DISPENSING AND ISSUANCE OF PACKING MATERIAL TO PRODUCTION

• OBJECTIVE:

• To lay down the Procedure for Dispensing and Issuance of Packing Material to Production department.

• SCOPE:

This SOP is applicable for the procedure of dispensing and Issuance of Packing Material to the Production department at {Company Name} {Location}.

• RESPONSIBILITY:
• WH Executive/Designee – is responsible for ensuring compliance with the SOP.
• Production Head- Shall be responsible to ensure the compliance as per SOP.
• Quality Assurance– is responsible for giving line clearance
• Head Warehouse – is responsible for compliance of the SOP.
• ACCOUNTABILITY:

  QA Head shall be Accountable for implementation of SOP.

• PROCEDURE:
• • Precaution/Pre-Checks:
    • Before dispensing, the Warehouse Personnel shall ensure the cleanliness of dispensing area, Weighing Balances and Material Handling Equipments.
    • Ensure that the poly bags to be used for the dispensing of primary packing material are clean and free from any foreign particles.
    • Make sure that the container/pack of the material to be dispensed is having approved labels.
    • If any empty containers/bags/boxes are available in the area it shall be sent to the scrap yard after defacing/crossing of the status label/vendor label.
    • Ensure that the required environmental conditions are as per requirement.
    • The outer surface of the material containers shall be cleaned prior to arranging the materials into the dispensing corridor.
  • Dispensing Procedure:
    • On receiving the indent through Batch Packaging Record from production department, check for the physical availability of the stock & quantity against BPR. Then fill the required quantity and Lot No. in the Batch Packing Record for dispensing of packing materials as per FIFO basis.
    • Packing Personnel/Executive shall calculate and fill the required quantities of packing materials in dispensing sheets.
    • Check the cleaning/calibration of the weighing balance before starting the dispensing.
    • Warehouse Executive/Personnel shall take Line clearance from QA for dispensing activity as per current version of SOP.
    • If any campaign dispensing is required for the same product, same strength and count/pack, then the dispensing of campaign batches shall be carried out for maximum three batches (It can be vary as per campaign study).
    • Warehouse Personnel shall fill Lot No. of packing materials in dispensing sheets on a FIFO basis.
  • Dispensing of Primary Packing Material:
    • Warehouse Personnel shall arrange the required quantity of primary packing materials from packing material store and transfer the same to packing material dispensing room. The outer boxes of the primary packing materials shall be removed inside the primary packing material dispensing room and the loose quantity (if any) required for the batch shall be dispensed under LAF in separate poly bag by using hand gloves. Aluminum foils and PVC films shall be issued on weight basis to the nearest required quantity in poly bags.
    • After issuance of the batch, the left-over loose material shall be packed in a poly bag and it shall be secured with cable tie. For the purpose of identification of quantity “LOOSE MATERIAL” Label shall be pasted on the poly bag after recording the quantity, item code and lot number and the same shall be placed in a box/container.
    • The Warehouse person shall write the loose quantity on the label along with the item code and lot no of the material and existing location code (if any) on the box/container and duly signed.
    • The material shall be placed at the respective storage location.
    • Warehouse Personnel shall check the identity of materials with respect to material approved status, Name of Material, Material Code and Lot Number as per respective packing material dispensing sheet.
    • Production personnel shall verify the identity of materials with respect to material approved status, Name of Material, Material Code and Lot Number as per respective packing material dispensing sheet.
    • All primary packing materials shall be dispensed in double layered poly bags.
    • If the intact primary packing materials are packed in double layered poly bags by the vendors, then the material shall be given in the original poly bags (it may be given in new poly bag also as per internal system).
    • If the vendor has given the primary packing materials in single poly bag, then material shall be covered by an additional poly bag and shall be issued to production after removing the outer corrugated box.
    • Foils/PVDC/PVC film shall be dispensed on weight basis by considering the vendor given net weight for the required quantity given in BPR. If any MRN material is available in stock then such material shall be dispensed first. The intact rolls shall be dispensed as it is with the supplier given shrink-wrapped foil. In case of sampled/opened rolls, the same roll shall be dispensed with a separate poly bag.
    • Container/closure shall be dispensed on a count basis by considering the vendor given quantity on intact boxes. If any loose quantity is required, the same shall be dispensed on a count basis under LAF and shall be given in double layered polybags.
    • Cut form silica gel/activated carbon sachets and canister shall be dispensed on count basis by considering the vendor given quantity on intact boxes.
    • The loose quantity (if any) required shall be dispensed by considering the weight of single sachet (i.e. if required loose quantity is 1000 Nos for 2gm silica gel, then 2gm silica gel x 1000 no’s = 2kg) shall be dispensed under LAF with double layered poly bags.
    • While Cut form silica gel/activated carbon sachets and canister are dispensed the Warehouse Personnel shall ensure that the shelf-life indicator label is placed inside the bags of silica gel sachet.
    • Roll form silica gel/activated carbon sachets shall be dispensed roll wise as per vendor given quantity in intact pack.
    • If any MRN material is available in the stock, then first issue the MRN material to production and the remaining quantity shall be issued on roll wise to the nearest higher value of the required quantity.
    • During receipt of the MRN of silica gel bags, Warehouse Personnel shall ensure that the shelf-life indicator label is placed inside the bags.
    • Whenever the MRN material of silica gel is issued to production, the Warehouse Personnel shall ensure that the shelf-life indicator label is available inside the bags.
    • The dispensed material shall be transferred to the primary dispensed material hold area with material issue tag after filling the BPR with issuance details of roll form silica sachets.
    • Cotton/Rayon shall be dispensed on weight basis as per the quantity given by the vendor. The loose quantity (if any) shall be dispensed under LAF in separate poly bags.
    • The LAF operation and cleaning shall be done as per the current version of SOP.
    • The dispensing shall be carried out within the safe working zone.
    • The details like quantity, lot no, batch no with issued by sign and date shall be recorded in dispensing sheet.
    • The Material Issue Tag shall be pasted on the poly bag of the dispensed material.
    • While dispensing, Production Executive/Personnel shall verify the material with respect to all the details on the Material Issue Tag and shall sign on checked by column of Material Issue Tag as well as in the verified by column of the packing material dispensing sheets.
    • Dispensed materials shall be transferred to “Dispensed Packing Material Hold” area and shall be kept on the pallets or cages provided by production according to batch number.
    • Inform the packing department about the completion of dispensing activity by forwarding the packing material dispensing sheet.
    • Warehouse personnel shall enter the quantity against the respective batch/lot numbers, to update the issued quantity.
    • Additional dispensing of primary packing materials (Excess materials, if required) shall be issued through additional dispensing packing material sheets.
    • If any urgent primary packing material/printed label dispensing is required for additional quantity, then line clearance shall be taken before performing the dispensing activity.
    • If dispensing of another product is going on, then the materials of running product shall be removed from the dispensing room and the urgent additional material required shall be dispensed first.
    • The details of such a change shall be entered in the logbook.
    • Separate entry for the additional material shall be shown by giving the comment as “Additional” in the remark’s column.
    • When the dispensing of the previous batch is resumed, after the completion of the dispensing of the additional materials, the product and batch details shall be re-entered in the logbook.
    • The issue quantity shall be updated in the stock.
    • Scrap materials like empty shippers/containers, poly bags and covers and other materials (if any) shall be sent to scrap yard after defacing the status label & vendor labels.
  • Issuance of Secondary & Tertiary Packing Material:
    • Secondary and tertiary packing materials like Cartons, Leaflets, Medication guide, Labels, Shippers, Pad, Honeycomb, shrink film and self-adhesives tapes etc. shall be dispensed in respective material storage area on count basis by the Warehouse Person as per BPR.
    • For all printed packing materials, at the time of dispensing, the production personnel shall verify the quantity of intact boxes randomly by opening and counting the inner pack. i.e. if printed carton is supplied in 10 boxes with 5000 each quantity and inside the boxes there are 10 small packs of 500 nos of printed carton, then open one box and count number of small packs inside box and verify the quantity. If any variance is observed, then same shall be informed to QA department for further action.
    • Warehouse personnel shall arrange the required materials on pallets according to batch number. Fill the material issue tag and affix on the material outer containers/boxes based on the pack size. The loose quantity shall be issued in poly bag and put the poly bags containing the loose quantity of different materials (in different poly bags) in plastic crates and seal it with cable tie. After arranging all the required materials for a batch or as per campaign batch, transfer the materials to the secondary packing hold area.
    • Once the dispensing is over, the batch quantity of the issued material shall be updated
    • After dispensing, the materials shall be segregated according to lot number and send to the respective areas for storage.
    • Roll form sticker labels shall be dispensed by using roll label counting machine as per SOP by taking proper line clearance from IPQA. After dispensing, the printed labels shall be packed in poly bag by affixing material issue tag.
    • While dispensing, Warehouse Personnel shall check the identity of materials with respect to material approved status, Name of Material, Material Code and Lot Number as per respective packing material dispensing sheet.
    • Production Executive/Personnel shall verify the material with respect to all the details on the Material Issue Tag and shall sign on checked by column of Material Issue Tag as well as in the verified by column of the packing material dispensing sheets.
    • Place the stickers on plastic crate and seal the crate with cable tie. Transfer the crate to secondary packing material hold area.
    • After issuance of the batch, the left-over loose material shall be packed in a poly bag and it shall be secured with cable tie. For the purpose of identification of quantity “LOOSE MATERIAL” Label as per Format-II shall be pasted on the poly bag after recording the quantity, item code and lot number and the same shall be placed in a box/container.
    • The Warehouse person shall write the loose quantity on the label along with the item code and lot no of the material and existing location code (if any) on the box/container and duly signed.
    • The material shall be placed at the respective storage location.
• REFERENCES:

