Our resource library is made available freely to all in order to advance responsible supply chain practices. Here you will find information and guidance on responsible supply chain issues and the way that the PSCI works. If you have any suggestions for improvements or additions to our resources please contact us.
The second session of the 2022 PSCI India supplier conferences took place in-person on the 22nd of September and covered Audit, Environment, Scope 3, PiE/AMR
The full slide deck is available for download below.
Engaging Suppliers to Reduce Scope 3 Emissions Towards Net Zero Robert Williams, Director of Procurement Sustainability, Astra Zeneca
Ban on Identified Single Use Plastic – The Whats, Whys and Hows Ashish Jain, Founder-Director, Indian Pollution Control Association (IPCA)
Climate change – Risks to Organizations Shivananda Shetty, Partner & Head, ESG and Climate Change, KPMG
Supplier Water Quality & Pharmaceuticals in Environment Balaji Gurumurthy, Environmental Compliance Lead, Novartis
Reducing AMR Risk Through Effective Control of Antibiotic Manufacturing Emissions Dharmesh Kharwar, Director, NGB Laboratories
PSCI Musi River Project Manjit Singh, Associate Director of Corporate Sustainability, Centrient Pharmaceuticals Senthil Kumar, Supplier Operations, Pfizer
Case studies – Implementation of Good Practice in Management of API Containing Waste Streams Ashok Kumar Podisetty, Head of EHS, Neuland Laboratories Limited
Developing PiE/AMR Capabilities in India Aditya Shirodkar, Global Senior EHS Specialist, Abbott
Mitigate pharmaceuticals in production wastewater : PIE theoretical evaluation, testing and treatment technologies Dr. Reinhold Maeck，Head of Corp EHS Regulatory Intelligence, BI Corporate EHS&S Li Liu , EHS Manger, BI China EHS&S
生产废水中的药物移除 : 环境中的药物理论评估与检测 Dr. Reinhold Maeck，公司EHS法规智能主管，勃林格殷格翰
刘立，EHS经理，勃林格殷格翰
The following document provides guidance on potential techniques, methodologies, and available data sources for the calculation of dilution factors. The correct approach to follow is dependent on specific aspects of the risk assessment to be conducted. The PSCI does not advocate a single correct approach or data source, but aims to provide information to help risk assessors design assessments suitable for their requirements.
The contents of this document has been kindly shared by the IAI PiE Task Force.
The following document provides guidance on potential techniques, methodologies, and available data sources for sampling and analysis of pharmaceutical industry wastewater. The correct approach to follow is dependent on specific aspects of the risk assessment to be conducted. The PSCI does not advocate a single correct approach or data source, but aims to provide information to help risk assessors design assessments suitable for their requirements.
The contents of this document has been kindly shared by the IAI PiE Task Force.
More great publicity for the PSCI with thanks to Dan Caldwell (Johnson & Johnson) and Steve Brooks (AMR Alliance) who recently recorded this CPhI podcast on pharmaceuticals in the environment (PiE) and anti-microbial resistance (AMR) and what the industry is doing to help address the challenge.
The PSCI has published a PEC:PNEC calculator tool for manufacturers to use to calculate how to meet safe levels of discharge for active pharmaceutical ingredients (APIs) from their sites.
At the PSCI, we’re committed to doing everything in our power to limit that the spread and growth of two emerging threats – Pharmaceuticals in the Environment (PiE) and Anti-microbial Resistance (AMR). That’s why for World Health Day, we’re excited today to launch our new Position Statement, which provides a clear explanation of the critical role we play in helping our supplier partners improve their manufacturing practices. The statement has been written to highlight the relevance of the PiE issue along the supply chain, to articulate the PSCI's position on this high profile topic, and to help answer stakeholder inquiries. It includes an overview of all PSCI resources on PiE and AMR-related issues.
The second session of the 2020 PSCI China supplier conferences took place virtually on 24 September and covered Environment, Pharmaceuticals in the Environment/AMR.
The full recording of the session is available here (code:PSCI). Slides are available for download below.
Recordings and slides of individual presentations are also available as individual resources - please click on the relevant links below:
The webinar explored best practice wastewater treatment methods for managing the release of APIs into the environment from pharmaceutical manufacturing sites. It was delivered by renowned experts and featured case studies on novel treatment technologies.
We were delighted to be joined by the following speakers:
Jeffrey Brenchley from Merck (MSD) (Senior Specialist, Global Safety & Environment), speaking about vacuum evaporation
Birgit Mertens from Johnson & Johnson (Senior Principal Environment Worldwide EHS&S), speaking about ozone as pretreatment
Jonathan Rhone from Axine Water Technologies Inc. (President and CEO), speaking about electrochemical oxidation
Participants are invited to share feedback about this webinar here.
