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 -

FairJourney Biologics enters antibody discovery agreement with Pandion Therapeutics

FairJourney Biologics S.A (FJB) and IONTAS Limited (IONTAS), leaders in the discovery and optimization of VHH and fully human antibodies, have signed an agreement...

Beckman Coulter launch SARS-CoV-2 IgM antibody test in countries accepting CE Mark

Beckman Coulter, a clinical diagnostics leader, has announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The...

95% efficiency for Pfizer & BioNTech’s mRNA-based COVID vaccine candidate

Pfizer and BioNTech’s mRNA-based COVID-19 vaccine candidate – BNT162b2 – has achieved an efficiency rate of 95% after hitting all primary endpoints in a...

BMS completes $13bn MyoKardia acquisition

Bristol Myers Squibb (BMS) has completed its $13.1 billion acquisition of MyoKardia. “We are excited to welcome MyoKardia colleagues to Bristol Myers Squibb,” said BMS...

Samsung Biologics breaks ground on ‘world’s largest’ biopharma manufacturing facility

Samsung Biologics has officially begun construction of its Plant 4 in Incheon, South Korea. Dubbed the “Super Plant”, the new, multi-story 238,000-square-meter construction will be...

Related news

Regeneron’s antibody cocktail granted Emergency Use Authorisation

The FDA has granted Emergency Use Authorisation (EUA) to Regeneron’s antibody cocktail for COVID-19. The cocktail combines casirivimab and imdevimab administered together is the first...

FairJourney Biologics enters antibody discovery agreement with Pandion Therapeutics

FairJourney Biologics S.A (FJB) and IONTAS Limited (IONTAS), leaders in the discovery and optimization of VHH and fully human antibodies, have signed an agreement...

Beckman Coulter launch SARS-CoV-2 IgM antibody test in countries accepting CE Mark

Beckman Coulter, a clinical diagnostics leader, has announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The...

95% efficiency for Pfizer & BioNTech’s mRNA-based COVID vaccine candidate

Pfizer and BioNTech’s mRNA-based COVID-19 vaccine candidate – BNT162b2 – has achieved an efficiency rate of 95% after hitting all primary endpoints in a...