WAREHOUSING, PRESERVATION, IDENTIFICATI0N & TRACEABILITY
1. Purpose
This document provides the process for Warehousing control, preservation, identification and traceability product including medical devices and medicines
This document covers the process for defining the practices that must be followed for handling and storage of finished goods in compliance of ISO13485/ GWP
2. Approval
(Version at end of page)
Signed V28 SC, 07.12.2023 Inclusion of SAH005
3. Scope
The process covers all documents and process and products as defined in the SOP
4. Responsibilities
Approval: Author of the document, Alexi Arhondonis, SCR RP
Changes: Author of the document, Alexi Arhondonis
5. Definitions
Warehouse - a large building where raw materials or manufactured goods may be stored prior to their distribution for sale
Preservation of Product - adequate measures are taken to protect/preserve product during internal processing and delivery to the intended destination
Identification - the action or process of identifying a material or product
Rejected Product - batches of Product or Pipeline Product which are either (i) not in compliance with the applicable Specifications, CGMPs, the Legal Requirements) as a result of the Manufacturing or Warehousing failure or deficiency, or (ii) determined by final decision management not to be suitable for final release or release to market.
Return - sending back to the manufacturer, wholesaler or distributor a pharmaceutical or medical device product, which may or may not present a quality defect;
Quarantine - the status of starting or packaging materials, intermediate, bulk or finished products isolated physically or by other effective means whilst awaiting a decision on their release or refusal;
Rework - the action of redoing a production procedure for an item / batch in order to correct a defective / faulty aspect/s (eg: packaging / labelling / out of specification) mainly in regards to disposable products
Repair - is to restore (something damaged, faulty, or worn) to the original safety and performance condition to put the item back into acceptable working order again
Maintenance - this is required for preserving the condition of an item (infrastructure, machinery, products)
Refurbishment - the process used to return medical devices to a condition of safety and effectiveness comparable to when new and without significantly changing the equipment's performance, safety specification and/or intended use as in its original registration (eg: sharpening scissors)
6. Abbreviations
SHEQ - Safety, Health, Environment and Quality
NCCA – Non Conformance Corrective Action
GMP - Good manufacturing / warehousing / Distribution practices
7. References
ISO13485 Clause 7.5.8, 7.5.9 and 7.5.11
Non-Conformance, Deviations and Concessions & Corrective Action SOP
8. Procedure
8.1 Warehousing
Products are verified and received into the SA Health warehouse, with the exception of NGO Items which are released as per instruction by the NGO refer operations GOODS RECEIVING PROCESS SAH005
1, Receiving of goods and dispatching of goods follow the same entry / exit point but the activities do not happen at the same time .
2. Premises should provide protection for the goods from contamination and deterioration, including protection from excessive local heating or undue exposure to direct sunlight. The goods received or dispatched at receiving or dispatch bays, docks, platforms or areas should be protected from dust, dirt and rain.
3. Premises are kept free of rodents, vermin, birds, pets and pests. refer Cleanliness SOP
4. Premises have dedicated and demarcated areas available for the receipt of stock, general storage area, goods in QUARANTINE, REJECTED goods, cold-chain storage (not applicable), RETURN good and dispatch goods. Areas are labelled for BOTH the medical device and Medicines (Pharmacy ) areas
Diagram of Premises refer INFRASTRUCTURE
5. All packaging for stored, receipt or dispatch stock should be carefully inspected for tampering, contamination and damage and if necessary the suspected container of the entire delivery should be quarantined or set aside for further investigation.
6, Goods returned or found to be damaged are stored in the QUARANTINE area, after being logged on the QUARANTINE stock list, and separated by colour tape with YELLOW for returned goods waiting decision and RED tape for damaged goods/ returns.
8.2 Temperature Controlled Areas
Temperatures should be controlled and monitored using calibrated monitoring devices.
For medicines and temperature sensitive medical devices; monitoring is conducted at points representing the extremes of the temperature range (hot spots or cold spots) based on temperature mapping with recorded temperature monitoring data available for review.
The equipment used for monitoring should be checked at suitable intervals and the results of such checks should be recorded.
