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Aggregation, the future of traceability in the pharmaceutical industry.

Pharmaceutical aggregation is the next logical step after the implementation of serialisation. These are two closely related processes. By definition, aggregation connects unique serialised unit packages of prescription drugs to a higher level of collective packages and then to a pallet level giving them a unique serial number. Products with serial numbers are placed in the aggregation process into a larger collective package (kits, cartons, pallets).

In the collective package, each package always has its own unique serial number but also the entire package and pallet has a label containing unique serial numbers. To sum up, this is the process of creating a hierarchical relationship between the unique identifiers assigned to the bulk packages.

Many companies that have completed the implementation of product serialisation envisage aggregation as the next step. It offers new opportunities in the process of tracking drugs through the supply chain. By adopting these solutions, pharmaceutical companies are achieving significant savings. It is also inherently linked to the modernisation of the manufacturing process. Today, many pharmaceutical companies see this solution as a key advantage for the operation of their own business.

Among the many benefits of implementing aggregation are:

- easier management of the production process,

- optimisation of the process of finding specific products for wholesale supply,

- improvement of the control process,

- access to all detailed data,

- facilitating the process of exporting and importing medicinal products,

- simplifying the process of withdrawing specific batches of products.

Aggregation allows for radical time savings. It eliminates the need to open each batch or package in order to scan a single product. All data is easily accessible in the supply chain. This makes it easy to track the products in each transaction. This has a positive impact on the efficiency of the distribution process and, consequently, on the safety and reliability of the processes.

The aggregation process is not obligatory. Currently, no legislation, either in Western Europe or America, orders the use of aggregation data. However, it is a recommended action because of the benefits mentioned and also because it strengthens the integrity of the supply chain. It is anticipated that more and more countries will need to adopt aggregation as part of their national drug circulation legislation. 

It is worth noting that the introduction of new solutions also poses significant challenges. Particularly noteworthy here are, of course, issues related to software and new hardware. Differences in the packaging methodology itself will also be of great importance. Producers will also have to implement new procedures for responding to various unprecedented situations.

There are only a few companies on the Polish market offering professional solutions that can meet the requirements in the pharmaceutical industry. We are pleased that in the coming months, we will also implement a solution to aggregate serialisation data. This will enable us to offer customers a new service that will speed up logistics processes and improve the control of the medicinal product in the distribution chain. We will provide you with more information shortly.

ABOUT US

ABOUT US

Prespack offers specialised services of contract packing, repacking and serialisation for EU-originating medicinal products, psychotropic substances and products that require cold chain storage.

 

We provide our services based on a manufacturing authorization for medicinal products and a GMP certificate from the Polish Chief Pharmaceutical Inspector. We offer serialization solutions to marketing authorization holders (MAHs), including those involved in parallel importation (PI MAHs).

Usługi

OUR SERVICES

Prespack offers contract services to pharmaceutical companies, including packing, repacking medicinal products into individual packs, and serialisation. We provide our services pursuant to a manufacturing and import authorisation and a GMP certificate. We carry out the following operations as part of our manufacturing process:

SERIALISATION

SERIALISATION

9 February 2019 saw the entry into force in Poland of Commission Delegated Regulation (EU) 2016/161 which requires medicinal product manufacturers to use certain safety features on their products. This posed a serious challenge to pharmaceutical and contract manufacturers who had to bring their manufacturing processes and their technical and computer infrastructure in line with the new regulatory standards.

PRODUCTION OF PACKAGING MATERIALS

PRODUCTION OF PACKAGING MATERIALS

We can offer an added value to marketing authorisation holders (MAHs), including those involved in parallel importation (PI MAHs). Our in-house printing facilities are an additional advantage in that we can offer end-to-end production services for packaging materials, including internal logistics and subsequent customising processes.

QUALITY POLICY

QUALITY POLICY

All our manufacturing operations are carried out based on the current GMP guidelines. With our state-of-the-art technology and the Quality Assurance System, we can guarantee product safety and competitive service. We commit all our efforts and resources to make sure that our clients’ final products are as expected by them and fully compatible with Directive 2011/62/EU.

CAREER

CAREER

We are a fast growing business and we are open to new challenges. This makes us the perfect place to build and develop your career at. Choose a job that is full of challenges and will let you step up your skills and qualifications. We create quality in the workplace and we carry out our work with enthusiasm and commitment.

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CONTACT

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Prespack sp. z o.o. 
Sadowa 38 
60-185 Skórzewo

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Phone: +48 61 839 24 75
Office: +48 606 841 900
Customer service: +48 517 344 350
Warehouse: +48 603 292 499+48 604 802 929

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NIP: 7812016420
REGON: 387877393
KRS: 0000877047
E-mail: office@prespack.pl

Wysokość kapitału zakładowego: 360 000,00 zł, Sąd Rejonowy Poznań – Nowe Miasto i Wilda w Poznaniu, VIII Wydział Gospodarczy Krajowego Rejestru Sądowego