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Track and trace serialization and aggregation

What is track and trace?

The track trace is a system usually used for tracking postal shipments, shipping packages and objects. It is a tool for tracking the details of shipments. It is a tool that allows you to track the details of your shipments.

In the pharmaceutical sector, a track trace system allows the marking and traceability of medicines. It therefore concerns serialisation and aggregation.

Our track and trace solution

We offer the L.S.M. Label Serialization Management suite.

This track & trace solution allows :

  • Compliance with French, European and international regulatory requirements
  • Compliance with good practices such as Gamp and 21CFR-Part11.

Good automated manufacturing practice (GAMP) is a set of good automated manufacturing practices. As well as being a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE), GAMP includes guidance for manufacturers and users of automated systems in the pharmaceutical industry.

As for 21CFR-Part11, it was created by the FDA (Food and Drug Administration). It defines the rules to be respected when developing IT systems in industry to meet the challenges of traceability of electronic records and signatures.

The Track & Trace features of the Track Trace software

The LSM Label serialization management suite, a set of Track Trace software for the pharmaceutical industry, allows to manage work orders and batches, serial numbers, to print 1D and 2D codes, to control printing, to pilot line equipment.

Other features of the LSM Label Serialization Management Suite

This suite allows a connection to ERP and other external systems. It is available in two specific offers: PHARMACIM LSM, for the pharmaceutical, biotechnological and cosmetic industries; and PRODUCIM LSM for other industries.

Track trace: combating the counterfeiting of medicines and pharmaceutical products

What is counterfeiting?

An infringement is a reproduction or imitation of a literary, artistic or industrial work without the permission of its owner, the rights holder.

It exhaustively affects the different sectors: luxury or textile products, agri-food products, medicines, cosmetics, etc.

Counterfeit products pose a health risk, especially counterfeit medicines which can compromise human safety.

Counterfeit medicines

With regard to counterfeit medicines, the World Health Organisation (WHO) provides an informed definition: “a counterfeit medicine is a medicine that is deliberately and fraudulently labelled to mislead about its identity and/or origin”. This definition is complemented by Directive 2011/62/EU of the European Parliament and of the Council, which states that “a falsified medicinal product is a medicinal product which is misrepresented in several respects such as identity, packaging, labelling, composition, strength of ingredients, source, country of origin, history”.

The role of serialisation and traceability in the fight against counterfeiting

In the pharmaceutical sector, serialisation can be defined as a procedure for identifying medicines and pharmaceutical products. It is complemented and followed by aggregation. One of the objectives of serialisation and pharmaceutical accreditation is to combat the counterfeiting of medicines and health products. In order to effectively combat the counterfeiting of medicines, the Data Matrix is used, which consists of serialising and tracing medicines by batch.

Batch traceability (Data Matrix)

The Datamatrix code is a two-dimensional barcode in rectangular form consisting of dots. It is found on the outer packaging of the medicine. And it has been mandatory in France since January 2011. At each exchange between the parties involved in the medicine, information is saved to enable it to be tracked throughout the pharmaceutical chain: this is the traceability of medicines, including the batch number of the medicine and its expiry date. And the technological device that contains this information is the Data Matrix.

The legal framework for combating counterfeiting

The fight against counterfeiting is a constant priority for the government.

French law, European and international law allow creators and inventors to enforce their intellectual property rights.

Various anti-falsification services exist. These include

  • Customs: customs officers can detain goods suspected of infringing all intellectual property rights.
  • The Directorate-General for Competition, Consumer Affairs and Fraud Control (DGCCRF): they can investigate and establish the offence of trademark infringement as defined by the Intellectual Property Code.
  • Judicial investigations
  • Civil proceedings: Law No. 2007-1544 of 29 October 2007 on combating counterfeiting transposed European Directive 2004/48/EC into French law, in order to strengthen judicial procedures to enforce all intellectual property rights