Introduction deck for BSI Group

An introduction deck for EQMS Ingenuity Private Limited

The PSCI presents its report on the use of Horseshoe Crab Blood for Endotoxin Testing in the Pharmaceutical Industry. The report provides insights into the context and complexities behind its use, pathways for better practices in the industry, an insight into the PSCI member companies’ use and next steps both the PSCI and others working in this ecosystem can take going forward.

The PSCI have been engaged on the topic of Horseshoe Crab Blood since 2023. Following the development of its position paper and convening through the working group. The PSCI has been discussing and exploring better pathways for better practices in the pharmaceutical industry and this report encouraging companies to minimize its use and seek alternatives for endotoxin testing in their supply chains.

Pharmaceutical companies use horseshoe crab blood to test medicines and vaccines for safety. The blood is a bright blue colour and has a special quality that makes it incredibly important to human health – it coagulates when exposed to bacterial endotoxins, which can cause sickness or even death in humans.

This project was funded through the projects workstream. Following report publication, the working group aims to publish further capability building resources to support good practices amongst PSCI members. While members are progressing on developing positions on the reduction or elimination of TAL and LAL in their supply chains, only few are be planning for the resilience of its supply.

The PSCI would like to extend a big thank you to Jay Bolden and Shah Shaid, members of the Horseshoe Crab Blood Working Group, the PSCI member companies that responded to the survey and all other contributors for the development of this year’s report.

The SAQ/Audit & Audit Guidance sub-team are pleased to publish the PSCI Pre-Audit Guidance Document Checklist. The checklist has been published as a separate document, previously found in the Audit Guidance as Annex 1.

The audit checklist summarizes important documents which the audit team may want to see in advance for audit preparation or want to review during the onsite audit visit. Depending on the type of supplier or the information provided as per SAQ, the list may be shortened (e.g. for service providers) or extended (e.g. for complex chemical or pharmaceutical manufacturers).

The checklist has been drafted using the current Full SAQ and Audit Report Template, suggesting documents that may be required for each principle (Governance & Management Systems, Ethics, Human Rights, Environment and Health & Safety) and corresponding question.

THE PSCI PRESENTS ITS SECOND PUBLIC AUDIT FINDINGS REPORT, PROVIDING CONTINUED INSIGHTS INTO SUPPLIER RISKS, TRENDS, AND AREAS FOR IMPROVEMENT ACROSS THE PHARMACEUTICAL AND HEALTHCARE SUPPLY CHAIN.

This report shares our analysis of findings from PSCI audits available on our platform. Each year, we review these in line with the PSCI Principles to identify trends, highlight improvements, and share recommendations. Overall, this analysis provides deep insight into supplier practices within the pharmaceutical and healthcare industry and guides us on developing targeted resources and trainings.

The year’s report analyzes 1,776 findings from 180 supplier audits uploaded to the PSCI platform in 2023. These findings are categorized into 308 Management Systems findings, 7 Ethics findings, 169 Human Rights findings, 970 Health & Safety findings, and 322 Environment findings, offering a comprehensive overview of supplier practices and opportunities for improvement. The report includes a summary of findings across key topics, detailed breakdowns with recommended actions for suppliers, and links to relevant

What’s new this year?

• The first-ever analysis by supplier type, providing tailored insights into specific supplier categories.
• A regional analysis focused on major pharmaceutical manufacturing hubs, including China and India.
• A deep-dive analysis of 13 suppliers’ audit data over three years, exploring changes in supplier practices and measuring PSCI’s impact.

The report reinforces the PSCI’s role as a catalyst for continuous improvement, equipping suppliers with tools and guidance to enhance practices and adapt to evolving demands. For more details, access the full report in the resource attached.

You're Invited: PSCI Global Supplier Conference 2025!

Get ready for a highly regarded line-up of expert speakers, insightful discussions, and actionable strategies to drive sustainability in pharmaceutical supply chains.

🔎 Featured Sessions:

• Legislation & Trends – Stay ahead of key legislation on Wastewater, Due Diligence, and Human Rights, and explore current pressures on the pharmaceutical industry related to antimicrobial resistance
• Hands-On Solutions – Explore practical strategies on cybersecurity in process safety, data integration in risk assessments, safety excellence, and more!
• PSCI Showcase – Gain insights into the Pharma LCA and PSCI’s Decarbonization Partnerships

📅 Download the full agenda below. To register, click here.

