Category: Industry News

RX360 partner with ASC Associates to offer audit services to the globally recognised Rx360 audit programme.

 

RX360 partner with ASC Associates to offer audit services to the globally recognised Rx360 audit programme.

Partnership will bring global expertise in Supply Chain Security and Good Distribution Practice to RX360 members.

CAMBRIDGE, UK and PHILADELPHIA, USA, August 3rd, 2020. Rx-360, an international pharmaceutical consortium dedicated to supply chain integrity and patient safety, announces it has signed a partnership with ASC Associates Limited (ASC) a consultancy specialising in Global Supply Chain Security and Compliance. By working in partnership, Rx360 has expanded its programme of audit services available to members. ASC brings extensive knowledge and experience on Global Supply Chain Security and Good Distribution Practice compliance.

Jim Fries, CEO of Rx-360 commented, “Being able to bring choice to our membership when it comes to auditing, is a valuable tool that will continue to drive our goal of reducing industry audit burden. This expansion will also bring added focus to our mission around patient safety”.

Henry Moran, Director of ASC commented, “We are delighted and honoured to be selected as a partner for the Rx360 audit programme. With our extensive audit expertise in Supply Chain Security and Good Distribution Practice, aligned with our knowledge of all supply chain stakeholders and service providers, we look forward to working collaboratively to add value to the RX360 member and to improve global standards”.

 

About RX360

Rx-360 non-profit international consortium addresses pharmaceutical and medical device supply chain security in relation to public health concerns and patient safety. These issues affect billions of individuals around the world on a daily basis. As supply chains become more global, complex and increasingly vulnerable to adulteration and counterfeiting, Rx-360 has increased its focus on strong partnerships between pharmaceutical manufacturers and suppliers to ensure the integrity of supply chains through on-site auditing.

For more information visit RX360

About ASC

ASC Associates are a bespoke consultancy, training and auditing organisation providing services to the Life Science and Pharmaceutical supply chain. In the high-value, pharmaceutical and healthcare worlds – where threats to product safety and security are ever-increasing, we go above and beyond – dedicated to improving all aspects of supply chain logistics.  With a relentless focus on innovation, security, safety, compliance and efficacy, we take extraordinary care with attention to detail. We advise. We assess. We train. We plan. We audit. We scope. We inspect. We implement. In person.

For more information visit ASC or LinkedIn

Nippon Express receives WDA license at LHR

We are delighted that Nippon Express have received their WDA license from the MHRA for Good Distribution Practice of Medicinal Products for Human Use (2013C/ 343/01).  We have been working in partnership with the Nippon Express London team over the last number of years on their GDP project and thanks to the hard work, diligence and professionalism they successfully gained their license in April.

Achieving a WDA license requires extensive auditing and compliance, which is where ASC provided their consultancy, advisory and audit services.

As part of the GDP project we trained over 50 personnel on our bespoke GDP and RP for logistics courses.

ASC were privileged to work with a very strong project team, led by Julian Strutt, Tia Lewis and Damian Tomlinson, and we offer our congratulations to them.

Julian Strutt – General Manager London Regional Branch – Nippon Express

“After shortlisting several companies we chose ASC as a company we felt comfortable working with and by their professionalism and enthusiastic approach.  They set up a thorough training schedule for our Ops Teams which was engaging and interactive, working on case studies and problem solving in small teams. Their help in completing our GDP QMS was invaluable, ASC were always available for advice as and when needed. After a full pre audit walking us through the QMS with us from start to finish we were thoroughly prepared for our MHRA inspection and were awarded with our GDP WDA Licence in April. I have no hesitation in recommending ASC Associates”.

Henry Moran – Director – ASC Associates

“Working with the team at Nippon Express was a real privilege. Their commitment to the project was fantastic, their willingness to learn aligned with their enthusiasm made this project a complete success.  We look forward to continuing to support them with their ongoing training needs. We wish them success on their Life Science service offerings”.

