At the beginning of April, the PSCI members got together at AstraZeneca in Södertälje, Sweden for the 2018 Spring Meeting. The agenda included a session on "moving the needle in India", updates from the PSCI committees, and new content from external speakers. We heard from Transparency International on strategies to identify corruption in the pharma & healthcare supply chain, Apotek Hjärtat on driving sustainable customer choices of pharma & healthcare products, and Experian on the EU General Data Protection Regulation and its relevance to PSCI.

We look forward to the Annual General Meeting at Novartis in New Jersey in October.

Dear All,

Today I am proud to share with you PSCI’s Inaugural Annual Report here.

Its publication responds to growth in membership and external interest in our work, and reflects our commitment to operating in a transparent and effective way.

Many of you are passionate about the impact that our industry has on people’s lives and the environments in our supply chains. I share that passion, and wholeheartedly believe in the importance of working collaboratively to improve our effects and better engage with stakeholders. Through our collective influence and expertise, we are better able to drive change and continuous improvement in our supply chains.

Inside the report, you will find highlights and achievements from 2017, a busy and important year for PSCI, and our plans for 2018. We hope you enjoy it, and encourage you to share it amongst your colleagues and wider networks.

Best wishes,

Birgit Skuballa, PSCI Chair, on behalf of the PSCI Board

PSCI is delighted to officially launch the PSCI 2018-2020 Strategy.

A short summary of the new strategy, and the process taken to achieve it, is available to view here.

The strategy is the culmination of 9 months’ work, led by the former Chair, Julie Brautigam, and the wider PSCI Board, and supported by the Secretariat. It was ratified by the members at the Annual General Meeting in October 2017 at Bristol-Myers Squibb near Princeton, New Jersey, USA.

The 2018-2020 Strategy is very much an evolution of the previous strategy, and builds on PSCI’s strong progress in recent years. It retains the emphasis on PSCI audit sharing and supplier capability building. PSCI will continue to promote the PSCI Principles and audit methodologies as the industry standard, while enhancing our Governance with an Advisory Panel, and our Communications through our first Annual Report. We remain open to membership growth.

What’s new? This strategy marks the beginning of a stronger focus on promoting PSCI’s impact and improved communications. We will explore a supplier recognition model, and develop a supplier community to accelerate our impact in the supply chain. We will put a bigger emphasis on partnerships to help us deliver our objectives (and our partners’ objectives) recognising that partners can help us deliver and we can also be a delivery partner for other initiatives.

Thank you to our members for your input to this project - through the 2017 member calls, survey, the workshops at the 2017 Spring Meeting at GSK in London. Thank you also to our stakeholders for participating in the stakeholder consultation interviews and sharing their valuable insights.

We are excited about the future and where this new strategy will take us.
If you are interested in joining the PSCI, please contact info@pscinitiative.org

The Pharmaceutical Supply Chain Initiative (PSCI) held its first training in China for 55 Health & Safety and Environment (HSE) auditors on 21-23 November.

Click here to see the event video.

The three-day training conference in Shanghai brought together senior HSE managers from the world’s largest pharmaceutical companies to share knowledge and provide practical training to third-party audit firms on how to carry out health, safety and environmental (HSE) audits according to the PSCI Principles, which outline the industry expectations on safe and environmentally sound practices in their supply chain.

Dr Birgit Skuballa, PSCI Vice Chair and Head of HSE Management Systems / Audits for Bayer, said “To support our auditing firms we have organized this three-day event with 11 speakers, all highly experienced health and safety professionals from PSCI Member companies. We want to ensure that each individual auditor is capable of carrying out high-quality HSE audits on behalf of the PSCI Members, that means all auditors know how to prepare these audits, professionally conduct them, write understandable and meaningful audit reports and carry-out follow up.”

The training covered topics from industrial hygiene, environmental protection including the prevention from pharmaceuticals entering the environment, to process safety and fire prevention.

Rachel Rae, PSCI Audit Committee Co-Chair and Global HSE Associate at Eli Lilly and Company said that “China is a rapidly growing sourcing country and market for our members, and audit firms struggle to find staff that have the educational background and experience to carry out rigorous audits of our Chinese suppliers. We train audit partners to achieve high safety and environmental standards; it’s a long-term investment in China”.