The recording is available here. (Please refresh the page if you cannot play the video.)
The slides used during the webinar are available to download below.
Please also note that registration for the second session of our supplier conferences is open until 17 September. Topics covered will include climate change (GHG) & sustainable packaging ; sampling and analysing APIs in wastewater with case studies ; a case study on Controlling API Releases; environmental hazards of drugs and case analysis ; and mass balance calculations. To register, please click here for the China session and here for the India session.
Finally, we want your views! We're encouraging all suppliers to take this short survey to help the PSCI understand the impact it has on suppliers.
On behalf of the Board and Communications Committee and with thanks to the Pharmaceuticals in the Environment (PiE)/ Anti-Microbial Resistance (AMR) sub-team for their expert input, we are sharing the recently adopted PSCI Position Statement on PiE & AMR. It has been written to highlight the relevance of the PiE issue along the supply chain, to articulate PSCI's position on this high profile topic, and to help answer stakeholder inquiries. It includes an overview of all PSCI resources on PiE and AMR-related issues.
In this webinar we will be looking at the impact of pharmaceutical manufacturing on antimicrobial resistance, as well as demonstrating PSCI's PEC:PNEC calculator tool.
Our speakers will be covering the issues associated with antimicrobial drugs in wastewater, targets for environmental risk assessment of antimicrobial drugs, and how to assess the risk of antimicrobial drugs in wastewater.
We are delighted to be joined by the following speakers:
Daniel Caldwell, Global Director, Environmental and Occupational Toxicology at Johnson & Johnson;
In this webinar we will be looking at the impact of pharmaceutical manufacturing on antimicrobial resistance, as well as demonstrating PSCI's PEC:PNEC calculator tool.
Our speakers will be covering the issues associated with antimicrobial drugs in wastewater, targets for environmental risk assessment of antimicrobial drugs, and how to assess the risk of antimicrobial drugs in wastewater.
We are delighted to be joined by the following speakers:
Daniel Caldwell, Global Director, Environmental and Occupational Toxicology at Johnson & Johnson;
This version has been updated. Please refer to the newer version.
This Excel spreadsheet tool provides instructions and guidance on how to assist pharmaceutical manufacturers in calculating how to meet predicted no effect concentration values (PNECs) for active pharmaceutical ingredients (APIs) discharged in wastewater from manufacturing operations.
This is the slide deck from the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 4) which took place on 10th July 2018.
The webinar gave a brief refresher on Pharmaceuticals in the Environment (PiE), Anti-Microbial Resistance (AMR) and Predicted No-Effect Concentration (PNEC) first principles, and introduced a PSCI resource page where PNECs can be found. It also included step-by-step guidance on how to locate PNECs and use them.
This is recording of the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 4) which took place on 10th July 2018.
The webinar gave a brief refresher on Pharmaceuticals in the Environment (PiE), Anti-Microbial Resistance (AMR) and Predicted No-Effect Concentration (PNEC) first principles, and introduced a PSCI resource page where PNECs can be found. It also included step-by-step guidance on how to locate PNECs and use them.
The following are useful resources for obtaining PNEC values.
AMR Industry Alliance Antibiotic Discharge Targets - List of Predicted No-Effect Concentrations (PNECs).
The PNEC table contains two values, PNEC‐Environment (PNEC‐ENV) values based on eco-toxicology and PNEC‐Minimum Inhibitory Concentration (PNEC‐MIC) values intended to be protective of resistance promotion.
The AMR Industry Alliance recommendation is that companies target the lower of these two values (when available) for assessing manufacturing site discharges under a risk‐based framework.
This is the slide deck for the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 3) which took place on 25th October 2016. The webinar looked at advanced technologies to reduce API loss with guest speakers from the Temple University WET Centre and AECOM.
This is recording of the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 2) which took place on 15th June 2016. The webinar provided step-by-step guidance on this ‘spotlight’ issue for our industry and covered the following topics:
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 of APIs
This is the slide deck for the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 2) which took place on 15th June 2016. The webinar provided step-by-step guidance on this ‘spotlight’ issue for our industry and covered the following topics:
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 of APIs
This is the slide deck for the PSCI sponsored webinar on how to manage APIs in manufacturing effluent which took place on 27th January 2016. The webinar provided step-by-step guidance on this ‘spotlight’ issue for our industry and covered the following topics:
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.
This is a recording of the PSCI sponsored webinar on how to manage APIs in manufacturing effluent which took place on 27th January 2016. The webinar provided step-by-step guidance on this ‘spotlight’ issue for our industry and covered the following topics:
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.
Abstract: This Caldwell et al. study describes guidance intended to assist pharmaceutical manufacturers in assessing, mitigating, and managing the potential environmental impacts of active pharmaceutical ingredients (APIs) in wastewater from manufacturing operations, including those from external suppliers.
