At Nekicesa we continue to detail every single step of the European Directive to prevent medicine falsification and its usage in pharmaceutical packaging. In our previous post, we advised on how to adapt the artwork prep to serialization procedures.
In this post, we will address codes, its generation and file transfer in the case of externalized code printing.
Who should generate the codes?
According to the Directive, the manufacturer or the commercial license owner is the only responsible for the code generation and for its upload to the national archive.
How unique identifiers or codes should be?
Unique identifiers should have a symbol and a data structure created according to DataMatrix GS1 standards. The Directive 62/2011 establishes that this code (unique ID) will be placed on the medicine’s packaging and it should comply with the following technical specifications:
a) The unique identifier will consist of a numerical or alphanumeric character sequence, exclusive for each medicine folding carton.
b) The unique identifier should contain the following elements:
- – A code (“product code”) that allows identifying at least a name, common designation, dosage form, dose, size and kind of packaging containing the unique identifier.
- – Numeric or alphanumeric sequence (“serial number”) of 20 characters maximum generated by a determinist or non-determinist randomization algorithm.
- – Batch number.
- – Date of expiry.
c) The probability of guessing the serial number will be inconsiderable and, in any case, lower than 1 out of 10.000.
d) The sequence of characters resulting of combining a product code with a serial number will be exclusive for every medication packaging until, at least, a year after its expiration date, or, according to the article 51, section 3, from the Directive 2001/83/CE, until five years after the medication has been commercially available (if this period is longer).
Recommendations for a correct code and database management
Once the codes that will be printed on the medicine packagings are generated, they will be placed on a database. In order to manage and track the identifiers properly, we recommend:
- – To establish a correlation procedure between the database and folding cartons purchase order or production batch. For example, to name the database with the batch identifier number.
- – In case of using DataMatrix GS1 symbology, it is recommended to use a head with standard names:
Example of header data using a “;” separation: GS1.DM;GTIN;EXP;LOT;SN
GS1.DM, indicating the field that will be symbolized with DataMatrix
GTIN; indicating the field containing the GTIN information.
EXP; indicating the field containing the date of expiry.
LOT; indicating the field containing the batch information.
SN; indicating the field containing the serial number
- – The database format admitted by nearly all serialization providers is *.csv (using as a divider “,” or another character as “;”)
- – It is important to take into account the number of registers on the database. They should be enough to cover the folding cartons purchase order or the production batch, including tolerances and drops in production.
The method used for file transfer, for codes that will be printed outside the laboratory or by a non-titular of the market authorization, should be selected by the medicine owner and it should assure the integrity and security of the data provided. Generally, the file transfer is held using secure exchanging platforms.
In addition to this, Directive 62/2011 establishes that “the manufacturer that places security devices will keep registers of all operations made with or over the unique identifier of the medication packaging for, at least, a year after its expiration date, or according to the article 51, section 3, from Directive 2001/83/CE, until five years after the medication had been commercially available (if this period is longer) and will provide them to the competent authorities if required.”
With this information about the creation and codes file transfer, we complete the second part of the serialization process. In our next post, we will focus on the packaging code printing procedure.