Speakers at the conference included senior staff from AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Johnson & Johnson and Novartis. The presentations were practical and accessible, and included the use of case studies, group exercises, and question and answer sessions. An exam was held each day to check that the trainees were absorbing the complex material. Feedback from trainees was very positive, and further training is planned.

In 2016-2017, PSCI supported a research study, led by the University of Massachusetts Boston, benchmarking the adoption of Green Chemistry by generic drug companies and active pharmaceutical ingredient (API) manufacturers in the global pharmaceutical supply chain.

The paper summarizing the results has been published by ACS Sustainable Chemistry and Engineering, see here.

At the end of October, the PSCI members got together at Bristol-Myers Squibb near Princeton, New Jersey, for the 2017 Annual General Meeting.

We discussed the new PSCI strategy, which will take effect in 2018, elected two new Board members, shared updates from the PSCI committees, and heard from external speakers including Nordea Asset Management, the AMR Alliance and the Responsible Sourcing Initiative (formerly, EICC).

We look forward to the next member meeting at AstraZeneca in Sweden in April, 2018.

Mark Bannister, Sustainable Procurement Regional Lead at Takeda, represented the PSCI at CPhI Worldwide 2017 in the Pharma insight briefing 'Driving responsible procurement in the pharmaceutical and healthcare sector'.

The event took place in Messe Frankfurt, Germany. To see the highlights, please click here.

A new resource has just been launched exclusively for the PSCI members. This training video is a tool to support members with their navigation on the Audit Sharing Platform.

Follow this link to view the training video.

Please note, to view this training, your login details are required.

If you need support with gaining access to this resource, please contact the Secretariat.

On Wednesday 4th October 2017, the PSCI will run a webinar to:

• launch the new Excel-based supplier self-assessment questionnaire (SAQ) and audit template and
• share information on the supplier self-initiated audit model.

This webinar will be open to members of the PSCI, suppliers and PSCI approved audit companies.

This webinar has now past.

To listen or download the recording which has been split into two parts, click below:

• Part 1: Supplier Self-Initiated Audit Model
• Part 2: Excel Audit Template Launch and Q&A

Please refer to Audit Collaboration section of the website for links to the PSCI Audit Programme tools (including the new Excel templates).

Steven Meszaros, Senior Director of Business Resiliency & Business Development at Pfizer and member of the PSCI Board, presented at the Stockholm International Water Institute (SIWI) World Water Week 2017 in the event, 'Antimicrobial resistance putting sustainable development at risk'.

The theme for the week is "Water and Waste: Reduce and reuse" and runs from 27th August to 1st September.

Steven Meszaros, Senior Director of Business Resiliency & Business Development at Pfizer and member of the PSCI Board, will be presenting at the first United Nations Sustainable Procurement in the Healthcare Sector (SPHS) on Wednesday 23rd August. The webinar will be on Ensuring Fair Play in Global Health Supply Chains.

This webinar has now past.

To listen to the recording, please click here.

In early May, PSCI ran a supplier conference in Hyderabad, India.

It was a remarkable few days, with pre-conference training on the PSCI basics, chemical hazard assessment & runaway reactions, as well as three days of conference featuring over 20 speakers, 6 panellists, and more than 150 attendees representing over 70 suppliers.

Across all 4 days some clear themes emerged: the importance of communication with site employees, proper management systems and record keeping. This accords with the work we do at the PSCI to help suppliers meet the standards we expect, but also to become more the productive, innovative, and resilient to risk; companies that PSCI members want to work with for years to come.

The presentations can be downloaded via the links below:

• Pre-conference session: PSCI Basics
• Pre-conference session: Chemical Hazard Assessment & Runaway Reactions
• Day 1: Process Safety Management
• Day 2: Environmental Performance and Industrial Hygiene
• Day 3: Ethics and Labour

We thank our hosts, Novartis, the organisers, International Safety Systems, and above all, our speakers, without whom we would have no conference. We also thank the attendees for their lively participation and dialogue.

PSCI plans to do more engagement on these and other topics in the future. We look forward to further industry collaboration. Together we can ensure that pharmaceutical production is safe, environmentally responsible, and ethical.

PSCI is delighted to support CHWMEG's seminar on waste issues for European manufacturers on 8th June 2017 in Florence, Italy.

