spacer
home > pmps > spring 2018 > supplying success
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Supplying Success

PMPS: The deadlines for the US and European serialisation regulations are getting closer. What should companies be thinking about now to minimise the impact of the enforcement dates on supply?

Erik Haeffler: With the Drug Supply Chain Security Act (DSCSA) now in play and the Falsified Medicines Directive (FMD) deadline just around the corner, it is imperative that companies press ahead with their preparations. Despite the FDA delaying active enforcement of the DSCSA to November 2018, it can still penalise companies for failing to comply. Serialisation has been vastly underestimated by the industry as a whole, hence the DSCSA enforcement delay, so it is important companies effectively utilise the time they have left to ensure the necessary hardware, software, and operational processes are in place.

Additionally, companies need to look beyond their own preparations and consider the levels of preparedness within their supply chain. Those who work with CMOs need to make sure their partners are investing sufficient time and resources into complying. In some cases, they may need to decide whether it will be necessary to switch partners to ensure continuity of supply after the deadlines. Ensuring a robust network of suppliers is in place will allow companies to not only guarantee complete compliance, but also offset the substantial investment required in terms of time, money, and resource.

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
Erik Haeffler is the Vice President of manufacturing services and the Head of CSR at Recipharm. He is responsible for the group’s sustainability work, as well as its focus on operational and commercial excellence. As part of his role, Erik is continuously developing a model for working with multi-site projects and is accountable for operations development across the company, including elements such as project management resources, corporate, and project/product sourcing decisions.

Carlos Machado is Serialization Director at SEA Vision and is responsible for sales, operations, implementation, and post-project support services in the US and Canada. As part of the serialisation initiatives, he is leading the partnership between SEA Vision and Zenith Technologies, implementing its serialisation product suite, focusing on speed to deliver, engineering excellence, and a superior customer experience. In his previous role as Director of Operations at a leading anti-counterfeiting technology provider, Carlos helped to pioneer the serialisation concept and define the future of authentication. He has a wealth of experience in assisting pharma manufacturers with track-and-trace technologies and has worked on more than 75 serialisation projects, from both an operations and delivery perspective.

Dexter Tjoa is Director of Corporate Strategy at Tjoapack. He is responsible for devising, implementing, and evaluating the mid- to long-term strategies of the company and the services it offers, as well as overseeing the commercial, finance, and IT departments within Tjoapack. He has been with the company for two years, during which time he launched Meditraq, one of Tjoapack’s sister brands that offers contract serialisation services. Dexter holds a BSc in mathematics from the University of London, UK, and an MSc in mathematics and computer science from the University of Oxford, UK.
Print this page
Send to a friend
Privacy statement
News and Press Releases

Enjoy form function and comfort with Teknomek’s new class 5 certified PU chair

Teknomek has released a strong, durable and soft PU (poly-urethane) chair designed for use in production, laboratory and healthcare environments. The product is clean room grade 5 certified and can accommodate weights of up to 150 kg.
More info >>

White Papers

Key to Outsourcing Method Development and Validation: A Pragmatic Approach

RSSL

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
More info >>

 
Industry Events

SMI Immuno-Oncology Conference

25-27 September 2018, Copthorne Tara Hotel, London, UK

Immuno-Oncology is a fast-paced field with massive potential to deliver successful and durable cancer therapies, and SMi's Immuno-Oncology Conference will focus on a few key areas of the field with a representation of the whole industry under each area. These areas will be drawn together to look towards the future of Immuno-oncology and how the field can progress.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement