Standard Operating Procedure for Dispensing of Packaging Materials
To provide a standard operating procedure for dispensing or issuing Packaging Materials in the warehouse.
The scope of this SOP is applicable for dispensing or issuance of primary and secondary Packaging Materials in the warehouse at [company name].
Warehouse person: Dispensing or issuance of Packaging Materials
Warehouse supervisor: To verify dispensed material details, to record the activities in the Batch Packaging Record
Packaging supervisor: To verify dispensed material details against the standard quantity mentioned in the Batch Packaging Record
QA Person: To accord line clearance
Warehouse Head: To monitor the procedure compliance
5.1. Packaging department person shall initiate a material requisition note for the required product. The requisition will contain details of material name, material code, batch number, and required date.
5.2 Warehouse person shall receive the material requisition note and plan for the material dispensing activity as per material requisition.
5.3 Bill Of Material (BOM) with Packaging Material details (A.R. Number/ Control No.) for the batch to be dispensed shall be provided to the warehouse by the packaging department.
5.4 Material management software shall generate the packaging order where material details shall get arranged automatically based on FEFO (First Expiry First Out) followed by FIFO (First In First Out).
5.5 Only approved material will get populated in the list.
5.6 At a time, single batch material shall be dispensed. An open container/ box of the materials shall be used first for dispensing.
5.7 Ensure that all necessary packaging materials are in the approved state before dispensing and no material is due for a retest.
5.8 Approved packaging material shall be kept ready (through material movement route) after wiping the containers/ outer cover with a lint-free duster. Note: Primary Packaging material shall be dispensed under Reverse Laminar Air Flow (RLAF). Secondary and tertiary packaging materials need not be dispensed under RLAF.
5.9 Warehouse and packaging department personnel shall enter into the dispensing area from the man movement change room for dispensing of primary Packaging materials. Secondary and tertiary packaging materials shall be dispensed at the designated area for material dispensing.
5.10 Warehouse person shall ensure that area is cleaned for dispensing activity before the start of the activity. Accessories used for the dispensing is available with clean status label and instruments such as weighing balance are calibrated.
5.11 Use required Personal protective equipment (PPE) such as hand gloves, nose mask, Earmuff, Earplug, and Goggle while working in dispensing area.
5.12 Switched “ON” the RLAF and allow the area to stabilize for ‘ABC’ minutes. ABC is the stabilization time of RLAF derived from the study.
5.13 Ensure that differential pressure reading on the Magnehelic gauge is within the allowable limit for primary, secondary, and HEPA filters. [Only applicable for dispensing of primary packaging material]
5.14 Ensure that the temperature, relative humidity, and differential pressure of the area are within the acceptable range. [Only applicable for dispensing of primary packaging material]
5.15 Before starting the dispensing activity, line clearance should be done to ensure that area is cleaned, no previous product documents, and the material is available in the area. Line clearance checks for dispensing shall be done by the user department, followed by the QA department. Line clearance shall be recorded in the batch packaging record.
5.16 The dispensing activity shall be carried out under the supervision of personnel from the warehouse and packaging department.
5.17 Container/ material shall be brought into RLAF and placed on the balance to record the tare weight. [As applicable for primary packaging material]
5.18 During dispensing, details to be verified on the material label, such as Description of the material, Item code number, A.R. Number, Retest date, and expiry date.
5.19 Material shall be weighed/ counted as per the quantities defined in BOM. If weighing is required, it shall be done using the weighing balance. Ensure that the correct capacity of the weighing balance is used.
5.20 Material shall be dispensed in the cage/ container having lock and key arrangement for primary packaging material and printed packaging material.
5.21 Warehouse supervisor shall verify the standard quantity mentioned in the batch packaging record to ensure that the correct amount/ quantity of material is dispensed.
5.22 The dispensed material shall be labeled with details such as product name, batch number, material name, item code, A.R. Number, and Lot No.
5.23 Packaging supervisor shall verify the quantity dispensed against the standard amount, material code, A.R. number, gross weight, tare weight, net weight, and other details on the dispensed material label and verify the correctness concerning the batch packaging record.
5.24 Different lots’ materials shall be issued separately.
5.24.1 If material comes as a bundle, a direct bundle can be dispensed to issue the dispensed quantity. If the full bundle is given, the quantity will be more than BOM, and the last quantity will be issued, opening the bundle to issue the exact quantity. Examples of such materials are cartons, leaflets, etc.
5.24.2 Labels shall be issued by counting them in numbers. If the labels are available as Roll labels, the entire Roll shall be given (if the Roll has a counter on the backside of the label).
5.24.3 Shippers shall be issued by counting in numbers.
5.24.4 Silica gel/ oxygen canister can be issued by counting or weighing depending on feasibility. [Company can decide either approach or combination]
5.24.5 Biaxially Oriented Polypropylene (BOPP), drum, pallet, PVC bag, tri laminated high barrier bag, aluminum bag, and plastic seal to be issued by count in numbers.
5.24.6 HDPE bottle, Caps, and closure shall be issued in number in full pack. If numbers differ from the full pack, the remaining quantity to be issued by a count under RLAF.
5.24.7 Cotton/ Rayon coil to be issued by weight basis.
5.24.8 Aluminum foil and PVC/ PVDC film shall be issued in weight. The last Roll shall be issued full even though the quantity is more. The remaining quantity to be returned by the packaging department to the warehouse after completion of the batch. For Aluminum foil and PVC/ PVDC film net weight is calculated using the core weight.
5.24.9 Vial and rubber stopper can be issued in full. If the full quantity differs from the required quantity, a loose pack can be issued if the material is not pre-sterilized.
5.24.10 Pre-sterilized material shall be issued in the manufacturer’s original pack; it should not be issued in loose quantity. While dispensing such material, the integrity of the pack needs to be ensured.
5.24.11 Flip of seals, needle guard, and plunger rod to be issued in full pack. If pack quantity is differing from the required quantity, it can be issued by weight. Standard average weight can be used to calculate the quantity.
5.25 After completing dispensing, the remaining material container shall be transferred to the warehouse at a designated place.
5.26 Used Utensils and accessories shall be labeled with the status label as “Unclean”.
5.27 At the end of dispensing, if any material physical quantity found different from material management software stock, it should be adjusted in the system up to the allowable amount. If the difference is more than the defined acceptable range, it shall be investigated.
5.28 Before starting of next batch, cleaning of area and RLAF shall be performed.
5.29 Cleaning process shall be documented in the area and equipment logbook.
5.30 After completion of dispensing activity, personnel working in the area shall remove the hand gloves and cut them to prevent re-use of it. Discard the gloves in the waste bin.
Every batch packaging
Format for Logbook of primary Packaging material dispensing (Following are the content of logbook)
Following content should be covered in the log book
RLAF Start Time (Hrs.)
Magnehelic gauge pressure reading
Dispensing start time (Hrs.)
Dispensing end time (Hrs.)
Cleaning start time
Cleaning end time
RLAF stop time
RLAF stopped by
Format for Logbook of secondary and tertiary Packaging material dispensing (Following are the content of logbook)
Following content should be covered in the log book
Date of Dispensing:
Product /Material Name
Batch/ Lot Size
Dispensing start time
Dispensing end time
Cleaning Start time
Cleaning end time