Not Applicable

• ANNEXURES: 

ANNEXURE NO	TITLE OF ANNEXURE
Annexure-I	Material Issue Tag (Label)
Annexure-II	Loose Material (Label)

•  DISTRIBUTION:

• Controlled Copy No. 01  :    Head Quality Assurance
• Controlled Copy No. 02  :    Head Warehouse
• Controlled Copy No. 03  :    Head Production
• Master Copy                    :    Quality Assurance Department
• ABBREVIATIONS:

PGH	:	Pharmaguidehub
No.	:	Number
SOP	:	Standard Operating Procedure
FIFO	:	First in first out
QA	:	Quality Assurance
BPR	:	Batch Production Record
QA	:	Quality Assurance
AHU	:	Air handling unit
RM	:	Raw Material
PM	:	Packing Material

• REVISION HISTORY:              

CHANGE HISTORY LOG

Revision No.	Details of Changes	Reason for Change	Effective Date
00	New SOP	Not Applicable	To Be Written Manual

Frequently Asked Question ?

Q: What are the key pre-checks performed before dispensing primary packing materials?

Answer: Before dispensing, the warehouse personnel ensure the cleanliness of the area, equipment, and poly bags. They verify labels on containers, handle empty containers properly, and maintain required environmental conditions. Additionally, the outer surfaces of material containers are cleaned before entering the dispensing corridor.

Q: How is the dispensing quantity determined and recorded?

Answer: Upon receiving an indent, the required quantity and lot number are filled in the Batch Packing Record based on FIFO (First-In-First-Out) principle. Packing personnel calculate and fill quantities on dispensing sheets. Line clearance is obtained from QA before commencing dispensing.

Q:How are different types of primary packing materials dispensed?

Answer:

• Loose materials: Dispensed under LAF in separate poly bags using gloves. Weight is recorded for aluminum foils and PVC films. Leftover loose material is packed in a labeled poly bag and placed in a container.
• Rolls/containers/closures: Dispensed on count or weight basis with intact boxes preferred. Loose quantities are dispensed under LAF and double-bagged. Shelf-life labels are ensured for silica gel.
• Cut form silica gel/activated carbon sachets and canisters: Dispensed on count basis, with loose quantities dispensed under LAF and double-bagged. Shelf-life indicator labels are included.
• Cotton/Rayon: Dispensed on weight basis, with loose quantities dispensed under LAF in separate poly bags.

Q:How are dispensed materials handled and documented?

Answer:

• Dispensed materials are transferred to a designated hold area with a material issue tag.
• Details like quantity, lot number, and issued by information are recorded.
• Production & IPQA personnel verify materials against the Material Issue Tag and sign off.
• Dispensed materials are transferred to the designated hold area and pallets/cages.
• Packing department is informed upon completion of dispensing.
• Stock is updated with issued quantities.

Q:How are secondary and tertiary packing materials dispensed?

Answer:

• Dispensed on count basis by warehouse personnel in designated areas.
• Printed materials are randomly verified by production personnel.
• Materials are arranged on pallets and labeled, with loose quantities in separate poly bags.
• Roll form stickers are dispensed using a counting machine after line clearance.
• Production personnel verify materials and sign off.
• Leftover loose materials are labeled and stored.