spacer
home > pmps > winter 2018 > uncommon codes
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Uncommon Codes

With deadlines approaching in Europe, the US, and other countries, pharmaceutical companies and CMOs on both sides of the Atlantic are scrambling to implement viable serialisation solutions to comply with regulatory requirements, such as the Falsified Medicines Directive and the Drug Supply Chain Security Act.

While a lot of time and resources have already been expended on line-site implementation, connecting the dots with sufficient infrastructure – both at the enterprise level and along the ensuing supply chain – is now critical. Today, serialisation compliance clearly affects aspects of a business far beyond the production line. From manufacturing through to the point of dispensation, great demands exist to exchange information between trading partners and stakeholders to address both regulatory requirements and business challenges.

Ensuring Unique Numbers


The life of a serialised product begins with the generation of a unique serial number. When producing medicines for markets where serial numbers are not created and managed by authorities, the need for generating and exchanging serial numbers depends on a pharma company’s size, structure, and business strategy.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Pavel Lotkov is Product Director for Adents. Formerly with Eli Lilly, Pavel has more than 16 years of information technology experience and possesses a deep understanding of business operations at large pharma companies. As solution implementation and adoption lead, Pavel focused on regulatory requirements and business process analysis, risk impact assessment, system validation, and solution provider management. Pavel was instrumental in providing tactical and strategic support to Lilly’s functional areas impacted by serialisation.
spacer
Pavel Lotkov
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

BioIVT Introduces New Quality Management System to Maintain Highest Quality Biospecimens and Drug Development Research Services

BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it is introducing a new internal cloud-based Quality Management System (QMS), Master Control. This new standardized, ISO compliant QMS will help BioIVT manage documentation, auditing, supplier and customer accounts, and risk across all locations. It will consolidate and replace a variety of computer- and paper-based document control systems located at existing and newly-acquired BioIVT sites in the US, Europe and Asia.
More info >>

White Papers
 
Industry Events

SAPHEX 2018

1-2 November 2018, Gallagher Convention Centre, Midrand, South Africa

The SAPHEX exhibition and conference is now established as the “go-to” networking and business event for anyone working in the South African pharmaceutical manufacturing industry.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement