Follow
Objective: To provide a written procedure for handling, storage and dispatch of Finished Products.
Scope: This SOP shall be applicable for Warehouse.
Associated Documents
1. SOP No. IONQA002 Status Label Assignment
2. SOP No. IONQA024 Final Disposition of Rejected Materials, Products and Documents
3. Form No. QA016-01 Quality Assurance Report of Finished Products
Responsibility
1. Warehouse personnel shall be responsible to carry out the activity as per procedure.
2. Warehouse In Charge or his or her nominee shall be accountable to ensure the proper training and implementation of the procedure.
Abbreviations
1. Bulk Product: Any product that has completed all processing stages up to, but not including, final packaging.
2. Finished Product: A medicinal product which has undergone all stages of production, including packaging in its final container.
Precautions: Not applicable.
Procudre
7.1 Transfer to Warehouse
7.1.1 Bulk ION Product
7.1.1.1 The filled bottles of a batch, which could not be packed by packaging section due to their inconvenience or due to any instruction from QA shall be stored in dedicated cabinets as Intermediate under lock and key.
7.1.1.2 Production Officer shall attach “INTERMEDIATE” label to all the cabinets. The labels shall contain the Product Name, Batch No and Mfg. Date.
7.1.1.3 After packaging, the pallets containing the finished products shall be transferred down to the Warehouse in Material Hoist.
7.1.1.4 The Warehouse personnel shall then store the pallets in the QUARANTINE area.
7.1.2 Bulk Infusions Product
7.1.2.1 The autoclaved bottles of a batch, which could not be packed by packaging section due to their inconvenience or due to any instruction from QA shall be stored on pallets as Intermediate.
7.1.2.2 Production Officer shall attach “INTERMEDIATE” label to all the pallets. The labels shall contain the Product Name, Batch No. and Part No.
7.1.2.3 The packaging personnel shall store the pallets in Warehouse in presence of Warehouse personnel.
7.1.2.4 After packaging, the pallets containing the finished products shall be transferred to the Quarantine area.
7.1.3 Finished Product
7.1.3.1 After packaging, Warehouse Personnel shall receive the Finished Products from packaging section having counted the claimed quantity mentioned in the transfer note.
7.1.3.2 Shipping Cartons containing Finished Products shall be palletized.
7.1.3.3 The pallets bearing the “QUARANTINE” label shall be moved to the Quarantine area by a hand trolley and placed on rack by forklift.
7.1.3.4 The Batch No., Quantity of Bottles Transferred etc. shall be recorded in the “RECORD OF FINISHED PRODUCT” log book.
7.1.3.5 Manager, Quality and Head of Quality shall give the final disposition of the Finished Products either approved or rejected in form no. QA016-01.
7.1.3.6 The copy shall be distributed to Warehouse.
7.1.3.7 Manager, Quality/Designee shall issue “RELEASED” or “REJECTED” status label according to SOP No. IONQA002.
7.1.3.8 QA Officer shall ensure affixing proper status label on each pallet and in case of rejected label QA Officer shall affix it himself.
7.1.3.9 The Warehouse personnel shall then transfer the released or rejected Finished Products to the released or rejected areas respectively with proper status label.
7.1.3.10 The rejected Finished Product shall be disposed as per SOP No. IONQA024.
7.1.3.11 The quantity of approved Finished Product shall be entered in the “RECORD OF FINISHED PRODUCT” log book and the balance shall be updated.
7.1.3.12 The approved Finished Product shall be given on the basis of a “FIRST-IN-FIRST-OUT”(FIFO) system.
7.1.3.13 Deviation from this requirement shall be temporary and justified.
7.2 Storage of Finished Product
7.2.1 Finished Product shall be stored off the floor on pallets in racks and, when appropriate, suitably spaced to permit cleaning and inspection.
7.2.2 Finished Product shall be stored under appropriate conditions of temperature and light according to the LIST OF FINISHED PRODUCT STORAGE so that the quality and purity of the products are not affected.
7.2.3 Records shall be maintained of minimum and maximum temperatures once in 24 hours in the TEMPERATURE LOG BOOK (Enclosure 10.1) preferably in the morning as it is critical for the material characteristics
7.2.4 Any status label found to have fallen off the pallet within the Warehouse shall be destroyed and the product stored in unlabelled pallets shall not be used until “Positive Re-identification” has been established. It shall not be used if any doubt regarding the identity of a product arises.
7.3 Transfer to Distribution Department
7.3.1 Distribution Department shall send a memo “Requisition for Finished Product” to Warehouse Personnel for the required quantity of Finished Products.
7.3.2 Warehouse Personnel shall check the availability of the required Finished Products in the “RECORD OF FINISHED PRODUCT”.
7.3.3 If available, the required quantity of Finished Product shall be chosen on FIFO basis for dispatch and the required quantity shall be transferred and stacked in the loading/unloading bay of Warehouse.
7.3.4 Distribution Department shall carry the Finished Products either by their own transport or by hired transport.
7.3.5 In case of own transport, the driver of the carrier shall be handed over a memo for the consignment.
7.3.6 In case of hired transport, the escort of the transport shall be handed over the memo.
7.3.7 The escort is usually an employee of the company and shall be authorized by the Distribution Department for this consignment.
7.3.8 Warehouse Personnel shall file properly the “Requisition for Finished Products” raised by the Distribution Department and Letter of Authority for transportation.
7.3.9 The quantity delivered shall be recorded in the “RECORD OF FINISHED PRODUCT” and the stock position shall also be updated.
7.3.10 The distribution records shall be documented in the Distribution Department and District Depot of BPL. These records are readily available for product recall. These records shall contain information on wholesalers and directly supplied customers.
