System for labeling and control of medicinal products

G.V.Pharma, a.s.

Location: Hlohovec, Slovenská Ľupča, Slovensko

Function: Manufacture of penicillin-type pharmaceuticals

The Slovenská Ľupča Plant produces its own products containing the potassium salt of phenoxymethylpenicillin and products for contractual partners with the provision of storage of raw materials and packaging material, input control, inter-operational, output control, production, adjustment and release of products containing antibiotics in and storage areas.

Implemented products: Pharma Track&Trace

Background:

Prior to 2019, the risk of medicine falsifications increased worldwide. As a result, the European Union has set out in Directive 2011/62 / EU a set of measures to to fight medicine falsifications and ensure that medicines are safe and that the trade in medicines is rigorously controlled.

The European Organization for the Validation of Medicines (EMVO) has taken responsibility for progress in setting up the European Medicines Validation System (EMVS). G.V.Pharma, a.s. already in 2017, the selection of a supplier of a system for labeling and control of medicinal products with a link to the European databank (EMVS) was launched.

Requirements:

Labeling of drug packages with a data matrix code containing a unique serial number - serialization
Ensuring anti-tampering packaging by gluing
The system is intended to ensure that the 2nd, 3rd and 4th level of the data matrix marked with a code for the purpose of "track and trace"
Checking the correctness and legibility of the marking and checking the gluing
Evidence of all packaging of manufactured drugs
Evidence of disposal, inclusion of packaging and transfer of packaging to the laboratory
Report of produced and discarded packages
Approval of the list of packages produced for dispatch
Sending data to the central European database
Possibility of packaging for external customers and import of serial numbers of external customers
Export of used serial numbers for external customers

Our tailored solution:

Project was realised in 2019 for the company G.V.Pharma, a.s., that from February 9, 2019 legislative conditions were imposed on pharmaceutical manufacturers.

Serialization system components:

Automated production line
Industrial code printers
Industrial and handheld scanners
Control PLC with HMI console
Operator PC
Handheld terminal / scanner
Communication interfaces

Key features:

Generating numbers for drug packages according to EU standards
Verification of numbers on packages
Possibility of automatic and manual marking of packaging
Evidence of produced packages
Export to external customer applications

Communication line No.1.:

delivery of generated codes level 1 for the printer
obtaining information if the marked product has been validated as bad or good

Communication line No.2.:

obtaining information of the entering of the package level 1 into the group package
delivery of generated codes level 2 for the printer
obtaining information about the output of the package level 2 from the group package

Communication line No.3.:

obtaining information about the entering of the package levels 1 and 2 into a cartboard package
delivery of generated codes level 3 for the printer
obtaining information of the output of the 3rd level package from the cardboard package

Communication line No.4.:

obtaining information of the entering of packaging level 3 into the pallet packaging
delivery of generated codes level 4 for the printer
obtaining information on the output of packaging level 4 from the pallet packaging

Handheld scanner with touch screen:

for administrative tasks (for example sampling in the lab)

Results:

Thanks to the deployment of our drug serialization system, G.V.Pharma is currently able to label and register approximately 20,000 to 30,000 drug packages per month in the EU HUB.

After the successful implementation of the Track & Trace system - Serialization of drugs, we plan to expand the functionality by: