March 3, 2023 by KBS.

The responsibility for the proper receipt, storage, and tracking of materials lies with all personnel involved in the process, including but not limited to procurement staff, warehouse staff, and inventory management staff. The SOP for Receipt & Storage of Materials in Pharmaceuticals ultimate accountability for compliance with this SOP rests with the management of the organization. All personnel involved in the receipt, storage, and tracking of materials must be trained on this SOP and must adhere to its provisions. Any updates to this SOP must be communicated to all relevant personnel and training must be provided accordingly.

Table of Contents

PURPOSE:

To lay down a procedure for receiving the raw materials and packaging materials.

SCOPE:

This SOP is applicable for receipt of Raw and Packing material to the warehouse of the pharmaceutical formulation plant.

RESPONSIBILITY:

Technical Operation Director.
Q.A. Manager.
Q.A. Officer.
Warehouse Supervisor

REFERENCE:

In-house

PROCEDURE:

Receipt of the Material

Upon arrival of the vehicle with material, the security personnel checks the delivery documents and ensures that consignment is meant for pharmaceutical formulation plant.
After confirmation of the address, the documents related to the consignment shall be sent to warehouse office for verification before making entries into “Security Register for Incoming RM/PM”.
Warehouse Personnel shall collect the documents through window and check the following in the delivery documents (delivery Challan / invoice).
• Appropriateness of company address on the delivery documents.
• The vendor is approved as per current version of Approved Manufacturer / Supplier List, including address.
• Availability of Vendor Certificate of Analysis copy.
• Reference of Purchase Order number on the delivery documents.
• Description of the material (Material name, grade/ pharmacopeia status, quantity) in purchase order tallies with that mentioned in delivery document.
In case of any discrepancies observed in the above mentioned points, shall be informed to HOD – Warehouse, and HOD – Purchase for corrective action, and vehicle should not be allowed to enter if applicable.
After ensuring the adequacy of the received documents; the warehouse personnel shall send back the documents to security personnel to make entries in the “Security Register for Incoming RM/PM”.
Security personnel shall make entries in the “Security Register for Incoming RM/PM”, after receiving the consignment documents from warehouse.
Allow the vehicle to enter in to the plant premises.

Pre-unloading activities

SOP for Receipt & Storage of Materials in Pharmaceuticals

Upon arrival of the vehicle of material at unloading area, carry out the following activities.
• Ensure that the vehicle is covered properly to protect the material.
• Instruct the vehicle driver to stop the engine to avoid carbon spillage from silencer, till completion of unloading and transfer of material into Material Receiving Area.
• Ensure cleanliness of vehicle.
• Warehouse personnel shall check the consignment to ensure absence of material other than mentioned in the delivery documents, in order to avoid mix-ups.
• Ensure that the Vehicle is not carrying any pesticides or oily material and shall be free from abnormal odor.
• Ensure the material receiving area is clean before unloading the material.
• Ensure the cleanliness of the dedicated pallets available at the receiving platform.
• Ensure the cleanliness and working condition of the Hydraulic pallet trolley vacuum cleaner.
• Ensure the air curtain is in working condition.
• Before starting the De-dusting operation ensure that the inside door is closed.
• Ensure the weighing balance is calibrated.