If you are a PSCI member or member supplier interested in attending, contact the Secretariat for more information.

At the beginning of April, the PSCI members got together at GlaxoSmithKline's headquarters in London for the annual Spring meeting. The agenda included a strategy workshop, updates from the PSCI committees, and new content from external speakers. We heard from Mike Barry, Director of Plan A at Marks & Spencer, widely hailed as one of the UK’s sustainability leaders. He inspired the meeting with an engaging talk on 8 emerging trends to watch for the future. Mark Heath, from the Gangmasters and Labour Abuse Authority, spoke about modern slavery in the UK and highlighted how large companies have risk “close to home” in their supply chains; within their sphere of influence.

We look forward to the Annual General Meeting at Bristol-Myers Squibb in New Jersey in October.

The PSCI team has just returned from India where we spent 2 weeks building supplier and auditor capability. We covered a lot and reached dozens of suppliers and contractors.

• 5 sessions at the Green Chemistry Conference in Visakhapatnam with over 179 participants
• 39 CEO or Senior Leaders attended our dinner talk
• 10 company one-to-one sessions
• 47 contract auditors were trained

We were delighted to be joined by Sasja Beslik from Nordea who helped us communicate the importance of addressing sustainability issues to management, engaging them on a financial level that they understand and valued. Most impressive was the strong level of engagement from suppliers and contractors.

Now we are working hard to plan the Supplier Capability Conference that will be held during the week of May 8th in Hyderabad. More details to follow.

Please click here for the auditor training presentation booklet.
Please click here for the photo report from the Green Chemistry Conference and CEO talks.

PSCI is proud to be partnering with LogiPharma, the only global, end-to-end supply chain event for VPs and their teams, taking place from 25 - 27 April, 2017 in Montreux, Switzerland.

Now in its 17th successful year, LogiPharma is the largest global end-to-end supply chain event for pharma supply chain leaders, their teams and service partners.

Download the agenda to find out exactly who is speaking, what the hottest topics are and how LogiPharma can benefit you.

In 2017, PSCI will run an advanced auditor training workshop for HSE auditors from PSCI audit firms and member companies. The goal is to ensure that auditors have the required qualifications and experience to conduct high quality PSCI audits and to ensure that there is enough auditor expertise in key PSCI member sourcing regions. The workshop will be held in Hyderabad, India on 28 Feb – 1 March.

PSCI is delighted to support the GCI Pharmaceutical Roundtable and Green ChemisTree Foundation two-day conference “Green Chemistry & Engineering enabling greater business value for an environmentally responsible Pharma supply chain” on 20-21 February 2017 in Vishakhapatnam, India.

The target audience for this event is R&D and operational staff from API suppliers and PSCI member suppliers are encouraged to attend.

To register online please visit http://bit.ly/2gTJbEN or e‐mail rohit.jain@industrialgreenchem.com

PSCI is delighted to support CHWMEG's training event "Business Sustainability and India Environmental Regulation Updates" in Bengaluru on 24th January 2017.

If you are a PSCI member or member supplier interested in attending, contact the Secretariat for more information.

PSCI is delighted to launch updated versions of the PSCI self-assessment questionnaire (SAQ) and audit templates.

Follow this link to download the full version for core manufacturers
Follow this link to download the abbreviated version for service providers

These versions are in Word, like their predecessors. Long term, PSCI plans to move to Excel templates. The Excel versions have been created and will be launched in 2017 after thorough testing with partner audit firms.

If you have feedback on the new templates, please contact the Secretariat.

The list of PSCI approved audit firms and their contact details can be found here under Who We Work With.

We are delighted to announce that in 2016, Teva, Catalent, DSM-Sinochem, and Sanofi, joined the PSCI, taking our membership count up to 24 pharmaceutical and healthcare companies.

You can see the full list of members on our members page.

In November, Steven Meszaros, Senior Director of Business Resiliency at Pfizer and PSCI Chair, presented to the Global Environmental Management Initiative (GEMI) sharing how PSCI is leading the pharmaceutical industry in the area of supply chain sustainability. We look forward to continued collaboration with GEMI.

On 20th October, Andy Rayment, Risk and Assurance Lead at AstraZeneca and member of the PSCI Board, presented at the Ethical Corporation Sustainable Supply Chain Summit on how PSCI uses it's collective influence to build capacity in the supply chain.