Don’t miss this opportunity to connect, learn, and contribute to the future of sustainable value chains. Secure your spot today and make every session count!

📩 Spread the Word: Forward this invitation to your colleagues.

If you have any questions, feel free to reach out at info@pscinitiative.org.

See you there!

The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。

Speaker:
Jennifer Jiang | Partner | ERM

演讲嘉宾：
姜煜瑶 | 合伙人 | 伊尔姆

Topic: Scope 3 and Decarbonization
议题：范围三和脱碳

To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮

The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。

Speaker:
Tracy Zhou | External Supply Chain EHS Manager | J&J

演讲嘉宾：
周穗菁 | 外部供应EHS经理 | 强生

Topic: The Management Maturity Model and Audit Findings
议题：PSCI治理与管理体系成熟度模型和审计发现项

To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮

The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。

Speaker:
Lin Wang, Director, BSR China

演讲嘉宾：
王林，中国区总监，商业社会责任

Topic: China labor market practice and impact to business
议题：中国劳动市场的实践以及对商业的影响

To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮

The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。

Speaker:
Jason Jiang| EHS Lead| GSK
Eric Peng| Regional Category Manager| Astra Zeneca

演讲嘉宾：
姜兴| EHS负责人 | 葛兰素史克
彭诗达| 亚太区采购经理 | 阿斯利康

Topic: Human Rights Audits Common Findings & CAPs
议题：劳动者权益审计常见发现项&整改方案| 劳动者权益话题分享

To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮

The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。

Speaker:
Jing DONG | Managing Director | Peterson Solutions China

演讲嘉宾：
董菁 | 总经理 | 上海佩笙检测有限公司

Topic: Social Sustainability in Upstream Supply Chain via Responsible Sourcing Process
议题：通过负责任采购实现上游供应链中的社会可持续发展

To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮

The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。

Speaker:
Gary Lu | APAC SHE & Sustainability Director | AstraZeneca

演讲嘉宾：
卢罡 | 亚太区安全健康环保及可持续发展总监 | 阿斯利康

Topic: China Green Power Project
议题：中国绿电项目

To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮

The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。

Speaker:
Joyce Jiang| Sr Sustainability & Compliance manager, Global Procurement| Roche (Shanghai) Pharmaceuticals Consulting Co.,Ltd.

演讲嘉宾：
蒋南婧 | 全球采购-可持续发展与合规高级经理 | 罗氏（上海）医药咨询有限公司

Topic: Roche’s Journey to Decarbonise its Supply Chain - Challenges & Mitigation
议题：罗氏供应链的减碳之旅-挑战和行动

To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮

The second session of the 2024 PSCI China Supplier Conference took place on September 11, covering Environment, Industrial Hygiene, General Safety, and Process Safety.
2024年中国供应商大会第二天于南京线下举行，覆盖环境、工业卫生、安全总览、过程安全议题。

Speaker:
Don Yu| BD Manager| BSI

演讲嘉宾：
于东 | 商务经理 | 英国标准协会

Topic: BSI Kitemark™ for minimized risk of antimicrobial resistance
议题：BSI与抗生素耐药性认证

To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮

The second session of the 2024 PSCI China Supplier Conference took place on September 11, covering Environment, Industrial Hygiene, General Safety, and Process Safety.
2024年中国供应商大会第二天于南京线下举行，覆盖环境、工业卫生、安全总览、过程安全议题。

Speaker:
Xiaoyuan Zhang| EHS Technical Generalist | Jiuzhou Pharmaceutical Co.LTD

演讲嘉宾：
张孝远| EHS技术总工 | 浙江九洲药业股份有限公司

Topic: Jiuzhou Pharmaceutical Process Safety Management Case Sharing
议题：九洲药业过程安全管理案例分享

To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮

The second session of the 2024 PSCI China Supplier Conference took place on September 11, covering Environment, Industrial Hygiene, General Safety, and Process Safety.
2024年中国供应商大会第二天于南京线下举行，覆盖环境、工业卫生、安全总览、过程安全议题。

Speaker:
William Zhu | Associate Director | WSP

演讲嘉宾：
朱人 | 副技术总监 | 科进

Topic: Statistical Analysis of Industrial Hygiene Monitoring Data
议题：工业卫生数据的统计分析

To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮

The second session of the 2024 PSCI China Supplier Conference took place on September 11, covering Environment, Industrial Hygiene, General Safety, and Process Safety.
2024年中国供应商大会第二天于南京线下举行，覆盖环境、工业卫生、安全总览、过程安全议题。

Speaker:
Roderick Yuan| Technical Director | Shanghai STRM Technology Co., Ltd.

