Department | Warehouse | Document no | WAR-115 | ||
Title | Storage or Handling Rules for Inventory Items | ||||
Prepared by: |
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| Supersedes: |
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Checked by: |
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Approved by: |
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1.0 DOCUMENT OWNER
Warehouse / Quality Manager
2.0 PURPOSE
To outline procedures / guidelines for storage and handling inventory items in the Warehouse at a GMP site. Non-inventory items and consumables of importance are also covered.
3.0 SCOPE
3.1 Inventory Items in ERP
This SOP covers inventory items located at the GMP site. Inventory items consist of:
– Raw Materials (RM);
– Bulk materials (BM) (also called Semi Finished goods or SFG) e.g. tablets / capsules / pastes / vials / blends);
– Packaging Materials (PM); and
– Finished Goods (FG).
3.2 Inventory Items in ERP system
This SOP covers Finished Goods or Semi-Finished Goods at GMP site.
3.3 Non-Inventory Items
This SOP covers Non- Inventory items held in the warehouse. Non- Inventory items are consumables used in production and associated departments that do not feature in the bills of materials. Examples are pallets, plastic bags, plastic containers, disposable gloves, hot melt glue, adhesive tapes, lubricants, and disposable overalls.
4.0 RESPONSIBILITY
4.1 All areas in the warehouse except the receiving area are temperature controlled. Warehouse Manager and QA investigate all temperature / humidity deviations that have GMP or product quality impact (denoted by GMP alarms) and take corrective actions. (Refer SOP QMS-035 Pharmaceutical Deviation Report System”.)
4.2 RM / API are always stored in warehouse racks at conditions per directions from QA in warehouse racks.
4.3 Where the required storage temperature is between +2 to +8 degrees C, such items are stored in the Warehouse Fridge.
4.4 Semi-Finished Goods (BM) (purchased and manufactured in plant) and Finished Goods in ERP system are stored in racks in the warehouse in appropriate warehouse zones. Recommended storage conditions must always be met. Deviations involving GMP alarms are promptly recorded and investigated. Refer to relevant lists for storage conditions of FG.
4.5 All items entering the clean zone areas shall be placed on site-captive use metal or plastic pallets (e.g. sampling booths, dispensary and in other areas where components of drug products or Semi Finished goods are exposed to the environment in the area during processing activities).
4.6 Not more than one item of RM, API, PM, BM or FG and not more than one lot of any one item may be placed on any single pallet or at a physical location in the warehouse unless separated by a QA approved barrier.
4.7 No item may be stored or placed directly on the warehouse floor.
4.8 All items are placed on pallets and are stored in racks. Operators check the weight of the pallets and the safe loading limits of the racks before they place any pallets in racks.
4.9 For working purposes, pallets with RM, API, PM, BM or FG may be placed on the designated floor areas in the receiving area, in the Finished Goods staging area and in the Packaging Shop order staging area within the warehouse. These floor areas are not to be used for storage of pallets but are used temporarily for working with palletized material (for activities like checking or labelling).
4.10 All stacks empty of wooden pallets should be less than 1.8 m high and no more than 4 such stacks may exist side by side in a given area. Occasionally, empty pallets may be placed in staging areas on the floor. However, empty wooden and plastic pallets may not be stored on the floor for more than 24 hours in a given spot for housekeeping reasons.
4.11 The designated locations for storage of empty wooden pallets are the lower two levels of racks where high-density sprinkler heads are available for fire protection.
4.12 Only fumigated wooden pallets or plastic pallets are used for dispatches to export- markets. Such pallets are stored in the racks in the finished goods staging area.
4.13 Warehouse housekeeping is carried out per SOP MAN-015 Factory Cleaning Procedure”. Warehouse operators promptly pick up discrete articles off the floor to keep the floor clean and safe for forklift operation. Warehouse operators promptly attend to any spill and contact EH&S for advice if required. All waste is placed into marked bins.
4.14 All reject items / lots are moved and isolated in the Reject Cage physically and in ERP system in accordance with SOP WAR-015 Warehouse Processing Issues Return and Rejects”.
4.15 All Quarantine-Hold items / lots are moved and isolated in the Quarantine-Hold Cage physically and in ERP system in accordance with SOP WAR-005 Receipt of Incoming Goods”.
4.16 The reject and Quarantine Hold cages are always kept locked. Warehouse Manager is responsible for controlling the destruction of reject inventory from the reject cage. Appropriate lot disposition and labelling have to be carried out by QA before any Quarantine hold inventory leaves the Quarantine hold cage.
4.17 Retiring / removal / destruction of reject items from the warehouse is carried out in accordance with SOP WAR-015 Warehouse Processing Issues Return and Rejects.
4.18 Miscellaneous (non-inventory) items and Approved List for Lubricants, Cleaning Agents, Oils and Miscellaneous Materials are stored in the inwards goods cage in the receiving area of the warehouse until approved stickers are applied to the materials. Subsequently, they are moved and stored in the dedicated racking for non-inventory items.
4.19 Production Manager / delegate manages the non-inventory items in the warehouse (ordering, storage, issue and inventory control). Non-inventory items are only stored in their dedicated racks in the warehouse.