Cold Chain Federation Webinar

DELIVERING EXCELLENCE IN COLD CHAIN COMPLIANCE – WHAT CAN WE LEARN FROM PHARMACEUTICAL LOGISTICS?

ASC Associates had the great opportunity of speaking with Shane Brennan chairman of the Cold Chain Federation on pharmaceutical logistics. The session, a live webinar, focussed on what the food supply chain can learn about compliance and quality from the pharmaceutical industry.  We spoke extensively about Good Distribution Practice and how the principles can be applied in a different market sector.  The webinar is available here

 

Change is afoot.

9 years ago, I set up ASC. It was born out of a love of working within logistics, combined with the flexibility to be able to care for three little humans that my husband and I had brought into the world.

It has been an amazing journey with some great clients. My husband Henry Moran joined my venture in 2015 and we have worked together for the past 4 years. During that time we have developed a company that has supported all the major stakeholders within high-value and pharmaceutical logistics, providing services such as Supply Chain Vulnerability Assessments, GDP Audits/Health Checks and Supply Chain Security Audits. We have also project managed the implementation of a global QMS for a 3PL, developed our own classroom and online training courses such as,  ‘GDP for Logistics‘ and ‘Falsified Medicines & Supply Chain Security’ specifically aimed at the Logistics Industries, and supported airlines and 3PLs in obtaining their WDAs amongst many other projects. We have been fortunate enough to have amazing Associates, such as Tom Cochrane, whose experience and knowledge have strengthened our team, and developed some great partnerships.

This will be my last week with ASC as I have been offered an incredibly exciting opportunity which will be announced publicly very soon. Henry Moran will continue to develop ASC, taking it from strength-to-strength, and will ensure ASC’s clients are well looked after. I know that ASC is in very capable hands.

I would like to take this opportunity to thank all those who have supported me and ASC over the past 8 years. I am staying within this industry, so don’t worry I won’t be going anywhere.

Keep an eye out for my new adventure announcement.

Amy ShortmanASC Amy Shortman CEO

 

PHARMA SECURITY WORLD 2019 ”ANTI-COUNTERFEITING, DRUG SERIALIZATION AND SUPPLY-CHAIN CONFERENCE”

On 19th/ 20th March 2019 in London, UK Corvus Global Events hosted the 2nd Annual Pharma Security World 2019 – Anti-Counterfeiting, Drug Serialization and Supply-Chain Conference, where Pharma industry experts shared various challenges faced, new strategies, case studies and use of innovative ideas and the conference will also offer opportunities to encourage partnerships and collaborations. ASC’s Tom Cochrane shared his 35+ years’ of experience on Supply Chain Security, the important of training those within the supply chain and focused in on the EU’s Falsified Medicine Directive andDrug Supply Chain Security Act (DSCSA)Tom Cochrane ASC Associate

‘The US is driving the path with the approved in 2013. DSCSA guide for end-to-end traceability is extended over a period of 10 years, with expectations sketched throughout the supply chain. The complete supply chain is relied upon to be electronically incorporated and all hubs of traceability to be built up by November 2023. The E.U.’s Falsified Medicines Directive requires drug companies to adopt mass serialization and other anti-counterfeiting measures starting in 2019. Manufacturers who operate in the E.U. will have to add unique identification numbers to the outer packaging of all prescription drugs, and equip containers with tamperproof seals. To guide customers from illicit online drug stores that supply fake medications, the FMD requires approved legitimate Internet drug stores to show a logo distinguishing them as E.U. approved drug retailers.’