演讲嘉宾：
员文权| 技术总监 | 上海翊员科技有限公司

Topic: Mechanical integrity: Safety critical equipment that are of concern – and how we maintain those
议题：设备完好性-关键安全设施及检查、检测和预防性维护

To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮

The first session of the 2024 PSCI China Supplier Conference took place on September 11, covering Environment, Industrial Hygiene, General Safety, and Process Safety.
2024年中国供应商大会第二天于南京线下举行，覆盖环境、工业卫生、安全总览、过程安全议题。

Speaker:
Carl Deng | Senior Process Safety Consultant | DEKRA Shanghai Office

演讲嘉宾：
邓胤 | 高级过程安全顾问 | DEKRA 德凯达管理咨询（上海）有限公司

Topic: Mechanical Equipment Ignition Risk Assessment (MEIRA)
议题：机械设备点火风险评估（MEIRA)

To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮

During 2024 we will be updating/replacing The Link – the online platform by which we communicate with members and share audits.

We have today launched an open tender exercise to find the best provider. The attached documents have been sent to a small group of selected bidders.

We would welcome the widest possible range of submissions.

Supporting documents:

PSCI Link 2.0 RFP - via the download button below.
Link system map
Link 2.0 user requirements

For ease, please note the following:

Address for correspondence is: LinkRFP@pscinitiative.org
Please confirm your interest to participate by: 10th May 2024
Bid submission deadline: 31st May 2024

Please find the Link 2.0 user requirements.

Please find the system map for the existing link platform

PSCI has conducted a materiality review for the sector every few years (2013, 2017, 2020). We are pleased to publish our latest assessment, this time applying a double materiality framework. The assessment is specifically focused on supply chains for the Pharmaceutical & Healthcare industries, and takes into account member views and a range of outside sources. (For more detail about the double materiality approach, please see here.)

The initial materiality was conducted in Summer 2023 to support development of the new strategy. This has since been updated to take into take into account the final CSRD and to add an additional checking stage to the scoring and issues list.

We encourage members, suppliers and our other stakeholders and invited to read the report and use it as an input to their own planning processes.

For anyone with comments to the report, please contact Rosie.Towe@Carnstone.com.

The PSCI shares its first public Audit Findings Report, providing insight and visibility over key risks, trends, and improvements in the pharmaceutical and healthcare supply chain.

As part of the PSCI's goal to promote consistency, quality, and innovation in all aspects of supplier evaluation and audit, we analyze PSCI audits conducted and uploaded on our shared platform on an annual basis. This report shows what we’ve found by analyzing 3,500 findings from 339 PSCI audits conducted during 2020-2022 and uploaded to the PSCI platform by the end of 2022.

We are specifically interested in understanding how the findings are distributed across the five areas of the PSCI Principles, our blueprint for responsible supply chain management & foundation of our tools. This analysis gives us visibility over how findings are changing over time and our impact on the industry.

This report, the first we have shared publicly, shows the results of a deep dive analysis into each area, focusing on 1,955 findings from 195 PSCI audits uploaded by the end of 2022. These findings reveal key risks, areas for improvement, and opportunities for PSCI members to support their suppliers to improve their practices.

This analysis also provides a high-level understanding of regional differences and levels of maturity, allowing us to provide regionally specific support on hot topics through our capability building work and begin to understand our own impact on the industry.

Speaking of the report's publication, Dorota Wiacek-Trojanowska, Audit Committee member says,

The annual analysis of audit results carried out by the PSCI not only provides information enabling the identification of the most important challenges faced by both PSCI members and suppliers, but also shows new challenges that we must be able to face. The audit results give us the opportunity to collect and analyze information on the biggest challenges in ensuring a sustainable supply chain in the whole pharma sector.

The PSCI has published our 2022 Annual Report, summarizing a year of growing connections and clear movement towards achieving our shared vision of excellence in safety, environmental, and social outcomes across the global pharmaceutical and healthcare supply chain.