Unloading activities

The material shall be unloaded from the vehicle under supervision of warehouse personnel.
Ensure to unload the material safely from the vehicle onto the cleaned dedicated pallets on the receiving platform.
Open the door of Material Receiving Area to receive the material. Ensure that the other door of the room is closed.
Transfer the loaded pallets with material into Material Receiving Area and keep them in the area meant for cleaning/ de-dusting of received materials.
The Warehouse personnel shall verify each Container, Bag, Box or Drum Identification integrity in terms of physical appearance of the consignment against the “Consignment Check List for Raw Material & Packaging Material”. The following details shall be verified.
• Material Name (To match with COA and Label on the received pack)
• Supplier/ Manufacturer Address. (To match with Approved Vendor list)
• Batch Number (where ever applicable).
• Manufacturing date (if available on the container/ Certificate of Analysis copy.)
• Expiry date / Retest date. (As available on the container/ Certificate of Analysis copy).
• Check any storage conditions are mentioned on the container label.
Deface the supplier’s / Manufacturer’s approved label available on the container / pack by making “X” mark by marker pen.
Physically verify all the unloaded containers / packs, for identification, integrity, intactness of seal, and Quantity as per Delivery documents.
If it is tallied, acknowledgement for material receipt is given to the driver of the vehicle by stamping sign on the copy of the delivery documents.
• In case of any shortage, damaged, broken or tampered materials (occurred due to the fault of transporter) is received, the same nature of remarks shall be mentioned on all copies of delivery documents and sign of the driver should be taken as a confirmation.
• Communication is given to Quality Assurance department by raising the “Material Discrepancy Report”, to review the impact, and to initiate further action.

DE-DUSTING PROCEDURE

De-dusting of the containers / packs for API and Excipients.
• Clean the external surface of the container one by one by using the vacuum cleaner.
• Rotate the container sideways and ensure the vacuum suction cleans all external surfaces, top and bottom of containers during the de-dusting.
• Clean the container with lint free duster.
• Ensure to handle the containers carefully to avoid falling and loosing of the seal during de-dusting.
• After de-dusting and cleaning, ensure to segregate the material as per batch / lot wise.
• Transfer the cleaned containers on to the clean pallet.
De-dusting of containers / packs for Excipients and Primary Packaging Material in bags/ shippers.
• Clean the external surface of the packs one by one by using the vacuum cleaner.
• Lift the Pack and ensure the vacuum suction cleans entire external surface of the pack during the de-dusting.
• Ensure to handle the packs carefully to avoid falling and damage to the external surface of the pack (Integrity) during de-dusting.
• After cleaning and de-dusting, ensure to segregate the material as per batch / lot wise.
• Transfer the cleaned packs on to the clean pallet.
• After de-dusting the shippers of Lidding foils and forming films shall be opened and the rolls of the foils and films with protective polythene cover shall be transferred into another polythene cover and tied with cable tie before affixing quarantine label and transfer into Quarantine area.
De-dusting of Secondary (Printed) Packaging Material shippers
• Clean the external surface of the packs one by one by using the vacuum cleaner.
• Lift the Pack and ensure the vacuum suction cleans entire external surface of the pack during the de-dusting.
• Transfer the cleaned packs on to the clean pallet.
• Ensure that only one consignment is received and handled at a time to avoid mix-ups.

De-dusting of Un-printed Packaging Material in Bundles.

Clean the external surface of the packs one by one by using the vacuum cleaner.
Lift the Pack and ensure the vacuum suction cleans entire external surface of the pack during the de-dusting.
Transfer the cleaned packs on to the clean pallet kept.

Post de-dusting procedure

Ensure that out side door of Material Receiving Area is closed.
After Completion of de-dusting operation ensure vacuum cleaner is kept in its cover before cleaning.
Ensure the Waste generated in the de-dusting area is disposed off in waste bin provided.
Open the inside door of Material Receiving Area and transfer the containers / packs lot / batch wise for weighing.
Ensure the inside door of Material Receiving Area is closed.

Weighing or Quantity verification procedure

Transfer the containers / packs by using pallet trolley with lot wise to the weighing area.
Check for the cleanliness of the balance and ensure its routine calibration as per respective SOP No.
Switch on the balance and wait till zero display comes.
Weigh the containers/packs received one by one, on the balance provided and ensure that quantity received is tallying as mentioned in delivery documents.
Record the gross weight in.
In case of any discrepancy in the material, prepare “Material Discrepancy report” and inform to vendor through purchase department.
After completion of weighing, “switch off” the balance and ensure for its cleanliness.
After weighing the packs, shall be kept on pallets for storage.
Note: All the API containers, Excipients containers/ packs, forming film/ lidding foil rolls shall be verified for their gross weights. Other Primary packaging material and secondary Packaging Material shall be verified for their quantity in numbers against the received documents.

