Table of Contents
1.0 OBJECTIVE:
1.1 To lay down the procedure for the receipt, quarantine, intimation to QC, sampling and approval / rejection of raw material.
2.0 SCOPE:
2.1 This procedure is applicable for the receipt, quarantine, intimation to QC, sampling and approval / rejection of raw material in Warehouse.
3.0 RESPONSIBILITY:
3.1 Assistant -Warehouse shall be responsible for the receipt at unloading bay, quarantine and intimation to QC of raw material as per their condition and status.
3.2 QC chemist is responsible for the sampling of the material and clears the status of Approval or Rejection in coordination with Head QC.
3.3 Warehouse In-charge shall be responsible for implementation of the procedure as per the SOP.
To read this SOP click here Preparation Of Chemical Dosing Solution In EDI Plant.
4.0 ABBREVIATIONS
4.1 SOP : Standard Operating Procedure
4.2 QA : Quality Assurance
4.3 CC NO : Change Control Number
4.4 QC : Quality Control.
4.5 GRN : Goods Receipt Note.
4.6 API : Active Pharmaceutical Ingredients
5.0 PROCEDURE:
5.1 Receipt of the Material:
5.1.1 Warehouse department will instruct the security supervisor to allow the vehicle into the factory premises.
5.1.2 Warehouse personnel will collect the document through document pass box and check the following details in the delivery document.
5.1.2.1 Check the correctness of company name & address on the delivery documents.
5.1.2.2 Check that the vendor is approved as per current version of Approved Manufacturer /Vendors List, including vendor address.
5.1.2.3 Check the availability of Certificate of Analysis copy of the material supplied by Vendors.
5.1.2.4 Check the Purchase Order number is mentioned on the delivery documents.
5.1.2.5 Ensure the description of the material in purchase order tallies with that mentioned in delivery documents.
5.2 Pre-Unloading Activities:
5.2.1 On arrival of the vehicle of material at unloading area, Assistant Warehouse carries out the following activities.
5.2.1.1 Instruct the vehicle driver to stop the vehicle on unloading platform.
5.2.1.2 Ensure the material receiving area is clean before unloading the material.
5.2.1.3 Ensure the cleanliness of the pallets on which the material to be unloaded.
5.2.1.4 Ensure the cleanliness and working condition of the de-dusting tunnel.
5.3 Unloading Activities:
5.3.1 Open the backside lock of the vehicle and park the vehicle near platform
5.3.2 Unload the material safely from the vehicle in the presence of security person and ensure the complete unloading.
5.3.3 Warehouse personnel check the material container for external identification label and verify the material and fill the observation in check list as per ERP system and verify the weight of container as per under root n+1 in case of inactive & 100% in case of active.
5.3.3.1 Check any storage conditions are mentioned on the container label.
5.3.4 Check the supplier’s / Manufacturer’s label available on the container / pack.
5.3.5 Ensure to physically verify all the unloaded containers / packs, identification and seal (quantity and condition) as per delivery documents. If it is tallied, acknowledgement is given to the driver of the vehicle by putting the stamp and sign on a copy of the delivery documents.
5.3.6 In case of any damaged, broken or tampered materials (occurred due to the fault of transporter) are received, the same nature of remark is mentioned on all copies of delivery documents and sign of the driver should be taken as a confirmation. And intimation shall be given to Quality Assurance department by raising as per Annexure –I & II of review the impact, and next action is decided after due consultation with Quality Assurance Department.
5.4 De-Dusting Procedure:
5.4.1 Transfer the container one by one through dedusting tunnel.
5.4.2 Clean the external surface of the container by using dry cloth/ lint free duster.
5.4.3 Record the details of cleaning through tunnel in Annexure -XXX.
5.4.4 After cleaning and de- dusting, ensure to segregate the material as per batch / lot wise. Ensure to handle the containers carefully to avoid falling and loosing of the seal during transformation.
5.5 Weighing Procedure:
5.5.1 Before weighing the material ensure that the weighing balance has been calibrated.
5.5.2 Transfer the containers by using trolley and other suitable means batch / lot wise to the weighing area.
5.5.3 Switch ON the balance wait till zero comes. Verify the balance for min. & max. weight
5.5.4 Weigh the containers received one by one, on the balance and ensure that quantity received is tallying as mentioned in delivery documents.
5.5.5 Record the gross in back side of “check list for receipt material as per Annexure -VI.
5.5.6 The Raw Material should be verifying 100٪ in case of API & n+1 for Excipients.
5.5.7 In case of discrepancy (damage/shortage) found in the material, prepare note as per Annexure XXX, and inform to vendor through purchase department.
5.5.8 After completion of weighing switch OFF the balance and ensure the cleaning of balance.
5.6 Post De-Dusting Procedure:
5.6.1 Ensure that out side door of material receiving Tunnel is closed.
5.6.2 Ensure the Waste generated in the de-dusting area is disposed off in waste bin provided.
5.6.3 Weight the containers / packs as lot / batch and transfer to the storage area through lift.
5.6.4 After completion of receiving operation, ensure the cleaning of receiving area.
NOTE: Ensure that the personnel working in de-dusting area do not enter the quarantine area, while transferring the material from de-dusting zone to weighing area.
5.7 Quarantine Procedure:
5.7.1 Ensure the cleanliness of the storage area.
5.7.2 Transfer the material to Quarantine area and store the material as per recommended storage conditions with “QUARANTINE” label.
5.7.3 Stack the materials in designated storage area.
5.7.4 Record the Material in Material Inward Register for RM & PM as per Annexure – XXX or as per ERP system.
5.7.5 After selecting the required series Prepare Goods Receipt Note. – Raw material (Computer slip) for each batch of the raw material received in one consignment of same material.
5.7.6 Make one copy of Goods Receipt Note (GRN) which is created by Computer ERP software and attach with invoice document prepare QC intimation note in duplicate & send all the copy to Quality Control department and get acknowledgement of on copy.
5.7.7 Co-ordinate with Quality Control Chemist for material sampling.
5.7.8 Ensure the Quality Control chemist affix of label “SAMPLED” on sampled container & “UNDERTEST” on all containers.
5.7.9 Ensure the sampled containers are sealed properly and repacked back.
5.8 Approval / Rejection:
5.8.1 After analysis, Quality Control will inform warehouse indicating the material status and mention the Quality Control Approved or Rejected label along with the Certificate of Analysis (In case of active material).
5.8.2 Ensure that Quality control chemist Affixes “APPROVED”/ “REJECTED” (Computer slip label) on all the containers / packs.
5.8.3 In case of rejection, shift the material to the Rejected Material Store area having lock and key facility, just after the receipt of the material affixing the REJECTED labels on the container. Inform to Purchase department for return to vendor along with proper documents and update the list of rejected material as per Annexure –XXX.
5.8.4 Ensure all the status labels are filled properly with date and signatures.
5.8.5 Transfer the material to designate approved area and store under recommended storage conditions.
5.8.6 Enter the Re-testing date into the ERP system.
5.8.7 File the QC intimation note as per order in the file.