On 22 November, our Dutch QbD office in Breda hosted the ISPE Project Management Community of Practice (COP). This time, the COP discussed the challenges the pharmaceutical industry faces concerning the serialisation of products to tackle counterfeit medicines. QbD’s very own Thomas Spanjers opened the session, after which several project managers gave presentations about their serialisation challenges. The presentations as well as the host were met with great enthusiasm!
We look forward to future ways of working together with the Project Management COP!
To understand best practices and approaches of serialisation it is important to trace the origin of the need for serialisation within the pharmaceutical industry. The Falsified Medicines Directive (FMD) published and adopted by the EU was implemented to fight falsified medicines. The need for this directive is high. Both Interpol and the WHO estimate that more than 1 million people die each year due to counterfeit medicines. Serialisation based on the FMD prevents fake medicinal products from causing harm by increasing the transparency and traceability of products. Track and Trace systems serve the industry by reducing the risk of fraud, facilitating investigation of suspect products and aiding in flexible labelling.
Summarising the presentations leads to the following advice when it comes to serialisation on site:
- Form a local serialisation project team with as many of your own staff members as possible to build a track record and preserve knowledge for future projects.
- It is recommended to work with stand-alone solutions and to avoid moving platform where printing and camera systems are used.
- Start the serialisation process in one country and then implement in other countries taking ‘lessons learned’ into account.
- Work closely with customers to explore the use of the new platforms and data
- Carefully select suppliers based on their experience in GMP and audit their quality systems regularly with a focus on document and software version control.