Quarantine Procedure

Affix “Quarantine Label”, on the packs and shift them to their respective quarantines.
Transfer the material to respective Quarantine area and store the material as per recommended storage conditions.
Ensure the cleanliness of the storage racks.
Stack the materials in designated storage racks.
The warehouse personnel shall enter the material details in “Incoming Material Register (Raw material)”and “Incoming Material Register (Packaging material)”.
Warehouse-Personnel shall prepare the GRN (Goods Received Note).
The received material quantities shall be updated in the “Material Stock Card”.
Send Goods Received Note (GRN) to Quality Assurance Department.
Quality Assurance Department shall initiate for material sampling.
Co-ordinate with Quality Assurance officer for batch wise sampling.
Quality Assurance personnel shall do the sampling from the received material, and affix “Sampled” labels duly filled & signed on the containers/ packs which have sampled for testing.
Ensure the sampled containers/packs are re-sealed properly and repacked and send to its respective location.
Quantity of sample withdrawn by Quality Assurance personnel shall be recorded in GRN and warehouse personnel shall transcribe the quantity into “Material Stock Record”.

Approval/ Rejection

After analysis, Quality Control shall send back the Goods Receipt Report (GRN) to warehouse indicating the material status (Approved or Rejected) along with the Certificate of Analysis.
After Testing and Release of the materials by QC, each container with “Quarantine” label shall be affixed with “Approved” label duly filled & Signed by Quality Control Personnel.
Warehouse personnel shall transfer the Approved material from “Quarantine area” to the respective Approved material Storage areas. Transfer shall follow “Labeling and Storage of Raw and Packaging Material”.
Rejected material (If any, by QC) it shall be labeled as “REJECTED” duly filled & signed and shall be transferred to Rejected material room.
The details of the rejected material shall be informed to the Purchase department for further action.

Handling of shortages/ Improper labeling (Identification)/ damaged consignment:

Shortages:

If number of packs received is less than that indicated in the documents and Purchase Order note the details of shortage on the Transporter Bill.
Take signature from the driver.
Inform HOD-Warehouse and HOD-Purchase by telephone/ e-mail.
Upon approval by HOD Purchase and/ or Plant Head the material may be accepted with a shortage note in the “Material Discrepancy report”.
Further action on commercial aspects with the Vendor shall be taken up by Purchase Department.

Improper labeling/ Identification:

Any discrepancy in terms of improper labeling/ Identification of the containers/packs against the PO and documents shall be immediately inform to HOD – Warehouse, Head-Purchase.
If the discrepancy is confirmed that material received shall be kept in the Rejected material room.
The material shall be rejected with a note in the “Material Discrepancy report”.
Further action on commercial aspects with the Vendor shall be taken up by Purchase Department.

Damaged Goods:

If the received material is physically in damaged condition:
Note the details in the “Material Discrepancy report”.
Inform to HOD–Warehouse-Purchase and Plant Head.
If Raw material and API containers/ packs received in damaged condition:
o Minor damages like dents are acceptable for Raw materials.
o Minor damages are not acceptable for sterile API and the material should be rejected.
o Transfer them to rejected material room after affixing the “INPROCESS -REJECTED” label.
If printed packaging material is received in damaged condition and are not in usable condition.
o Transfer them to rejected material room after affixing the “INPROCESS -REJECTED” label.
o Inform the purchase department.
o Printed packaging material should not be returned to the vendor.
o These materials must be destroyed inside the plant after getting approval from HOD-QA and Plant Head in presence of QA and Vendor representative/ vendor concurrence.
If un-printed packaging material received in damaged condition.
o Transfer them to rejected material room after affixing the “REJECTED” label.
o These can be sent back to the vendor.
If primary packaging material is received in damaged condition.
o Damaged packs shall be segregated from the good packs.
o Good packs may be acceptable after QC and QA verification.
In case of damage in the consignment of Raw Material and Packaging Material except printed packaging material, as explained above, shall be sent back to the manufacturer/ supplier, along with ‘Gate Pass Returnable / Non-Returnable’ detailing the reason for return appropriate transport system.