Sustainability is the implementation of systems and processes to assess and control the risks of environmental impacts and health and safety hazards when producing Pharmaceutical products.
PE Articles
ISPE Announces Sustainability Community of Practice
Governments around the world have made international commitments to reduce their environmental…
PE Articles
Net-Zero Manufacturing Facilities: Obstacles and Benefits
The decision to pursue net-zero facility design in manufacturing is complicated. There are…
PE Articles
Volunteer Profile: Sustainability Community of Practice Chair - Ester Lovsin Barle, DVM, MSC, PHD, MSCTOX
Ester Lovsin Barle’s journey from veterinary lecturer in Slovenia to the Global Head of Product…
PE Articles
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
PE Articles
Setting Net-Zero Targets: Tangible Benefits of Sustainability
Many organizations are on the right path to sustainability, but more can still be done— especially…
PE Articles
Decarbonizing Pharmaceutical Manufacturing Facilities
Reducing the pharmaceutical industry’s carbon footprint has become a management responsibility. This…
PE Articles
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
PE Articles
Emerging Leaders Editorial: Sustainability and Opportunities for Emerging Leaders
The pharmaceutical, biotechnology, and medical device industries continue to grow as patients…
Video
Mechanical Recycling of Post-Use Bioprocessing Plastic Containers
Mechanical Recycling of Post-Use Bioprocessing Plastic Containers Complimentary Learning Level…
Video
FOYA Category Social Impact: Chugai Pharma Manufacturing Co, Ltd
UK4 is a biological drug substance manufacturing facility that was designed and built under a “Three…
iSpeak Blog
Supply Chain Resiliency and Sustainability: Transforming Pharma at the 2024 ISPE Annual Meeting
The pharmaceutical industry stands at the cusp of a transformative era, where the integration of…
PE Articles
Room Differential Pressures in Facility Design: Fundamentals
The expectations for room differential pressures to maintain air quality in pharmaceutical facility…
Guidance Documents
Commissioning & Qualification (2)
Containment (2)
Microbiological & Viral Contamination Control (3)
Supply Chain Management (1)
Sustainable Facilities, HVAC, & Controlled Environments (6)
- Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
- Good Practice Guide: Cold Chain Management
- Good Practice Guide: Containment for Potent Compounds
- Good Practice Guide: Controlled Temperature Chambers 2nd Edition
- Good Practice Guide: HVAC & Process Equipment Air Filters
Community Discussions
Community Discussions
Mar 14, 2025
Data Integrity
Mar 14, 2025
Advanced Manufacturing
Critical Utilities
Feb 16, 2025
Workforce of the Future
Feb 15, 2025
Manufacturing Operations
Feb 13, 2025
Manufacturing Operations
Oral Solid Dosage
Feb 10, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Pharmaceutical Engineering Magazine Articles
ISPE Announces Sustainability Community of Practice
Governments around the world have made international commitments to reduce their environmental…
Net-Zero Manufacturing Facilities: Obstacles and Benefits
The decision to pursue net-zero facility design in manufacturing is complicated. There are…
Volunteer Profile: Sustainability Community of Practice Chair - Ester Lovsin Barle, DVM, MSC, PHD, MSCTOX
Ester Lovsin Barle’s journey from veterinary lecturer in Slovenia to the Global Head of Product…
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
Setting Net-Zero Targets: Tangible Benefits of Sustainability
Many organizations are on the right path to sustainability, but more can still be done— especially…
Decarbonizing Pharmaceutical Manufacturing Facilities
Reducing the pharmaceutical industry’s carbon footprint has become a management responsibility. This…
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
Emerging Leaders Editorial: Sustainability and Opportunities for Emerging Leaders
The pharmaceutical, biotechnology, and medical device industries continue to grow as patients…
Room Differential Pressures in Facility Design: Fundamentals
The expectations for room differential pressures to maintain air quality in pharmaceutical facility…
Automation Supports ESG Goals for Pharma Facility Conversion
Implementing advanced automation technologies is a strategic move that can amplify the positive…
Environmental Sustainability in Biopharmaceutical Facility Design
Many emerging tools and technologies support the environmental sustainability of the pharmaceutical…
Case Study: Meeting Manufacturing Needs with a Net Zero Energy Facility
The expected FDA approval for a Treprostinil dry powder inhaler revealed a need for the manufacturer…
Professional Development Training
Good Engineering Practice (GEP) Training Course
This course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. GEP provides a foundation required across the pharmaceutical industry that other areas, such as GxP build upon. This course, based on ISPE Good Practice Guide: Good Engineering Practice (Second Edition) also defines and clarifies GEP as an enabling process for Quality Risk Management…
ICH Q7: API Guidelines
The ICH Q7 guideline ensures consistent quality and safety in the production of Active Pharmaceutical Ingredients (APIs) by defining globally recognized Good Manufacturing Practices (GMP) for all stages of API manufacturing.
ICH Q8: QbD in Manufacturing
The ICH Q8 guideline ensures a systematic approach to pharmaceutical development by defining globally recognized Quality by Design (QbD) principles to enhance product quality throughout all stages of development.
ICH Q10: Pharmaceutical Quality System (PQS)
The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies…
A GAMP® Guide to Computerized Systems Compliance
Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP ® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. Course Modules…
White Papers
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
March / April 2023
As the pharmaceutical industry faces ever-changing global challenges and market forces, it must…