You can watch a video recording here.

In October, the members of the PSCI met at Johnson & Johnson's world headquarters in New Brunswick, New Jersey, USA for the 2016 Annual General Meeting.

On Tuesday 25th October, PSCI will run a third webinar in the series designed to support manufacturing sites on how to manage the release of active pharmaceutical ingredients (API) in wastewater. The webinar is designed for suppliers that handle APIs including API manufacturers, CMOs, CROs, and finished goods suppliers.

We are delighted to be joined by expert speakers: Ed Helmig, Principal Engineer in industrial water and wastewater at AECOM, Dr Rominder Suri, Director of the Temple University W.E.T Centre, Frank Mastrocco, Pfizer’s Director of Environmental Toxicology, and Dan Caldwell, Toxicology Fellow in Environment, Health, Safety & Sustainability at Johnson & Johnson.

Part 1 gave a general introduction to:

• the importance of the topic
• the maturity ladder concept
• how to calculate discharge concentrations

The recording is available here

Part 2 used a case study to show how to put the theory into practice and explained how to make low capital investments to reduce the loss.

The recording is available here

Part 3 will look at more advanced steps to reduce API loss, including reverse osmosis. The presentation is available here

Registration for this event is now closed.

Since the beginning of the year, PSCI has been working with Verisk Maplecroft to take a closer look at modern slavery risk in the pharmaceutical sector.

On Thursday 8th September, this work culminated in a set of informative webinars which:

• gave PSCI members an understanding of the industry's exposure to modern slavery,
• shared detailed analysis of the risk in two key commodities used by the sector, aluminium and sugar, and
• looked at risk mitigation strategies for pharmaceutical companies.

The information will help our members respond to new legislation and take the necessary steps to tackle the issue in their supply chains.

If you missed the webinar, you can download a recording of it here.

On 12th-13th October, PSCI will meet in New Brunswick, New Jersey, for the annual general meeting of the members.

We are delighted to be joined by WWF's David McLaughlin to discuss responsible sourcing of palm oil for the pharmaceutical industry. The talk will cover the environmental and social concerns associated with palm oil, how it and its derivatives are used in the pharma industry, and how the industry might react to help tackle the issues.

From 19-22 September 2016 PSCI ran another very successful (over-subscribed) supplier conference in Shanghai, China, an important supply region for the pharmaceutical sector.

In partnership with DEKRA and the ACS Green Chemistry Institute, the event took a "deeper dive" into responsible business practices. Suppliers were trained on a range of key topics including: chemical hazard assessment, process safety management, green chemistry, industrial hygiene, responsible labour practices, business ethics, and environmental compliance.

The conference is part of our capability building program which aims to build supplier knowledge and expertise so that they can identify and solve social, environmental and ethical issues for themselves.

We look forward to running our next supplier event in India in 2017.

Registration for this event is now closed.

The PSCI gathered in Dusseldorf this month for their biannual meeting which brought together over 40 representatives from PSCI member companies, expert speakers from business, investment, government and consultancy, and companies interested in joining the PSCI.

The event addressed several spotlight issues for the industry. Ole Lund Hansen from the UN Global Compact spoke about the UN Sustainable Development Goals and what they mean for sustainable procurement initiatives. Ignacio Sanchez Diaz from the UN Sustainable Procurement in the Health Sector (SPHS) explained their work to ‘green’ the UN Development Program’s healthcare supply chain, demonstrating overlap between the two organisations and how they can work together. Verisk Maplecroft presented the results of their modern slavery risk analysis for the pharmaceutical sector and insights on compliance with modern slavery legislation. The two days ended with a galvanising talk by Sasja Beslik, Head of Responsible Investment at Nordea Asset Management, on pollution from the pharmaceutical industry in India and how PSCI can help improve the situation.

The meeting also gave the members an opportunity to look inwards at the organisation's governance structures and workstreams. Great progress was documented under all projects – from audit sharing to communications, supplier capability building to governance.

We look forward to the next meeting in October 2016 at Johnson & Johnson.

On Wednesday 15th June, PSCI will run a second webinar in the series designed to support manufacturing sites on how to manage the release of active pharmaceutical ingredients (API) in wastewater. The webinar is designed for suppliers that handle APIs including API manufacturers, CMOs, CROs, and finished goods suppliers.

