightly close the inner poly bag with a cable tie. 5.3.13 Prepare duly signed “Dispensed “Tag as per WH008-F01-00., for each material. Insert the Dispensed Label in between outer poly bag and inner poly bag. 5.3.14 Tie the outer poly bag with cable tie. 5.3.15 Ensure the dispensed materials are intact, well identified batch wise and safely closed. 5.3.16 Incase of dispensing of same component for more than one batch, continue the dispensing of the material, batch wise in succession. 5.4 Post Dispensing Activities: 5.4.1 Weigh the left over material containers after dispensing, closed and transfer back to respective location, after affixing the “Loose Container” Label. 5.4.2 Ensure the proper sealing and re- packing of the original container, from which the materials has been dispensed. 5.4.3 Ensure the dispensed materials are well-identified batch wise and safely placed on the pallets in material dispensed room. 5.4.4 Transfer the dispensed material pack, belonging to one batch of a product on the SS pellet through Material Pass Box to the production area along with a BMR. 5.4.5 After completion of dispensing activity, warehouse personnel shall sign and put date in ‘Issued By’ column and Production Officer shall sign and put date as a safe receipt of the material on the material dispensing sheet. 5.4.6 Switch off the Laminar Air Flow, weighing Balance and lights. 5.4.7 After dispensing, accessories / tools shall be covered in a poly bag and transfer to wash area for washing as per the SOP. 5.4.8 Clean the dispensing booth and area as per SOP. Note: No sterile materials shall be dispensed in warehouse; only intact containers are sent to production. |
