Below are the general procedure for good controls and practices for Packaging Activities in Pharmaceuticals and the persons working in packing department should follow the procedure for better control and compliance.
Every person should follow personnel entry and exit procedure for entry and exit in Packing Area as per SOP (Standard Operating Procedure).
Before starting any operation, personal hygiene, product safety and area cleanliness must be checked by the concerned packing personnel.
Entries in BPR (Batch Packing Record) should be done timely and neatly and BPR should be checked for its Batch No., Batch size, Product code, Market, Shelf Life, pack size and Storage condition etc.
Ensure Cleaning and line clearance of machines and area as per respective SOP’s and ensure that the machine setting is done as per respective SOP’s.
Check the release status of bulk/semi-finished product with batch no. Weigh and verify gross weight of each container against the product label on it.
Check the Product name and batch no. on each container and bring it to respective packaging line planned for packing after line clearance.
Always load the containers of the bulk product in the product hopper in serial order/Lot wise and Attach labels of bulk containers in BPR.
Check for product name, strength, count and batch no. on dispensed packaging Material before bringing the material on to the packing line.
Always keep the packing materials of one batch in a cage trolley or in a pallet with required label to avoid mix up with other product or batch.
Remove and verify the dispensed packaging material labels for material code, A.R.No., Dispensed quantity, Batch No., Count against Packaging Material Requisition and Dispensing Record and attach the labels in BPR after verification.
All rejects observed on packing line should be kept in crates / reject bins / poly bags with appropriate status labels and at the end of batch destroy rejects as per SOP .
Persons on packing line should be vigilant and shall perform their activities with full concentration and ensure that there is streamline flow of packs on packing line with appropriate packing controls.
If required provide break to the persons working in packing line .
Packing material rejects found (if any) on the packs should be informed to the line executive/technician and ensure that all the rejected packs are put in the crates.
Ensure that individual carton is checked for proper overprinting quality on it and ensure that a set of cartons per insertion into the shipper (can vary as per the shipper fill value).
Ensure that individual filled shipper is weighed for its fill value and is stacked on the pallet and ensure that if the balance detects short or excess carton on display it should be informed to the line executive and ensure that shipper number and weight is properly written on the shipper.
Initial checks and operating specifications shall be check and record in BPR as per instructions mentioned in BPR.
Reconcile all packaging material after sample quantity written by QA in BPR at the end of batch.
If any excess packaging material is required for the batch, shall be issued from warehouse and Balance packaging materials (if any) are returned to ware house through Packing Material Return Note.
If there is any partially filled shipper in the department at the time of closing, it shall be sealed partially with BOPP tape and It shall be kept on table and It shall be checked by Officer next day morning before starting the line.
End of batch / Partial packing of batch shall be transfer to finished goods warehouse through Packed Goods Transfer Note.
For any breakdown of equipment or maintenance give the intimation to the Engineering Department.
If any cancellation is to be done in any packing document, It should be strike off by a single line and it must be signed with date by concerned person and Overwriting is not permitted in any document.
Any incident or deviation shall be immediately reported to QA by logging it and the same shall be investigated through incident report.
Usage and cleaning logs should be maintained for all the equipment.
Guideline for closing of Blister packing lines during breaks (Tea/Lunch/Dinner):
Ensure that product is not present on the sealing station of machine and the packs are removed from the machine conveyor.
Ensure that hopper and bowl are covered properly and Put off the machine.
Ensure that product fallen down (if any) on the floor are removed and put in rejection bin and ensure that the poly bags containing products are tied or fastened properly.
Put off the conveyor belt and Check the good packs/rejected packs are kept properly in the respective containers and ensure that filled cartons are overprinted.
Ensure that there are no partially filled cartons on the conveyor/table and Put off the lights of the area and Finished goods are transfer to Warehouse as per packed goods transfer note.