4.20 All FG and any SFG for sale are held in ERP system under test in appropriate QA status (e.g. Q status).
4.21 All items meant for distribution out of Warehouse are approved and moved from ERP system.
4.22 All FG and SFG are dispatched from the site if they are in Approved status in ERP system. Lots of any item is selected from those available in ERP system for dispatch based on First Expired First Out rule (FEFO) unless a customer specifically requires a given lot. All other deviations to FEFO rule are approved by QA. FG and SFG may be shipped in Quarantine status if authorized by QA in accordance with SOP WAR-020 Dispatch of Goods from Warehouse.
4.23 Any inventory item in ERP system that is sold or dispatched to another affiliate or are sent to a third party contractor against a packaging shop order MUST be in approved status in ERP system.
(Exceptions to this rule are samples being sent for analysis / evaluation or testing and goods being returned to suppliers). Appropriate transactions for sale or transfer or dispensing transactions to shop orders have to be carried out in ERP system before such items are dispatched.
4.24 All items that are dispatched from ERP system are allocated to appropriate orders and Warehouse / other logistics operators shall ensure that all instructions for packaging and labelling and dispatch from the consignee are fully complied with and appropriate invoices are raised.
4.25 All customs rules are implicitly followed whilst exporting from GMP site to overseas destinations and export documents are safe kept in the Logistics Department in accordance with the requirements of the local Customs Service.
4.26 All safety requirements of local regulatory bodies are met and EH&S safety guidelines are followed in the Warehouse.
4.27 All trucks carrying incoming inventory items and all trucks for outgoing Inventory items are inspected by warehouse personnel (after they are checked by site security at the gate). Unloading and loading is carried out only after this inspection.
4.28 All inventory items (FG / SFG) leaving GMP site and bound for the local distribution centre are sent in dedicated trucks on non-stop priority basis to ensure that transport temperatures are the same as the site storage temperatures.
4.29 All export airfreight shipments are sent in covered trucks to local depots of the GLSP (Global Logistics Service Provider or Freight Forwarder). Where specified, data loggers are used to monitor transit temperatures.
4.30 Sea Freight shipments are sent in sealed containers through GLSP. Temperature controlled Reefers are used where temperature control of exported items is required. Logistics department review temperature control requirements with QA in all cases and set the temperatures in accordance with the requirements of the transported products. Temperature mapping and data logging of shipped inventory items will be conducted in accordance with the recommendations of QA.
4.31 All items requiring transportation between +2 and +8 degrees Centigrade are specially packed and shipped in containers to maintain these temperatures. Data loggers are used in all such shipments.
4.32 Inventory items requiring special security provisions are handled appropriately per security policy and where required, sealed aircraft cans and sealed shipping containers / reefers are used.
4.33 The warehouse adheres to any special packaging or palletizing or labelling instructions or documentation from individual customers. Logistics customer service colleagues convey such special instructions from customers to the Warehouse Manager to ensure that such special requirements are met.
5.0 PROCEDURE
5.1 Receipt and book in all inventory items in accordance with SOP WAR-005 Receipt of Incoming Goods.
5.2 Sample all inventory items in accordance with SOPs WAR-085-Sampling and Inspection of Raw and Bulk Materials & WAR-090-Sampling Inspection and Release of Packaging Materials.
5.3 Carry out all transactions for Inventory Items in ERP system that reflect physical transactions in the warehouse (e.g. Sampling, transfers, dispensing / returning to / from Shop orders or sale).
5.4 Store all Inventory items in ERP system in accordance with required storage conditions. Refer to site register for Raw Materials and API.
5.5 FG and SFG items approved in ERP system may be shipped to customers. Carry out transactions in ERP system. Always use FEFO whilst picking approved lots of any item from ERP system (unless a specific lot is requested by a customer). Obtain QA approval before over-riding FEFO rule. Shipping of FG and SFG in Quarantine status is permitted with QA approval in accordance with SOP WAR-020 Dispatch of Goods from Warehouse”.
5.6 Promptly carry out all ERP system transactions for shipments to local distribution centre and all export locations. Ensure all export shipments have correct export documentation (e.g. packing list, commercial invoice, customs clearance, import licenses or certificate of analysis) so that the shipment is not held up in local or overseas at the customs.
5.7 All Export documents are filed and made available for audits by Local Customs. The files are maintained in the Logistics Filing cabinets using shipment reference numbers.
5.8 Carry out reviews of inventory items in stock with QA / Warehouse Manager and re-sample items per QA requirements. Carry out re-sampling of any item coming up for review of Aging Material and per directions provided by the Warehouse Manager.
5.9 Carry out cycle counts, stock takes and inventory adjustments in accordance with guidelines provided by Finance. GMP site managers with appropriate ASL sign off all inventory adjustment forms.
5.10 Warehouse personnel are required to participate in all safety, Quality and Finance / Inventory Audits and promptly carry out action items assigned to individuals / groups. Warehouse is an integral part of GMP site and is continuously audited by Local and internal / external auditors representing site and customers.
5.11 A very high standard of inventory accuracy is maintained through correct and timely transactions in ERP system (required accuracy better than 99%).
5.12 All GMP and Finance and EHS Audit findings shall be addressed through actions within agreed time frames by the Warehouse team.
6.0 DEFINITIONS / ACRONYMS
API Active Pharmaceutical Ingredient
ASL Approved Signature Limit
BM Bulk Material
EH&S Environmental Health & Safety
FEFO First Expired First Out
FG Finished Goods
GLSP Global Logistics Service Provider
GMP Good Manufacturing Practice
ERP Enterprise, Resource & Planning System
PM Packaging Material
QA Quality Assurance
RM Raw Material
SFG Semi-Finished Goods
WAR Warehouse