Author: Admin

30/01/2018

GDP and WDA in the UK – Our Latest Article in PMPS

Whilst GDP compliance is becoming increasingly recognised within the Pharmaceutical industry, there remains a lot of confusion over exactly what it entails and which parts apply to each section of the supply chain. Which is why we wrote an article for the February edition of Pharmaceutical Manufacturing and Packing Sourcer (PMPS) magazine, exploring GDP compliance in more depth.

Within the article we focus specifically on WDA licenses, including what they are and who might need one. You can read a copy of the full article here, which is taken from Pharmaceutical Manufacturing and Packing Sourcer February 2018, pages 22-25. © Samedan Ltd

23/01/2018

Introducing our New Associate – Tom Cochrane

We are pleased to welcome a new associate to our team this year – Tom Cochrane.

Tom has extensive experience within the Pharmaceutical industry, with a particular interest in developing and implementing systems that protect products from damage and theft throughout the supply chain.

“It is great to be reunited with Henry and to be joining the ASC team at this exciting time. I worked with Henry for many years and know the expertise that both he and Amy bring to the pharmaceutical industry” said Tom Cochrane.

Amy Shortman said “We are immensely excited with the addition of Tom to ASC. He brings with him over 37 years’ of experience within Quality Assurance, Business Process Improvement and, most recently, Pharma Global Security Operations. Tom’s expertise will add significant value to our clients.”

Find out more about Tom’s experiences on Our Team Page.

11/01/2018

IQPC TEMPERATURE CONTROLLED LOGISTICS CONFERENCE 2018

We are delighted to announce that ASC will once again be presenting at this year’s Temperature Controlled Logistics Conference. Now in its 17th year, the conference is organised by the International Quality and Productivity Center (IQPC), and will run from 29th January to the 1st February in London.

The conference brings together experts from across the industry, covering every aspect of cool chain logistics. With 60 expert speakers, covering 40 sessions split into three distinct streams – planning, transportation, and last mile distribution – alongside 60 exhibitors and 72 hours for networking, it is a key event of the year.

You may remember that last year our CEO, Amy Shortman, chaired the conference. It was a fascinating experience, because it showed us just how much time, effort, and planning goes into making sure the event runs without a hitch. This year we are looking forward to simply enjoying the atmosphere and networking with our fellow delegates.

That’s not to say we won’t be busy. Amy and our COO, Henry Moran, are running a session entitled, “Implementing Global Operation Centres (GOC) and Quality Management Systems (QMS).” We shall be looking at case studies which examine the challenges involved in implementing a global CMS and how these may be overcome.

We look forward to seeing you at the conference.

22/11/2017

Virgin Atlantic Cargo Launches Pharma Zone

On 2nd October 2017, Virgin Atlantic Cargo opened their new Pharma Zone at their facility at London Heathrow. The purpose of the Pharma Zone is to provide a fully segregated area for the handling and storage of temperature-sensitive pharmaceutical products.

As the volume of pharmaceutical products being transported via air freight increases, airlines are becoming increasingly aware of the need to comply to strict regulations and guidelines to ensure that product safety and efficacy is maintained throughout transit. The Pharma Zone has been developed in conjunction with Delta Cargo, and alongside this development Virgin Atlantic Cargo are in the process of applying for a Wholesale Dealer Authorisation (WDA).

Our Work with Virgin Atlantic Cargo

ASC has been working with Virgin Atlantic Cargo over the past 18 months in order to assist in their work towards compliance and application for a WDA. Our work with Virgin Atlantic Cargo began by conducting the ‘ASC GDP Health Check’ on Virgin’s cargo operation and that of their Ground Handling Agents at London Heathrow, the Virgin Atlantic Cargo Hub, and Manchester. This was a thorough audit against EU Good Distribution Practice (GDP) Guidelines and Supply Chain Security.

Virgin then took the findings and conducted a CAPA plan to close the non-compliances. As part of the project, ASC has trained 60 key personal on our bespoke certified (GDP) training course which is designed for logisticians by logisticians. Whilst many other GDP courses focus on wholesale activities, we have developed a course that demonstrates how GDP is applicable in pharmaceutical logistics.

Feedback from our work with Virgin Atlantic Cargo

Rich Ellis (Manager, Products and Partnerships at Virgin Atlantic Cargo) gave us his feedback following the completion of our work with the team:

“ASC’s expert guidance has been invaluable in terms of performing a complete GDP Gap Analysis, and then providing assistance in working through this in our work towards obtaining a WDA. The training provided to staff from various departments has been excellent, and their flexibility allowed us to work with them to design a training program that was suitable to our needs.”

Henry Moran, Chief Operating Officer at ASC, was our project lead and has been working with Virgin Atlantic Cargo for the past 18 months:

Working with the Virgin Atlantic Cargo team on this project was a privilege. Their enthusiasm and passion to learn was second to none, which when combined with their excellent service offerings, made this project a complete success.

We are proud of the work we have done with Virgin Atlantic Cargo, and we look forward to continuing to support the team and to see their products and services to the Healthcare industry develop and prosper.

find out more about the pharma zone

The Pharma Zone has been created with the needs of temperature sensitive shipments in mind, and this is clear to see in the range of features integrated into its design. To find out more about the Pharma Zone, visit the Virgin Atlantic Cargo website, where all the key features of the facility are listed.

02/11/2017

Amy Shortman Becomes Fellow of CILT

Over the summer, ASC’s CEO Amy Shortman was accepted as a Fellow of the Chartered Institute of Logistics and Transport (FCILT). Chartered Fellows are highly respected within the industry, as this is the highest level of membership offered by the Institute and is only available to professionals who have been working in senior roles for at least 7 years.