Monitoring equipment should be calibrated once a year and air-conditioners maintained refer SOP Infrastructure & Environment
All monitoring records should be kept for at least the shelf-life of the stored pharmaceutical products plus one year.
(Files for the Work Instruction for Data Logging)
8.3 Preservation of Product (7.5.11)
The organization followed the procedure for preserving the conformity of product to requirements during processing, storage, handling, and distribution.
Preservation applies to the constituent parts of a medical devices and medicines.
The organization protects product from alteration, contamination or damage when exposed to expected conditions and hazards during processing, storage, handling, and distribution by:
designing and constructing suitable packaging and shipping containers;
documenting requirements for special conditions needed if packaging alone cannot provide preservation.
If special conditions are required, they are controlled and recorded
Products and their component parts are protected and preserved at all stages from receipt to delivery in order to maintain conformity to requirements.
The products are stored in designated areas.
Inward receipts and outward releases are controlled.
Products in storage are assessed periodically to detect deterioration
All packaging is designed and quality checked to preserve and ensure product quality
Protection of the product during delivery to the customer is confirmed with vehicle
Products are;
Identified by code and description, printed on the boxes by the manufacturers
Handled by staff to ensure no damages
Packaged into delivery boxes and labelled to ensure that the integrity of the products are not compromised during transportation
Stored in bin locations and on racks
Protected within the storage facility
8.4 Identification (7.5.8)
Products are labelled by the manufacturer; All labels and containers should not be altered, tampered or changed. The legislation relating to labels and containers should be adhered to at all times
The product STATUS with respect to monitoring and measurement requirements throughout product realization is not identified as all product stored and processed are released by the principal and verified on receipt as per Purchasing SOP for External providers
The Warehouse has controlled flow to separate goods receipt for verification before stocking and storage and ready for pick and pack when orders received; Identification of product STATUS is therefore maintained throughout acquisition, storage, installation and servicing of product to ensure that only product that has passed the required inspections and tests or released under an authorized concession is dispatched, used or installed.
If required by applicable regulatory requirements, the organization shall document a system to assign unique device identification to the medical device.
Any medical devices RETURNED to the organization are identified and distinguished from conforming product by location in a secure location until disposition is decided
8.5 Traceability (7.5.9)
The organization provides for traceability of products; Traceability is in accordance with applicable regulatory requirements. Records of traceability are kept digitally refer SA Health process number SAH020./ SAH020A
INCOMING GOODS (IMPORTS/ LOCAL and RETURNS): The batch or serial number are recorded on the Warehouse Management System where the Batch or Serial numbers are inputted to the system when the receipt is logged, the receipt creates a Tracking number, which follows the product through the process.
OUTGOING (SALES / DISTRIBUTION) - When a product is picked, by the warehouse staff, from the picking slip the Batch / Lot number and expiry date is recorded through scanning. The Tracking number is logged against all invoices and delivery notes by the Warehouse Management System.
In the event of a power failure, and or Wi-Fi issues the following back up plan will be put in place.
Warehouse process will revert to a manual process.
Any Receiving documentation will be kept with the Warehouse Manager for reference when system is back up and running.
Any Picking / Delivery will be recorded and all records kept by the Warehouse manager for reference when system is back up and running.
The Tracking number is shown on the product labels and can be used on the invoice documents.
If product has not been captured onto the system, then the Batch/Serial, and Expiry Dates can be used instead of the Tracking (T) number.
After system is back up and running the Warehouse Manager must ensure that all warehouse activities are entered into the system.
8.6 Stock Rotation
To ensure effective stock rotation of products due to expire first must be sold and/or distributed in accordance with the first expiry, first out (FEFO) principles. Where no expiry dates exist for the products, the first in, first out (FIFO) principle should be applied. This is validated in the Granite stock management programme.
All stock is be checked regularly for obsolete and short dated stock items. All due precaution is be observed to prevent the issue of such short dated or expired stock.
Products with broken seals, damaged packaging or suspected of possible tampering/ contamination are quarantined and not sold or supplied and therefore segregated pending an investigation and decision.