The Conference deliberations were on the following themes:

• Understanding and meeting the needs of DSCSA, EU FMD and other global regulations
• Synchrony of the Pharma Industry and professional bodies against counterfeiting
• Tackling pharmaceutical crime – initiatives at multinational, EU and national level
• IP and regulatory enforcement
• Strategies for public awareness and patient protection
• Best practices to protect your brand
• The role of the Internet in aiding the counterfeiters – How to overcome the situation?
• Common Logo initiative in the EU for online pharmacies
• Brand Protection & Securing supply chain integrity
• End to End supply chain visibility
• Developing a sustainable Serialization strategy
• Global enterprise level solutions for anti-counterfeiting
• Integration of track & trace solutions in production and supply chain
• Smart Packaging, Labeling, Artwork, Warehouse & Logistics
• Effective Authentication Technologies
• Best selection of tamper-evident features
• Developing a RMP for your supply chain to protect your Brand, Product and Patient Safety
• Measuring the Effectiveness of a Good Quality System through frequent external and internal audits
• Debating the use and implementation of serialization, barcoding, and RFID
• Serialization Data and Analytics driven approach to increase supply chain agility
• Cloud-based technology complement big data solutions in monitoring and improving supply chain processes
• The need to understand and adopt new technologies like IoT, Analytics, Block chain, Machine Learning and Artificial Intelligence
• Case study: How companies are structuring their counterfeiting efforts and departments?

 

 

IQPC INSIGHTS: SUPPLY CHAIN EFFICIENCY AND NEW TECHNOLOGIES

The future of the pharma logistics sector will be characterised by solutions that are software driven rather than hardware driven. In this article, with insights from Amy Shortman, Founder and CEO of ASC Associates Ltd we will explore how the latest technologies will affect the sector, including:

• How new technologies will bridge communication between all parties and stakeholders in the supply chain

• What real time and predictive software systems mean for temperature excursion management

• How IoT and blockchain will shape a touchless, wireless, and secure logistics operation offering an ‘immutable level of traceability’ for products

Please click here for the full report 

ASC will be presenting this year at TCL 2018, we look forward to seeing you there.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supply Chain Efficiencies & New Technologies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

January28th-31st2019

 

 

 

 

 

 

 

 

 

London,UnitedKingdom

Supply

ChainEfficiency

 

 

And

 

 

 

 

NewTechnologies

 

 

 

 

 

 

 

 

 

 

ExpertinsightfromAmyShortman

FounderandCEOofASCAssociatesLtd

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supply

ChainEfficiency

 

AndNew

Technology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AmyShortmanFounderandCEOofASCAssociatesLtd

RetroactiveLogistics:AThingofthePast…

 

 

 

 

 

 

 

 

 

IoTandblockchainwillenable

 

proactiveshipmentmanagement.Nolongerwillpractitionersberestrictedtopost-shipmentforanalysisandexcursionmanagement,increasingthesector’sabilitytomitigaterisktotheproductandthepatient.

 

 

 

 

 

 

Thefutureofthesectorwillbecharacterisedbysolutionsthataresoftwaredrivenrather

thanhardwaredriven.Thebenefitofthisisthatlogisticsservicesandshipperswillnolongerbetieddowntoasingledevice,orgroupofdevicesthathaverestrictedconnectivity.

 

 

 

 

 

 

Adevice-agnosticsoftwaresystemthat

 

canswitchtothelatesttechnology,whichwillputtheshipperinamuchmoreflexiblepositionintermsoftheirpurchasingability.Itwillalsoensurethatthesectorcanmaintainfluidityand

adapttonewertechnologiesfareasierthanever

 

before.

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pharma4.0,InternetofThings

 

 

 

 

 

 

Formanyyears,thetemperaturecontrolledlogisticssectorsufferedfromtechnologystagnation.Isthisstillthecase?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

“Clientscannowseewheretheirproductisinreal

time.”

Whatdoesinnovationlooklike?

Justonthehorizonisawidearrayofsoftwaresolutionsthatwillmarkashiftfromretrospectiveinterventiontoreal-time

intervention.

 

 

 

 

 

“Thebenefitofthesenewtechnologiesisthatit’sgoingtobereal-timeandpredictive.Whenexcursionsoccur,oraprocessdoesn’toccurasitshould,youhavetheopportunitytofixtheissueinreal-time,asopposedtoretrospectiveanalysis,”saysShortman.

