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 

External Providers 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 QUARANTINEREJECTED 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:

If special conditions are required, they are controlled and recorded 

Products are

8.4 Identification (7.5.8)

8.5 Traceability (7.5.9)

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 

8.9 Returns

8.10 Disposals/ REJECTS

9.  Risk Based Approach

In the event of non compliance follow SOP  NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

[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