8.7 Incoming and out going goods
The receiving personnel must do spot checks on the vehicles delivering products and dispatching stock and inspect the vehicles for the following: using the VERIFICATION FORM :
a) That the products were protected from light and rain, i.e. the delivery truck has a closed canopy;
b) Products bearing an expiry date are not to be received or supplied after their expiry date.
c) The delivery truck does not have evidence of spillage inside that could lead to possible contamination or have been exposed to anything that can cause contamination to the products, e.g. any hazardous substances etc
d) The delivery truck is lockable to secure the products delivered;
e) The products are not mixed with other materials that will compromise the integrity of the products delivered.
Verification Reports are recorded on the DRIVE - Operation Folder
8.8 Vehicles
Vehicles used to move, store or handle products should be suitable for their use to prevent exposure of products to conditions that could affect their stability and packaging integrity.
Vehicles are loaded and packed correctly to prevent movement and breakages and preferably on a First In, Last Out (FILO) basis.
The vehicles must:
Be clean and free from contamination of rats, vermin, birds, fungi etc;
Have solid sides;
Not transport non products which could result in contamination. e.g. "Medical - from PIC GMP - it means no groceries, food, chemicals etc"
Vehicles should be of sufficient capacity to allow orderly storage of the various categories of products during transportation.
Where special storage conditions (e.g. temperature and/or relative humidity) different from the expected environmental conditions are required during transit these are provided, checked and monitored and recorded.
Mechanisms should be available to allow for the segregation during transit of rejected, recalled and returned products as well as those suspected being counterfeits. Such goods to be securely packaged, clearly labelled, and be accompanied by appropriate supporting documentation.
Measures should be in place to prevent unauthorized persons from entering and/or tampering with vehicles, as well as to prevent the theft or misappropriation thereof of the products.
Where third-party carriers are used, wholesalers/distributors should develop written agreements with carriers to ensure that appropriate measures are taken to safeguard products, including maintaining appropriate documentation and records
In the event of non-conformance then the procedure Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed
8.9 Returns
Returns follow procedure in SOP Sales, Customer Related Processes and Returns refer Returns Process Flow.
Products should not be returned without the necessary and relevant documentation and should not be returned in non-protective and original packaging
Goods returned / due to be rejected are handled in a procedurally correct manner with reasons for returns determined and any further actions followed through and recorded.
All returned and rejected products must be clearly labelled, sealed and stored separately in a secure manner in a clearly marked designated area, Refer above 8.1.6 QUARANTINE AREA
The final decision, after evaluation, to return the goods to stock or destroy any rejected goods and in the event of non-conformance then the procedure Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed
8.10 Disposals/ REJECTS
Products, materials and items disposed from returns, rejects, stock expired or damaged must be disposed by a certified or acceptable disposal facility that can provide a "disposal certificate" to verify the quantity, lot or batch and description of the products, materials or items as evidence of disposal.
the "disposal certificate" must be recorded and filed with the supplier documentation, which can be stored and located with SARS purchasing documentation requirements.
9. Risk Based Approach
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document]
9.1 Trend Analysis and Continual Improvement
The analytical reviews of internal audits, and any other quality related matters, are reported to management and as part of the input from Data Analysis to management review
The Trend Analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.
10. Revision History
Revision 28, 17.12.2023 - SC, Inclusion of 8.1 SAH005 process
Revision 27; 09.03.2023- SCR, inclusion of 8.6 Stock Rotation
Revision 26; 25.08.2022 - AA, inclusion of point 8.1.6 to separate good and non conforming quarantine stock
Revision 25; 15.03.2022 - AA, 27.05.2022 SCR RP - inclusion of medicines temperature requirements
Revision 24; 19.08.2021 - AA - updating 8.1 information and addition of 4 new definitions
Revision 23; 01.07.2021 - TNA - updating responsibilities
Revision 22; 03.05.2021 - AA Approved
Revision 21, 28.04.2021 - TNA - New format with approval / Scope / Responsibilities, Risk based approach and Records and revision history added and new google site format. Amending links and forms.
Revision 20, Digitally signed on 07.12.2020 by TNA
Revision 1-19, unknown due to google site change to new google site
11. Records
Name Retained by/ in Retention period Hard copies Destroyed by
Traceability by Financial documents Bookkeeper 5 years Bookkeeper
Verification Report records Financial Manager 5 years Bookkeeper