Hemofarm - News - Super Story #5 – Warehouse Operations Service and Quality: Where there’s will, there’s solution, too.

After the SUPER Story On HoloLens and Use Of AR Technology in Hemofarm plants – which has received acclaim from both the colleagues from the company and from the branch as well as from loyal consumers of Hemofarm products, this time the new SUPER Story will reassure us that, in addition to the use of latest technology on the local pharmaceutical market, manufacturing quality remains number one.

SUPER Story #5 comes from Technical Operations, more precisely from the Warehouse Operations Service and Quality Control. Before all, this is a story of quality – quality of people, materials and processes, but also of good organisation of work, responsibility towards environment and consumers, and last but not least of mutual support and collegial spirit within the organisation.

Speaking about quality apparently opens the issue of – how Hemofarm handles non-complying materials?

All the activities in Hemofarm, before all manufacturing activities, are strictly regulated by in-house, state and GMP regulations. In order to have an efficient product, it first has to be of good quality and properly controlled, i.e. in compliance with the specification. If it is not so, the product will not be released to the market at any cost. However, along with the product, raw materials used for its manufacturing, packaging, cartons and foils must not be non-compliant either.

Super priča #5 - Služba skladišnog poslovanja i Kvalitet: Gde ima volje, ima i rešenja.

Super priča #5 - Služba skladišnog poslovanja i Kvalitet: Gde ima volje, ima i rešenja.

‘All the input components go through a strictly defined receipt control. GMP (Good Manufacturing Practice) precisely defines non-compliant materials, their storage and proper destruction. It is of great importance for quality review of our products. There are many reasons why some of materials are assigned the ‘blocked’ status. Most often, it is due to a failure to meet quality standards or due to expired shelf life’, Monika Ostojić, Manager of Warehouse Operations of SEEU Cluster introduced us to the subject matter.

We learn from Monika that all responsible manufacturers have non-compliant materials and that Hemofarm is no exception. As regards of where and how such materials are stored and handled, Monika points out that our company has detailed procedures for handling and storage of these materials. Taking into account that this is a highly regulated industry, consistent adherence to the rules is an imperative for every employee.

‘It happens during the material receipt, i.e. during the receipt control of quality, certain material does not comply with all the required quality standards in order to be used in manufacturing of medicinal products. We receive such a material and put it on stock. Quality Control takes a sample for testing. If the quality of the material is non-complying, the ‘blocked’ status (status ’S’ in SAP) will be assigned to such a material. This means that it cannot be issued for manufacturing or released for sale. Taking into account that we cannot do anything with such a material, we have to transfer it to a special warehouse for non-complying materials as soon as possible. A red label is affixed to each packaging of such material by which we designate it visually that such material is not for use. The same procedure is applied to finished products’, explained Monika.

According to Monika, there are two options depending on the type of non-compliant material.

The first option is to return it to the manufacturer in accordance with the relevant agreement. ‘In this case, up to the moment of its return shipment, the material is stored under defined controlled temperature and humidity conditions, in special cages and in a separate part of the warehouse. In this way we prevent other negative impacts upon the quality of the material and its accidental use’, said Monika.

The second option is proper storage until destruction if we cannot return the material to the manufacturer or if we do not have where to return it. ‘Such material is properly stored in defined pallet places in the warehouse of non-complying materials. This is where it is stored until it is written-off, after which it is transferred to the warehouse of hazardous materials waiting to be destroyed eventually’, added Monika.

Non-complying material is stored in a precisely regulated manner up to the moment when conditions are met for its proper destruction.

Until the moment of its return to the manufacturer or shipment for destruction, the non-compliant material is listed in Hemofarm stock. It is written off only when its shelf life has expired. ‘Before writing-off, we are obliged to inform the republic tax inspector and send him/her the list of materials which we intend to write off. The write-off is approved only when the inspector personally establishes that the shelf life of the material has expired and confirms that the write-off can be performed without additional payment of tax’, explained Monika.

Care for community and environment as an imperative

They say that you can learn a lot about a company by observing how it treats its ‘waste’. We can view most of non-compliant materials as a kind of waste. It is exactly the treatment of such materials, especially if they are hazardous substances, that demonstrates the devotion of Hemofarm to nature, people’s health and sustainable development.