We are delighted to be joined by expert speakers: Dan Caldwell, Toxicology Fellow in EHS & Sustainability at J&J, Frank Mastrocco, Director of Environmental Toxicology at Pfizer, and Tim Swenson, Environmental Engineer and Associate Director at Pfizer

Part 1 gave a general introduction to:

• the importance of the topic
• the maturity ladder concept
• how to calculate discharge concentrations
• steps sites can take to reduce API process losses

Part 2 will use a case study to show how to put the theory into practice. This worked example will include:

• estimating actual API losses from the manufacturing process (PEC)
• establishing the acceptable discharge concentration (PNEC)
• making low capital investment housekeeping steps to reduce the loss

Part 3, later in the year, will look at more advanced steps to reduce loss, including reverse osmosis.

Registration for this event is now closed

To listen to the recording please download it here
To view the slide deck please download it here
To read the supporting paper, co-authored by our speakers, called A risk based approach to managing APIs in manufacturing effluent please download it here

Happy New Year! We wish you an excellent start to 2016.

To start the year, we want to make sure our members are all properly connected to the PSCI.

1. If you are in any doubt that PSCI emails are getting through to you, please take the following steps:

   • Tell your IT teams to make sure that the PSCI email address – info@pscinitiative.org – is whitelisted by your company firewall.
   • Check your email account spam filters and ensure that emails from this address are not being deleted or ‘sent to junk’.
   • If you need to catch up on emails from the PSCI, please visit the general communication folder on Box.com.

2. Unsure how to use Box? Please let us know by responding to this short survey. If there is demand, we will run a Box demonstration via WebEx later this month.

3. Finally, please follow us on Twitter @PSCInitiative if you have an account, and encourage your corporate Twitter account managers to follow us too.

On Wednesday 27th January, we will run a webinar on managing active pharmaceutical ingredients (APIs) in manufacturing effluent. The webinar is designed for suppliers that handle APIs including API manufacturers, CMOs, CROs, and finished goods suppliers. Whether you are starting a program or advancing an existing one, this step-by-step guidance provided by industry experts will answer questions and set a clear path for action.

We are delighted to have Dan Caldwell, Toxicology Fellow in EHS & Sustainability at J&J and Frank Mastrocco, Director of Environmental Toxicology at Pfizer taking part.

The following topics will be covered:

• Why is managing active pharmaceutical ingredients (API) in manufacturing effluent important?
• What is the industry doing to improve public perceptions?
• Understanding where you stand at the moment through the maturity ladder concept.
• Establishing and calculating API discharge concentration called the Predicted-No-Effect-Concentration (PNEC).
• Simple steps to reducing API process losses to waste water and what to do when the PNEC is exceeded.
• How to advance your program to the next level.

Registration for this event is now closed

To listen to the recording please download it here
To view the slide deck please download it here
To read the supporting paper, co-authored by our speakers, called A risk based approach to managing APIs in manufacturing effluent please download it here

We have recently published our new PSCI Audit Guidance.

This document is for auditors, suppliers, members and other interested stakeholders. It explains the PSCI audit methodology and helps ensure that PSCI audits are carried out in a credible, transparent and consistent way.

What's changed?

Not only is this a more attractive and accessible document; it also properly reflects the PSCI audit process.

• We have changed the focus of the document from the joint audit program, which is ending this year, to the shared audit program, which will continue.
• Consideration has been given to the different types of PSCI audit.
• We have aligned the formatting with the new PSCI branding.
• We have added the pre-audit checklist.

You can download the PSCI Audit Guidance now.

We recently held our 2015 supplier conference – “Business with Balance” – in Mumbai. We were joined by over 200 expert colleagues, representing 70 manufacturing, API and chemicals suppliers.

Participation was excellent and the event saw lively dialogue within the group. The conference addressed labor, ethics, environment, and health and safety topics including industrial hygiene, pharmaceuticals in the environment and waste water management, hazardous waste, and process safety.

The PSCI plans to do more engagement on these and other topics in the future. We look forward to further industry collaboration.

The full presentation pack can be downloaded from the website.

