Medicine manufacturers have been working hard with serialisation vendors to comply with requirements under the Falsified Medicines Directive (FMD) of 2011 which specifies safety features for packaging used on medicines. To be compliant individual medicine packs (the lowest saleable unit) must carry a unique identifier (UI) or serial number displayed as human readable text and embedded within a machine readable 2D matrix. The product must also contain anti-tamper evidence. This process alone has proven
Engineering services firm Crest Solutions announces 80 new jobs in 2019 by securing contracts with global Life Sciences manufacturers.
Having successfully competed in the UK regional and national rounds in a series of robotic challenges the school scooped the Teamwork Champion and Design Award, which means Technogear have automatically qualified for the World Championships in Louisville, Kentucky later this month.
For over 20 years, Crest Solutions has helped our customers deliver regulatory compliance and guarantee quality, by providing them bespoke machine vision and serialisation solutions.
If you would like to learn how Crest Solutions helped a pharmaceutical site reduce rework by 1 tonne per day, then register to visit the UKIVA Machine Vision Conference on 16th May, where Phil Dearnaley (Key Account Manager) will present a case study explaining how this was accomplished.
In this case study Phil will:
Describe how to achieve compliance using machine vision integration in a pharmaceutical environment.
Crest Solutions has been named as one of Ireland’s Best Managed companies in the Deloitte Best Managed Companies Awards programme 2018.The company, which demonstrated superior business performance, was recognised at an awards gala dinner in Dublin on 15 March 2018.
An in-depth two phase assessment of Crest Solutions business strategy was completed by Deloitte, being assessed on its ability to develop strategy, demonstrate corporate strengths, excel in their marketplace, retain top talent and manage business risks.
Achieving compliance with EUFMD
During his talk, Dan will share a series of key insights based on the experiences he has witnessed with customers implementing solutions for Serialisation & Aggregation.
From Large Pharma to CMO, Dan has first-hand knowledge of the realities of achieving compliance for regulation on Track & Trace, in particular the EU Falsified Medicines Directive.
Leading safety for pharmaceutical site contracting
Effective in Europe from February 2019, EU directive 2011/62/EU, also referred to as EU FMD, aims to reduce counterfeiting of prescription drugs by tracking and tracing the passage of drugs through the entire supply chain.
Under the Directive, all new packs of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a verifiable unique identifier (serialised code) and an anti-tamper device.