‘Hazardous waste must not be disposed of in municipal landfills by any means. It must be properly destroyed. Until recently, there has been no company in Serbia capable of performing such destruction in accordance with the regulations, so we used to send such types of waste to be destroyed in Austria and Germany. The shipment procedure included first sorting of the waste before shipment and then finding the most efficient method of packaging for shipment. In the end of that road, the hazardous material is safely destroyed’, said Monika, adding: ‘Hemofarm meets all quality standards as regards the treatment of non-complying materials – from the fact that we store it and prevent it from being included in finished products, to the methods of writing-off and its route to proper destruction. Not an inch do we deviate from this.’

What happens when warehousing capacities get full?

Answering this question, people in the company say that instances from the practice have motivated them to consider different alternatives. One of the latest examples of this kind evidently illustrates the cooperation between two sites – the Hemofarm plants in Vršac and in Šabac.

‘Non-compliant materials are non-moving stocks. The problem arises when such stocks increase because this could lead to filling up the storage capacity over 100 percent. This encumbers daily operations significantly, and it often leads to short-term halts in operations’, said Ivan Živanović, Chief of Warehouse Operations in Šabac, pointing out that the very long time period from the moment when material is assigned a ‘blocked’ status to the moment of writing-off presents the greatest challenge.

According to Ivan, in spite of having the huge high-bay warehouse at the Šabac site, non-complying materials just piled up at this site due to a string of events, including the global chain disturbance caused by COVID-19 pandemic during 2020.

‘As a rule, nothing can enter the warehouse before a place is made for it. It is therefore necessary to ‘pull the plug’, said Ivan.

As he pointed out, a solution came up during a regular team meeting. ‘During one of the regular team meetings, we came to the idea to transfer the non-complying material to Vršac. We thought it over, taking into account all the current circumstances and potential risks’, explained Ivan, reminding that standards of pharmaceutical industry are exceptionally high with a good reason. ‘To make sure the standards are fulfilled, we needed to align the transfer together with the Quality Control, to perform the change in SAP – for the blocked material, to prepare a Change Control and perform a risk analysis’, explained Ivan concluding:

‘Joining forces in this one-off action, we have managed to find a way to overcome the current challenge in the condition of limited warehouse capacities. Vršac and Šabac function as a set of communicating vessels. This was not the first time we solved the lack of free pallet spaces with the aid our colleagues from the Warehouse Service in Vršac. Good cooperation, team spirit and understanding are definitely the key pillars of our method of operation.’

Zdravko Srdanović and Ivan Živanović

Quick completion as prerequisite of successful final performance

Zdravko Srdanović, specialist in weighing and warehousing processes, was in charge of the entire organisation of the transfer in Šabac. ‘We completed everything in Šabac within 24 hours after the decision was made. Although organisationally divided on different locations and sites, we from the Warehouse Service have preserved our unity, which is the key to success. ‘, said Zdravko.

The pallets were selected and loaded onto lorries which arrived in the Warehouse of Non-Complying materials in Vršac after a few hours of drive.

‘Every day, we unload hundreds of pallets. Our well-coordinated team completed this task in a few days. Although we get all kinds of requests on a daily basis, we always manage to organise and finish everything on time. This is why our main motto is – finish the job; however, always bear in mind your company first and then your own service’, said Nenad Borojević, chief operative for finished products in Vršac and specialist of warehouse operations, on the occasion of the receipt of the material that arrived from Šabac.

This is a story that, in its own way, reveals the essence of the One STADA company value. It invites the employees to work in the interest of the whole and not their team only, facilitating at the same time the purpose of Hemofarm – caring for people’s health as a trusted partner. The example of the Warehouse Operations and the Quality Control is yet another proof that – where there’s will, there’s a solution, too… and what is very important in pharmaceutical industry – solutions in accordance with regulations.

What is Hemofarm’s SUPER Story?

These are intimate stories about people and teams from our environment, some of which can eventually become company legends.

These are stories of collegiality, courage, sacrifice, responsibility, thoughtfulness, stories we exchange with each other when we want to praise someone, not because it is expected, but because it is deserved.

These are our super stories and as such they deserve to be heard and shared both inside and outside our organization.

If you missed SUPER stories, you can read them here: SUPER Story #1, SUPER Story #2, SUPER Story #3, SUPER Story #4