PSCI has been published on the International Trade Centre (ITC) Standards Map which provides comprehensive, verified and transparent information on voluntary sustainability standards. This means that the PSCI standard now has even more visibility and it can be compared with other sustainability standards such as SMETA (SEDEX), EICC, TfS and many more.

The Standards Map is an online platform which enables its users to compare over 180 sustainability standards. It allows users to identify standards or codes of conduct which apply to their own business, review the main features of the selected standards and codes, and assess their business against these standard requirements.

The concept of Human Rights has been around for years, but recent developments have placed explicit requirements on how companies should manage the issue in their supply chains.

The UN Guiding Principles on Business and Human Rights, published in 2011, and led by UN Special Representative John Ruggie, placed obligations on businesses to respect human rights and remedy violations not only in their own operations but within their sphere of influence – including supply chains. Earlier this year, saw the launch of the Framework for reporting against the UN Guiding Principles – effectively defining best practice for reporting on this topic and including supply chain reporting. Several leading companies have either started to use it or committed to do so; Unilever recently published a widely praised human rights report based on this framework.

These voluntary standards are being backed up by the emergence of new legislation: in the US, there is the California Transparency in Supply Chain Act (enacted in 2012), the Business Supply Chain Transparency on Trafficking and Slavery Act of 2014, and the Federal Acquisition Regulation; Ending Trafficking in Persons, 2015, the UK has the UK Companies Act (2006) Regulations 2013 and the UK Modern Slavery Act (2015): Transparency Clause. All these legislative instruments place obligations on companies to tackle human rights within their sphere of influence.

The most recent, the UK Modern Slavery Act, which comes into force in October this year, requires any organization that conducts any part of their business in the UK, and that has annual gross worldwide revenues of £36m or more each year, to publish an annual slavery and human trafficking statement – criteria which include most PSCI members.

We will revisit the topic of human rights and modern slavery at the AGM in October.

In September we will host our 2015 supplier conference in Mumbai, India, which is an important supply region for many of us, and as the industry grows there, so too does the external scrutiny.

The conference is part of our capability building program which aims to build supplier knowledge and expertise so that suppliers can identify and solve social, environmental and ethical issues for themselves.

This year the 3-day conference will focus on Labor, Ethics, Industrial Hygiene, Environmental Protection and Process Safety Management. Joined by several high profile speakers from our PSCI member companies including Vishal Dindorkar from Novartis, Dr. Birgit Skuballa from Bayer Healthcare, Dr. Reinhold Maeck from Boehringer Ingelheim, Bharat Shevkar from Johnson & Johnson, Maharshi Mehta from ISS, Bob Holman from Merck and Jintendra Kumar from Chilworth, we will explore opportunities for improvement for our India based suppliers in each of these topics.

The event will give suppliers:

• An overview of labor and ethics issues in India as well as best practices
• Insights into industrial hygiene and environmental protection challenges in the pharmaceutical / bio-pharmaceutical industry
• The opportunity to review real world Process Safety Management issues using a “Case Study” approach
• A chance to question subject matter experts in each of these fields

More detail can be found in the conference brochure.

If you would like further information please contact the Secretariat.

We are delighted to announce that we have appointed Carnstone Partners LLP as the PSCI secretariat.

Carnstone is an independent management consultancy that specializes in corporate responsibility and sustainability. They have a long track record in running successful collaborative industry projects and they also have considerable experience in working with the pharmaceutical sector on supply chain sustainability issues.

We look forward to continuing the PSCI journey with Carnstone’s support. Please feel free to contact the Secretariat.

We are excited to announce that Takeda Pharmaceuticals have joined the PSCI, taking our membership count up to 18 pharmaceutical and healthcare companies.

“Takeda Pharmaceuticals is pleased to join the Pharmaceutical Supply Chain Initiative. Takeda’s heritage has been built over 230 years by operating with integrity and responsibility and we are excited to extend this practice to our supplier community through the PSCI. Our suppliers are a critical link to ensuring sustainable value for Takeda and most importantly, to our mission of striving towards better health for people worldwide through leading innovation in medicine. Joining the PSCI was a natural next step in our Sustainable Procurement journey, one that seeks to enjoin our suppliers toward a higher standard of sustainability that will create lasting improvements for our world, our society and the patients that we serve.”

Julie Brautigam, Head of Risk and Corporate Social Responsibility.

You can see the full list of members on our members page.