 

 

 

 

 

 

 

“Abigpartofthesenewsolutionsishowthedataspeakstoallinvolvedparties.”Thedatacanbepulledfromdevicesandsenttoindividualsandorganisationswithinthesupplychaintoprevent

incidents.Thiscanbeanythingfromdamagereports,totheft,andtemperatureexcursions.

 

 

 

 

 

“Thesectorisnowatthestagewherewe’rebeginningtomoveawayfromhardwaresolutionsintosoftwaresolutions,”saysShortman.

 

 

 

 

Indeed,thelogisticssectordoesrunarisktopatientsifsoftwareissluggishinadaptingtomeettheindustry’schanges.However,Shortmanhighlightsthatinnovationisaroundthecorner.Therearenowproductscomprisedofindependentsoftwarethatcanconnecttoanydevicetype-andthiskindoftechnologyisavailableacrossthefullrangeoftransportsolutions.

 

 

 

 

Betterstakeholdercollaboration

“Thesectorhascomealongway,”Shortmansays.Whileitstillisn’tperfect,implementinganewtypeofsoftwaretransportationmanagementsystemissignificantlyfasterandmoreefficientthanitwasadecadeago.”Whatisavailableonthemarketnowisalmostlikeplugandplay,withAPIlinkstobringinrelevantdata,thistechnologyishugelybeneficialfromapush-pullpointofview.We’reseeingthatthesesolutionscanbesetupincrediblyquickly,andonceit’supandrunning,it’sallaboutensuringthattheworkflowscorrectly.”

 

 

 

 

Indeed,newtechnologieswillbridgecommunicationbetweenallpartiesandstakeholders.InaTCLscenario,apharmaceuticalcompanycansendatextmessagetoadriver,thedrivercandownloadanapp,andthentakephotographsofthesealofatemperaturereadoutwhilecollectingthe

shipment.Thisinformationcanbeuploadedinrealtimeandcanbesharedwitheveryoneonthesystem,accordingtoShortman.

 

 

 

 

“Ifanairlinewasusingsimilartechnologywecangivethematabletortheycanhaveatabletdevicewheretheycanalsouploadanyrelevantchecklists,againinrealtime,sothatwe’recapturingthataudittrailofwhat’shappening,whenit’shappening,whoit’shappeningby.”

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

January28th-31st2019

 

 

 

 

 

 

 

 

 

London,UnitedKingdom

Supply

ChainEfficiency

 

 

And

 

 

 

 

NewTechnologies

 

 

 

 

 

 

 

 

 

 

ExpertinsightfromAmyShortman

FounderandCEOofASCAssociatesLtd

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supply

ChainEfficiency

 

AndNew

Technology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AmyShortmanFounderandCEOofASCAssociatesLtd

RetroactiveLogistics:AThingofthePast…

 

 

 

 

 

 

 

 

 

IoTandblockchainwillenable

 

proactiveshipmentmanagement.Nolongerwillpractitionersberestrictedtopost-shipmentforanalysisandexcursionmanagement,increasingthesector’sabilitytomitigaterisktotheproductandthepatient.

 

 

 

 

 

 

Thefutureofthesectorwillbecharacterisedbysolutionsthataresoftwaredrivenrather

thanhardwaredriven.Thebenefitofthisisthatlogisticsservicesandshipperswillnolongerbetieddowntoasingledevice,orgroupofdevicesthathaverestrictedconnectivity.

 

 

 

 

 

 

Adevice-agnosticsoftwaresystemthat

 

canswitchtothelatesttechnology,whichwillputtheshipperinamuchmoreflexiblepositionintermsoftheirpurchasingability.Itwillalsoensurethatthesectorcanmaintainfluidityand

adapttonewertechnologiesfareasierthanever

 

before.

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pharma4.0,InternetofThings

 

 

 

 

 

 

Formanyyears,thetemperaturecontrolledlogisticssectorsufferedfromtechnologystagnation.Isthisstillthecase?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

“Clientscannowseewheretheirproductisinreal

time.”

