Serialisation in pharmaceutical production

In February 2019, serialisation of pharmaceuticals will become mandatory in the European Union. To protect patients against forgery, medicines must be serialized during packaging and fitted with an anti-tampering device.

One of the pioneers in this field is R-Pharm Germany – formerly part of the Pfizer production network. Back in 2009, the experienced CDMO developed systems for serialization and aggregation and went live with several packaging lines in its facility in Illertissen, Germany.

Today, R-Pharm supports manufacturers, which are not ready for the upcoming requirements, by providing packaging capabilities including serialization as a standard service.

In addition, the company shares the relevant organisational and technical expertise in a so-called “Track & Trace User Academy”, a collaboration with Mettler Toledo PCE founded in 2017.

The support by R-pharm is reducing the customer’s ramp-up phase to a minimum. If a customer is not able to establish the necessary equipment and procedures in its own facilities in time, R-Pharm can bridge the gap guaranteeing to meet the deadline.

To avoid the investment in the regulatory-compliant serialization and aggregation systems, customers may also decide to source out the packaging to R-Pharm completely.

The CDMO has many years of experience and is certified in over 150 markets worldwide. Among them are all markets, where regulations about serialization of pharmaceutical products are already effective, like Korea, China, USA, EU and Saudi Arabia. The integration in R-Pharm´s systems including the necessary IT solutions is smart and very convenient for new customers.

“Twelve months is an extremely short time to set-up a proper system and the needed site organization for a serialized and aggregated production,” said Michael Unbehaun, Manager Engineering Site Projects. “If a manufacturer hasn´t started yet with a solid implementation project, it definitely is about time.”

To commission a CDMO with serialisation and aggregation is a possible solution, but even then, it is now time to take action, as capacities might be short soon.

A message from the Editor:

Thank you for reading this story on our news site - please take a moment to read this important message:

As you know, our aim is to bring you, the reader, an editorially led news site but journalism costs money and we rely on advertising and digital revenues to help to support them.

With the Covid-19 lockdown having a major impact on our industry as a whole, the advertising revenues we normally receive, which helps us cover the cost of our journalists and this website, have been drastically affected.

As such we need your help. If you can support our news sites with a small donation of even £1, your generosity will help us weather the storm and continue in our quest to deliver quality journalism.

In the meantime may I wish you the very best.

- Advertisement -

Novavax selects PolyPeptide to manufacture critical component of COVID-19 vaccine

Novavax has selected CDMO PolyPeptide Group to manufacture a critical component of its novel coronavirus vaccine candidate, NVX-CoV2373. NVX-CoV2373 is a stable, prefusion protein made...

COVID-19 could hinder blockchain implementation in pharma supply chains

Even though blockchain stands out as a potential solution to improve pharma supply chains, COVID-19 may become a hindrance rather than a trigger in...

Emergent joins partnership for COVID-19 vaccine development & manufacturing

Emergent BioSolutions has been issued a task order under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA) to deploy its...

Brilinta approved in US to reduce the risk of first heart attack or stroke

AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with...

GSK to manufacture 1bn doses of pandemic vaccine

GlaxoSmithKline (GSK) is aiming to manufacture one billion doses of its pandemic vaccine adjuvant system, in 2021, to support the development of multiple adjuvanted...

Related news

In brief: New head of R&D for Cellbox Solutions

Germany’s Cellbox Solutions has appointed Lonza Pharma and Biotech’s former Head of Biosolutions R&D as its new Head of R&D. Dr Herbert A. Mueller-Hartmann will...

Novavax selects PolyPeptide to manufacture critical component of COVID-19 vaccine

Novavax has selected CDMO PolyPeptide Group to manufacture a critical component of its novel coronavirus vaccine candidate, NVX-CoV2373. NVX-CoV2373 is a stable, prefusion protein made...

COVID-19 could hinder blockchain implementation in pharma supply chains

Even though blockchain stands out as a potential solution to improve pharma supply chains, COVID-19 may become a hindrance rather than a trigger in...

Emergent joins partnership for COVID-19 vaccine development & manufacturing

Emergent BioSolutions has been issued a task order under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA) to deploy its...