Amy has over 20 years’ experience within the logistics industry. Her passion for delivering training and guidance to ensure compliance and best practise within the pharmaceutical logistics industry led to the founding of ASC in 2011, which now works with organisations across the globe. So it is wonderful to see Amy receiving this kind of recognition for her work and dedication to the industry.

You can read more about the FCILT and see Amy’s election as a Chartered Fellow in the November issues of Focus Magazine (image below from page 69 of the digital version).

22/05/2017

Outsourcing Article published in PMPS May Edition

Earlier this year we wrote an article on outsourcing for the May edition of the Pharmaceutical Manufacturing and Packing Sourcer (PMPS) magazine. This is something that we are very passionate about, as we believe that outsourcing in key areas such as compliance can significantly reduce costs whilst increasing the efficiency and integrity of the entire supply chain.

You can read a copy of the full article here, which is taken from Pharmaceutical Manufacturing and Packing Sourcer May 2017, pages 19 – 23. © Samedan Ltd

15/05/2017

Thoughts on the PCSC Conference 2017

Well what can I say? Another year passes and another PCSC conference delivers (again). Honestly, this educational conference gets better and better every time. The PCSC is a non-profit organisation made up of all the stakeholders in the Pharmaceutical Supply Chain. Its key goal is preventing theft of pharmaceuticals product whilst in transit.

This year’s conference was hosted by Novartis at their beautiful East Hanover site, New Jersey, and was chaired by PCSC Chairman and industry guru Chuck Forsaith. Chuck put together a stellar programme of presentations that encapsulated why this event is so well respected within the industry. With over 300 professionals in attendance, this event excels over and above any other is its open, honest and challenging discussion.

The standards were high with regards to presenters, however there are no titles on name badges, and there’s absolutely no “speaker” hierarchy; at this conference everyone’s knowledge and experience is valued equally. The warmth and openness that Chuck himself portrays was evident in those he selected to share information, and the strict codes of conduct that prohibit solicitation or selling meant that everyone felt at ease.

The focus of the entire event is on sharing insight and expertise, and we had passionate presentations from all four corners of the globe, with a strong theme of the public/private partnership joining forces to reduce theft within the Pharmaceutical Industry.

ASC were privileged to be asked to present at the conference, and our presentation was warmly received. We highlighted the similarities between GDP and Supply Chain Security, providing insight into how the EU, America, and the rest of the world implement GDP and security practices. Amy Shortman, CEO of ASC says:

“the focus within the US is predominately within Supply Chain Security, whereas the EU has been focusing on Temperature. Both of these are covered within GDP, and so creating a global standard that includes all aspects required to keep products safe and effective is important”.

A shout out must go to Chuck and Carmen who organise, administer, and execute the event without even breaking a sweat! We’re already looking forward to 2018….

03/05/2017

GDP Training with Virgin Atlantic Cargo

Continuing our support with Virgin Atlantic Cargo on development of their Lifesciences Vertical, we have recently been focusing on providing in-depth training on the GDP Guidelines. So far, 47 staff from several departments have completed our Certificated One Day GDP Course, which provides an extensive introduction to the EU Good Distribution Guidelines.

Some of the Virgin team with staff from dnata – 19th January 2017

We have been thrilled to see the enthusiasm and interest of the Virgin team, which has led to some excellent results in the post-course exam. All passes, with over 80% achieving the highest grade of Distinction, and the rest following closely behind. We hope the entire team is proud of this.

The Virgin Atlantic Cargo Team with Henry Moran and Jamie French – 20th March 2017

Feedback from the course delegates has also been really positive, with every single person agreeing that the course was relevant to their role, and that they learned new skills. This is what ASC are passionate about – helping staff from throughout the entire supply chain understand GDP and how it relates to their individual roles.

The Virgin Atlantic Cargo Team with Amy Shortman – 31st March 2017

We have thoroughly enjoyed working with the Virgin Atlantic Cargo, and look forward to continuing to support this passionate team.

26/04/2017

How silica could change the way we ship vaccines

Earlier this week, Bath University announced the results of research into ensilication, a process which involves encasing a protein in silica, which could have far-reaching effects on the transport of vaccines.

The research, which was carried out by teams at both Bath University and Newcastle University, found that vaccines treated in this way could be heated to 100°C or stored at 22°C for at least six months without loss of function.

Currently, vaccines have to be transported using cool-chain logistics, because a small change in temperature can render them useless. Despite advances in both technology and regulation aimed at making cool chain management more reliable, millions of doses are still lost each year.

The researchers trialled ensilication with three different proteins – one from a tetanus vaccine, horse haemoglobin, and an enzyme from egg white, all with great success. It is hoped that this technology could be expanded to other biopharmaceuticals, such as antibodies, anti-virals, and anti-venom drugs.

Such advances in technology are changing the shape of logistics at an increasing rate, and it fascinating to watch how the numerous challenges faced by the healthcare and life-science logistics industry are gradually being reduced. However it is important to remember that the challenges we face are both numerous and varied – temperature regulation is only one part of the puzzle.

Pharmaceutical cargo is often the target of both thieves and those who deal in counterfeit drugs, and so Supply Chain Security must remain a high priority. For instance, in 2009, a truck carrying vaccines in Wisconsin, US, was reportedly left unattended with the engine running at a delivery point. The truck was stolen and later abandoned, with the cargo seemingly untouched, however the vaccines had to be returned to the manufacturer as a precautionary measure.

Technology cannot prevent user error, and so we must always remain aware of best practice at every stage of the supply chain. However it is exciting to see such promising technological advances being made, and we shall be watching for further news on this research to see how it develops.