Whatdoesinnovationlooklike?

Justonthehorizonisawidearrayofsoftwaresolutionsthatwillmarkashiftfromretrospectiveinterventiontoreal-time

intervention.

 

 

 

 

 

“Thebenefitofthesenewtechnologiesisthatit’sgoingtobereal-timeandpredictive.Whenexcursionsoccur,oraprocessdoesn’toccurasitshould,youhavetheopportunitytofixtheissueinreal-time,asopposedtoretrospectiveanalysis,”saysShortman.

 

 

 

 

 

 

 

“Abigpartofthesenewsolutionsishowthedataspeakstoallinvolvedparties.”Thedatacanbepulledfromdevicesandsenttoindividualsandorganisationswithinthesupplychaintoprevent

incidents.Thiscanbeanythingfromdamagereports,totheft,andtemperatureexcursions.

 

 

 

 

 

“Thesectorisnowatthestagewherewe’rebeginningtomoveawayfromhardwaresolutionsintosoftwaresolutions,”saysShortman.

 

 

 

 

Indeed,thelogisticssectordoesrunarisktopatientsifsoftwareissluggishinadaptingtomeettheindustry’schanges.However,Shortmanhighlightsthatinnovationisaroundthecorner.Therearenowproductscomprisedofindependentsoftwarethatcanconnecttoanydevicetype-andthiskindoftechnologyisavailableacrossthefullrangeoftransportsolutions.

 

 

 

 

Betterstakeholdercollaboration

“Thesectorhascomealongway,”Shortmansays.Whileitstillisn’tperfect,implementinganewtypeofsoftwaretransportationmanagementsystemissignificantlyfasterandmoreefficientthanitwasadecadeago.”Whatisavailableonthemarketnowisalmostlikeplugandplay,withAPIlinkstobringinrelevantdata,thistechnologyishugelybeneficialfromapush-pullpointofview.We’reseeingthatthesesolutionscanbesetupincrediblyquickly,andonceit’supandrunning,it’sallaboutensuringthattheworkflowscorrectly.”

 

 

 

 

Indeed,newtechnologieswillbridgecommunicationbetweenallpartiesandstakeholders.InaTCLscenario,apharmaceuticalcompanycansendatextmessagetoadriver,thedrivercandownloadanapp,andthentakephotographsofthesealofatemperaturereadoutwhilecollectingthe

shipment.Thisinformationcanbeuploadedinrealtimeandcanbesharedwitheveryoneonthesystem,accordingtoShortman.

 

 

 

 

“Ifanairlinewasusingsimilartechnologywecangivethematabletortheycanhaveatabletdevicewheretheycanalsouploadanyrelevantchecklists,againinrealtime,sothatwe’recapturingthataudittrailofwhat’shappening,whenit’shappening,whoit’shappeningby.”

 

 

 

 

 

 

 

2

WCA & ASC Associates Form Strategic Partnership

12 Oct, 2018

To enhance WCA Pharma’s commitment to GDP compliance

For Immediate Release

BANGKOK, October 12, 2018 – WCA and ASC Associates Ltd are pleased to announce a strategic partnership designed to enhance WCA’s continuing commitment for compliance and logistical innovation in the Pharmaceutical sector. WCA Pharma selected ASC’s bespoke for its 1-day GDP training course for their Pharma GDP Training held at the World Specialty Logistics Fair in Bangkok, Thailand.

ASC’s suite of training includes Good Distribution Practices for Medicinal Products, which has been designed for the logistics industry to enhance compliance within the supply chain. Working in partnership, ASC will offer their expertise in Good Distribution Practices and Supply Chain security to WCA members.

“We have big plans for a close collaboration across several networks, even looking at creating a WCA Academy in the near future,” said Adam Mckenna, General Manager of WCA Pharma. “It’s clear that there is value in what we’re doing. Each time we host a training session, space is filled weeks in advance and our members achieve impressive high scores.”

