Serialisation Requirements in the Pharmaceutical Industry
Serialisation labelling requirements (serialization) for pharmaceutical products can improve patient safety, prevent counterfeit products from entering the market, and enable more efficient recalls.
Why is serialisation on labelling so important?
Supply chains for pharmaceutical manufacturing and medical device production are becoming increasingly complex.
- Medications move from production (manufacturing source) to shelf (consumers/patients).
- These supply chains involve numerous networks.
- Medicines generally cross the borders of several different countries as they are transported from manufacturing source to shelf (including intermediate processing stages).
- Serialisation labelling strategies are a way to track products using high-tech digital strategies and systems.
- These systems help prevent fraudulent/counterfeit and substandard products from entering the market.
Serialisation can also improve logistics systems and prevent diversions (product theft).
History of Counterfeit Medicines
Substandard medicines and fake pharmaceutical products currently pose a significant risk to public health.
Recent World Health Organisation (WHO) reports suggest that counterfeit medications yield over $10 billion annually (to criminals), and result in thousands of deaths*.
This figure is likely underestimated, as not all deaths or disabilities linked to taking counterfeit medication are properly recorded.
Why are counterfeit medicines a problem?
Firstly, patients are not getting what they think they are getting; especially when they order medicines on unauthorised websites, or are living in low economic regions where there are limited resources for regulatory oversight of pharmaceutical product distribution.
They either don’t work, are contaminated, or do not contain the ingredients shown on their labels.
Example: Counterfeit medications have been found to have inadequate percentages of APIs (or wildly varying amounts) and to be contaminated with bacteria, poisons, and other toxins.
How large is the problem that serialisation labelling is intending to help solve?
Disability and deaths linked to counterfeit medications are a massive problem.
- According to WHO news, from 1 in 10 medications in developing countries (10%) have been found to be counterfeit; some sources report the figure is much higher.
- It has been reported that up to 200,000 children die each year in developing countries due to fake drugs/contaminated drugs entering supply chains.
- Many more adults around the world have also suffered from substandard or counterfeit medications*.
Pharmaceutical tracking systems need serialisation as part of their labelling because many supply chains involve the transport of medicines across different country borders.
- 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 (labelling) for pharmaceutical products?
Serialisation (labelling) 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 updated labelling regulation requirements (GMP requirements for packaging and labelling) to include the concept of serialisation
- Countries like the European Union (EU), 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 that has yet to fully enforce serialisation/labelling regulations to help protect supply chains.
- It is anticipated that Australia and nearby Asia-Oceania countries will move towards serialisation in the 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 that have implemented serialisation regulations.”
How serialisation changes labels on medication
Serialisation Label Example
With serialisation, each saleable unit of a product must now contain:
- Global Trade Item Number (GTIN)
- Serial Number (SN): Unique random serial number
- Batch number (BN): E.g., Lot Number
- Expiry Date
- A unique 2D data matrix code embedded with 4 pieces of information described above; e.g.
- GTIN, SN, BN and Expiry Date.
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 of serialisation data without breaching data security
- provide flawless integration, especially for continuous production lines
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 endpoint 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 movement through the supply chain by scanning the serialisation data on a saleable unit.
Serialisation benefit #2: The product’s authenticity 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 the 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
Implementing a manufacturing serialisation/labelling project you want help with managing?
If you’re implementing labelling changes or other production line updates, the team at PharmOut can help you work through the complexities of reviewing your equipment options, system upgrades and serialisation equipment installations. PharmOut can also provide personnel training/quality assurance system upgrades.
PharmOut’s services include:
- Complete Project Management of the implementation of Serialisation/Labelling procedures
- Equipment/system selection
- Equipment/software purchase, installation and commissioning
- GMP documentation
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.
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