Key developments in 2022 include

• Growth to 74 members (an increase of 40% on 2021), with 18 new Associate members
• Developed the PSCI Maturity Models to support structured supplier learning, and in early 2023 launched an app called PSCI Maturity (available in both the Android and iOS stores)
• 32% increase in audits available on the PSCI platform; 801 total & 196 new audits uploaded in 2022
• Over 2,100 supplier attendees at our capability building conferences in India and China
• Became the Official Sustainability Partner of CPHI Worldwide

Vicki Stone-Bjarup, 2022 Chair of the PSCI, says,

Sectors around the world are working to tackle the sustainability challenges of their industry. This report transparently shares the successes that PSCI members have achieved for our sector over the last year, as well as the journey left to take. There is still a long way to go, but we are so proud to be a part of the progress being made in the pharmaceutical industry. Our focus remains to support our members to build responsible supply chains.

Read about these and more in the report below.

Presentation given by Balaji G. at the Musi River Wastewater Workshop 2023.

The first session of the 2022 PSCI China supplier conferences took place virtually on 6 September and covered PiE / AMR and Environment.

Please click “DOWNLOAD” to access to session 1's deck.

The first session includes:

Business continuity plan
Roderick | Technical director | Shanghai STRM Technology Co., Ltd.

PSCI Audit program – practical guidance 
Catherine Zhang | Head of HSE experts APAC | PSCI China sub team lead | Bayer 

Supplier sharing: CAPR formulation & common audit findings 
Ying Lin | EHS & Assistant GM | Zhejiang Raybow Pharmaceutical Co. LTD
Danhua Xu | EHS associate manager | Tianyu Pharmaceutical Co. LTD

The new Data Privacy Law in China
Chris Zhang | Senior partner | Dentons Law Firm

New labor codes 
Minnie Mai | Senior technical manager | TUV

——————————————————————————————————————
业务连续性计划 
员文权 | 技术总监 | 上海翊员科技有限公司

PSCI审计项目分享
张晓花 |亚太区健康安全环境专家组负责人 | PSCI 中国小组负责人 | 拜耳

供应商实践分享: 不同审计体系共性发现项CAPR制定 
林迎 | 总经理助理（分管EHS）| 浙江瑞博制药有限公司
许丹华 | EHS副总经理 | 临海天宇药业有限公司

中国新数据隐私法 
张勇 | 高级合伙人 | 大成律师事务所 

新劳工法规
麦璐 | 高级技术经理 | 德国莱茵

Today the PSCI published its 2021 Annual Report, summarizing a year of exceptional advancement towards achieving our shared vision of excellence in safety, environmental, and social outcomes across the global pharmaceutical and healthcare supply chain.

Key developments in 2021 include:

• Growth in membership, with 53 member companies adopting the PSCI Principles
• Increased audit sharing, with 116 new audits uploaded to our bespoke audit sharing platform
• Finalization of our master supplier learning curriculum, with the launch of our eight maturity models for suppliers to use to advance their practices
• Unprecedented levels of supplier engagement through two large-scale Virtual Supplier Conferences in China and India, reaching 2,000+ attendees
• Promising insights on our impact on the industry, with preliminary analysis on audit data showing that our influence supports positive change on supplier practices

Manjit Singh, 2021 PSCI Chair and Associate Director of Corporate Sustainability at Centrient Pharmaceuticals says,

2021 was a year of spectacular growth for the PSCI in membership and activity. Despite the second year of the Covid-19 pandemic, every aspect of the PSCI's program developed and grew from our shared audits to our supplier capability interactions. I have appreciated the professional and energetic contribution of my fellow PSCI members and watched with great pride the growth of the organization and the impact it has upon our entire industry.

You can read about these advancements and more in the report below.

We welcome comments and encourage you to share this report with your networks using the hashtag #PSCIAnnualReport.

This document addresses the common questions suppliers have around the PSCI audit program. The key points include:

• Who is the PSCI? What is the PSCI Audit program?
• Why should I share a PSCI audit conducted at my site?
• Who can access my audit and is my information secure?
• How do members use the audit reports? Will I be ‘punished’ for a bad audit?
• Can you take me through the PSCI audit steps? How to use the Audit platform?