Amy Shortman, Chief Executive Officer of ASC stated. “We are delighted to have been selected by WCA to offer our services and suite of training to their members. Over the coming months we hope to expand services and training to include courses such as: Anti-bribery and Corruption, Supply Chain Security, Risk Assessments”

WCA is especially grateful to ASC for helping host such a successful session.
“The numbers speak for themselves,” said Mckenna. “With 42 participants and a 100 percent success rate, we’re ensuring that our members are ready and able to handle this business above other forwarders who may not have planned in advance.”

About WCA Pharma:
WCA Pharma is a specialty logistics group under WCA, Ltd and is the world’s leading pharmaceutical logistics network of independent forwarders operating to the highest GDP standards. WCA Pharma members have the experience, know-how and expertise to handle pharmaceutical products, from clinical trials, APIs healthcare (Active Pharmaceutical Ingredients), plasma, to bio pharma, and controlled drugs.

About ASC:
Established in 2011 in the UK, ASC works globally with all key supply chain stakeholders to achieve excellence with a relentless focus on innovation, security, safety, compliance and efficacy.

For further details, please contact:
WCA: www.wcaworld.com / kmode@wcaworld.com
ASC: www.ascassociates.co.uk / info@ascassociates.co.uk

ASC support partners Virgin Atlantic Cargo in successfully obtaining WDA licence from the MHRA

ASC have been working with Virgin Atlantic Cargo for many years on a variety of different projects. The latest of these projects focused on assisting Virgin Atlantic Cargo to gain their WDA license for the London operations, which would enable them to offer their customers a GDP compliant service. Our work with Virgin Atlantic Cargo began in June 2016, and we are pleased to announce that they gained their WDA license in April 2018.

The support of senior management is critical for the successful outcome of any project, but particularly one that involves quality. ASC were privileged to work with a strong project team, led by Virgin’s Darren Sherlock, and we offer our congratulations to them.

“ASC have been instrumental in our growth into the healthcare market, which was recently punctuated with us achieving our WDA certification in the UK. From the initial gap analysis, developing SOPs, and input developing our quality management system, right through to the delivery of training and getting us ready for our final audit; their knowledge and expertise has ensured that we’ve executed each phase of the project successfully. We plan to continue to work with ASC as we further develop, and I’ve every confidence that with their guidance, Virgin Cargo will go from strength to strength in this area.”
Darren Sherlock – Manager, Products and Partnerships | Virgin Atlantic Cargo

THE BEGINNING OF A NEW JOURNEY – VIRGIN ATLANTIC CARGO SET THEIR SIGHTS ON COMPLIANCE

Gaining a WDA license requires extensive auditing and compliance, which is where ASC were able to offer advice and support. The first stage involved 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.

We supported Virgin throughout this process using regular project meetings to ensure momentum was maintained. As part of the project, ASC has trained 80 key personnel 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.

Changing an airline environment into a facility that is operating to the same standards as a Wholesaler of Medicinal Products is a challenge. But Virgin Atlantic Cargo were dedicated to achieving these high standards, enabling them to demonstrate their on-going continuous improvements in quality. By mid-April 2018 the Virgin operation was audited by the MHRA and after a successful audit they received their WDA

WHY CERTIFICATION?

Virgin Atlantic are a global airline who were recently voted the 5th best airline in the world.  Virgin Atlantic Cargo is the subsidiary responsible for the cargo and freight operation of the airline. Founded in 1984, it has been providing award winning services to their customers ever since.

Virgin Atlantic Cargo support the Life Science and pharmaceutical industry by offering a range of solutions for time and temperature sensitive products. Internationally accepted GDP guidelines play a key role in assuring transport and distribution of medicinal products for human use does not adversely impact product quality and integrity. The GDP guidelines focus on well-established pharmaceutical working procedures, and continuously improving distribution and handling expertise.

