Serialisation Requirements in the Pharmaceutical Industry

serialisation

Serialisation Requirements in the Pharmaceutical Industry

Supply chains for pharmaceutical manufacturing and medical device production are becoming increasingly complex. Medications, from source to shelf, now involve numerous networks and cross the borders of many different countries around the globe. Serialisation requirements in the pharmaceutical industry have become an important part of  this complex production process.

History of Counterfeit Medicines

The substandard medicines and fake pharmaceutical products represent a significant risk to patients around the globe. WHO reports suggest, counterfeit medications yield over $10 billion annually and result in thousands of deaths*. These medications either don’t work, are contaminated, or do not contain that which is shown on their label.

According to WHO news, from 1 in 10 medications in developing countries have been found to be counterfeit. It has been reported that up to 200,000 children die each year in developing countries, due to fake drugs entering supply chains; and many more adults around the world have also suffered from substandard or counterfeit medications*.

Supply Sources

Up to 35% of medicines in many countries are produced using overseas source material suppliers and/or overseas processing, packaging, labelling or distribution personnel.
The net result of increasingly complex supply chains is an increasing RISK of counterfeit medications being sold to the public, as well as substandard variations of those drugs.

Learn more about global statistics of counterfeit medications in supply chains.

What is Serialisation

Serialisation means the application of a unique random serial number on each saleable unit of pharmaceutical product, which can be traced back to the original source of supply.

Serialisation requirements (Globally)

  • Most countries have increased labelling regulation requirements (GMP requirements for packaging and labelling) to include the concept of serialisation. Countries like the European union, China and South Korea and the U.S. have already regulated the concept of serialisation.
  • Serialisation has been mandated in approximately 80% of countries across the globe, to minimise the risks of fraudulent drugs entering the market.

Serialisation requirements (Australia)

  • Australia is one of the remaining 20% of countries who has yet to fully enforce serialisation regulations to help protect supply chains.
  • It is anticipated that Australia and nearby Asia-Oceania countries will move towards serialisation in the very near future.

Serialisation regulations and impact on pharmaceutical manufacturers

“If you have not yet implemented serialisation of your secondary packaging, you will be ineligible to supply your pharmaceutical products to the countries those who have implemented serialisation regulations.”

How serialisation changes labels on medication

With serialisation, each saleable unit of a product must now contain:

    1. Global Trade Item Number (GTIN)
    2. Serial Number (SN): Unique random serial number
    3. Batch number (BN): E.g., Lot Number
  1. Expiry Date
  2. A unique 2D data matrix code embedded with 4 pieces of information described above, e.g., GTIN, SN, BN and Expiry Date.

serialisation requirements

 

The net result of introducing serialisation into pharmaceutical manufacturing means significant physical changes to production lines, changes the way production operates and increases the complexity of production operation.

Step 1: Source, purchase, install and validate serialisation equipment including 2D capable printers and scanning cameras on each production line.

Step 2: Install and validate secure software system capable of securely uploading and downloading serialisation data from the regulators (e.g. Governments and/or partners) who are managing the serialisation data.

Fundamentally software systems must be enabled to:

  • perform automatic uploads and downloads serialisation data without breaching data security
  • provide flawless integration especially for continuous production lines

FAQs:

1. Who distributes or controls pharmaceutical serialisation numbers?
Serialisation numbers are provided to licenced manufacturers from Government authorities and/or trading partners.

Serialisation numbers must be securely downloaded from the Government agency’s server. Batch process data must be securely uploaded into the same server including secure decommission of unused or rejected serialisation data.

2. How does serialisation protect consumers from counterfeit medications?
There are two (2) key ways that serialisation helps protect the public from counterfeit medications.

The value of serialisation occurs throughout the supply chain. But serialisation is most valuable at the end-point of distribution to actual patients, who are of course the critical focus.

Serialisation benefit #1: Supply chain breaches are more readily recognised and reported. The authenticity of the product can be verified at any point of supply chain by scanning the serialisation data on a saleable unit.

Serialisation benefit #2: The authenticity of the product can be verified at the point of dispensing to the patient by simply scanning the serialisation data on the saleable unit.

3. Does implantation of serialisation to secondary packing have any downsides?
The main drawback of implementation of serialisation is the cost of initial implementation and ongoing running costs.

As an example, each individual production line requiring new equipment can cost upwards of $500,000 AUD. Software and data system integration can also prove costly.

Summary of benefits of serialisation in pharmaceutical manufacturing

  • Compliance with regulations
  • Enables supply to markets where serialisation is mandatory
  • Minimises opportunities for counterfeit drugs to enter supply chains

Got a serialisation problem or project you need managed for serialisation implementation?

If you’re implementing serialisation, the team at PharmOut can help you work through the complexities of reviewing your equipment options, system upgrades and serialisation installations, as well as personnel training/quality assurance system upgrades.

PharmOut’s services include:

  • Complete Project Management of implementation of Serialisation
    • Scoping
    • Equipment/system selection
    • Equipment/software purchase, installation and commissioning
    • GMP documentation
    • Training

We have global experts who can help your organisation no matter which country/countries are involved in your manufacturing and/or distribution processes for your pharmaceutical products.

Contact our team at PharmOut today.