In the UK the MHRA requires companies hold a wholesale dealer license – or wholesale distribution authorisation (WDA) – when providing short-term storage for refrigerated items. In August 2014, the Medicine and Healthcare Products Regulatory Agency (MHRA) published the document Short- Term Storage of Ambient and Refrigerated Medicinal Product – Requirements for a WDA, which stated the following:

  • Sites holding ambient products in excess of 36 hours must be licensed
  • Sites where refrigerated products are held, even when this is for less than 36 hours, must be licensed (2)

Having these management systems in place gives the customers the confidence that the company have the controls in place to provide continuity, good quality and service.

THE BENEFITS OF A WDA

The WDA is a recognized global quality standard and plays a critical role in assuring transport and distribution of medicinal products for human use does not adversely impact product quality and integrity.

The license provides proof that the Virgin Atlantic operations are “fit for purpose” at their own and at their partners’ facilities.  It also provides evidence that they are operating within a GDP compliant network.

Their customers can be assured that their shipments will be handled in a fully compliant manner.

PLANNING FOR THE FUTURE

The journey has only just begun for Virgin Atlantic Cargo. Regulations are updated, technology advances, and needs evolve, so remaining compliant will require Virgin Atlantic Cargo to remain up-to-date with the latest regulations. ASC will continue to provide advice and support to help Virgin Atlantic Cargo be the best and remain compliant moving forward.

ABOUT ASC AND OUR SERVICES

ASC is distinctive. In the pharmaceutical and healthcare worlds – where external threats to business and intellectual property are ever-increasing, we go above and beyond – dedicated to improving all aspects of supply chain logistics. Established in 2011 we have supported all the major stakeholders within the supply chain on GDP and Supply Chain Security.

With a relentless focus on innovation, security, safety, compliance and efficacy, we take extraordinary care with attention to detail. We advise. We assess. We train. We plan. We audit. We scope. We inspect. We implement. In person.

We’re there at the beginning of your journey, ever-present throughout, and with you at the end. And all along, we’re an experienced and knowledgeable partner, supporting your business to enable you to deliver on your own promises.

If you would like to have a chat about your requirements give us a shout. We’d love to hear from you. 

ASC speaking at 8th Annual Conference Temperature Controlled Logistics in Frankfurt

ASC’s Tom Cochrane to Chair Day 1 and is giving the Keynote speech.

Tom will be sharing his 37 years of experience within the industry by giving the Keynote speech on ‘An Approach to Global Supply Chain Security in Today’s Pharma Industry’.  Tom will cover the following topics:

  • Identifying the risks in the supply chain
  • Designing and implementing a security management system
  • reviewing some examples
  • Sharing best practice

This event will be held at The Steinburger, Frankfurt am Main, Germany on the 17th & 18th May 2018.

Some other topics covered within this conference will be:

  • Explore applications of block chain, temperature monitoring and more. Embrace the globalization of distribution efficiently and safely
  • Building a safe and effective global distribution network
  • Shipping rout verification and cost optimisation
  • Value of smart packaging
  • Digitization of supply chain

We look forward to participating in this event organised by Fleming,  and hearing updates from the industry by an esteemed list of speakers.

 

HDA’s PCSC welcomes Henry Moran as Advisory Board Member

We are delighted to announce that Henry Moran, our COO has been invited to join the prestigious HDA PCSC’s Advisory Board.

The Pharmaceutical Cargo Security Coalition (PCSC) offers supply chain security intelligence; access to contacts from industry, government and vendor trade disciplines; physical and supply chain security assessments; a reference library of supply chain security publications, articles and related documents; as well as opportunities to attend educational events. Primarily (but not exclusively) focused on the pharmaceutical industry, PCSC provides useful insights for anyone interested in supply chain security.

In 2017, PCSC became a service offering of the Healthcare Distribution Alliance (HDA), the national organization representing primary pharmaceutical distributors. HDA members are the vital link between the nation’s pharmaceutical manufacturers and more than 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Learn more about HDA at www.hda.org.