PE Magazine | November / December 2024
Decarbonizing Pharmaceutical Manufacturing Facilities

Reducing the pharmaceutical industry’s carbon footprint has become a management responsibility. This article introduces some of the key points, actual methods, and practical examples of our implementation to reduce carbon emissions from pharmaceutical manufacturing facilities in Southeast Asia.

Read More
PE Magazine | November / December 2024
Net-Zero Manufacturing Facilities: Obstacles and Benefits

The decision to pursue net-zero facility design in manufacturing is complicated. There are significant challenges related to initial project costs, physical space constraints, and project site considerations—but also substantive benefits from operational savings, environmental impact, building brand trust, and working toward a more sustainable future.

Read More
iSpeak Blog | 2 December 2024
Bridging Innovation and Compliance: Navigating Annex 1 Implementation with Global Experts

The pharmaceutical manufacturing landscape is becoming increasingly complex, especially with new regulations and technological advancements. 

Read More
2024 ISPE Annual Meeting & Expo View Recap Guidance Documents 75+ documents available Membersip Join 22,000+ members

ISPE Highlights

Honoring Innovation and Leadership: ISPE’s Pharma 4.0™ Baseline Guide Authoring Team Wins the 2024 ISPE International Honor Award for Committee of the Year
Biochemist-examining-vaccine-evolution-using-high-tech-researching-diagnosis
Emer Cooke, European Medicines Agency (EMA) Executive Director and chair of the International Coalition of Medicines Regulation Authorities (ICMRA)
Digital Innovation Conference Debut from ISPE Australasia
WIP Panel Roma 2024
Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition
Eli Lilly Kinsale Limited
factory-worker-white-gown-rubber-gloves-holding-plastic-bottle
Gear Up 6.0: Classroom to Career – student chapter career development program of the ISPE Philippines Affiliate, 13 July 2024 
Bridging Innovation and Compliance: Navigating Annex 1 Implementation with Global Experts
Validation of an Automated Parts Washer
Pharma 4.0™: Case Studies and Lessons Learned

Pharmaceutical Engineering Magazine

View All

Guidance Documents

Good Practice Guides
Guide Cover
Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition
Good Practice Guides
Guide Cover
Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
Good Practice Guides
Guide Cover
Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
Good Practice Guides
Guide Cover
Good Practice Guide: Unique ID of Glass Primary Containers
Guides
Guide Cover
Guide: 503A Compounding
Guides
Guide Cover
Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt
Guides
Guide Cover
Guide: ATMPs - Allogeneic Cell Therapy
Baseline Guides
Guide Cover
Baseline Guide Vol 8: Pharma 4.0 1st Edition
Baseline Guides
Guide Cover
Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
Good Practice Guides
Guide Cover
Good Practice Guide: Process Gases 2nd Edition
Guides
Guide Cover
Guide: 503B Compounding
Good Practice Guides
Guide Cover
Good Practice Guide: Containment for Potent Compounds
View All

Regulatory Initiatives

Quality Culture
QC Regulatory
Product Quality Lifecycle Implementation (PQLI) ®
Lifcyc Mgmt Regulatory
Advancing Pharmaceutical Quality™
QA Regulatory
View All

Highlights From ISPE Knowledge Network

Explore webinars, training PE articles, and more relevant to your job function.
 
Facilities & Equipment
  1. Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition
  2. 2024 FOYA Banquet Recap: Celebrating Excellence and Tips for Submitting to the 2025 Facility of the Year Awards
  3. Process Considerations When Designing mAbs Production Facilities
  4. Global Adoption Status and Implementation of ICH Guidelines Q12, Q2(R2), and Q14
View Related Content
Information Systems
  1. Global Adoption Status and Implementation of ICH Guidelines Q12, Q2(R2), and Q14
  2. FDA CDER Associate Director Speaks About Regulatory Reliance and Agility
  3. A Message from the 2025 ISPE Aseptic Conference Chair
  4. Unlock the Future of Pharmaceutical Manufacturing: Learn from Industry Leaders at the 2024 ISPE Pharma 4.0™ and Annex 1 Conference
View Related Content
Management
  1. Global Adoption Status and Implementation of ICH Guidelines Q12, Q2(R2), and Q14
  2. FDA CDER Associate Director Speaks About Regulatory Reliance and Agility
  3. A Message from the 2025 ISPE Aseptic Conference Chair
  4. Overcoming Fear of the Engineer-Procure-Construct (EPC) Model to Recognize Project Execution Benefits
View Related Content
Product Development
  1. Advancing Precision Medicine with ADCs and Radiopharmaceuticals
  2. Process Considerations When Designing mAbs Production Facilities
  3. Global Adoption Status and Implementation of ICH Guidelines Q12, Q2(R2), and Q14
  4. FDA CDER Associate Director Speaks About Regulatory Reliance and Agility
View Related Content
Quality
  1. Global Adoption Status and Implementation of ICH Guidelines Q12, Q2(R2), and Q14
  2. FDA CDER Associate Director Speaks About Regulatory Reliance and Agility
  3. A Message from the 2025 ISPE Aseptic Conference Chair
  4. Post Approval Changes and ICH Q12
View Related Content
Regulatory
  1. EMA Executive Director Discusses the Future of Innovation and Regulation
  2. Global Adoption Status and Implementation of ICH Guidelines Q12, Q2(R2), and Q14
  3. FDA CDER Associate Director Speaks About Regulatory Reliance and Agility
  4. A Message from the 2025 ISPE Aseptic Conference Chair
View Related Content
Supply Chain
  1. Global Adoption Status and Implementation of ICH Guidelines Q12, Q2(R2), and Q14
  2. FDA CDER Associate Director Speaks About Regulatory Reliance and Agility
  3. A Message from the 2025 ISPE Aseptic Conference Chair
  4. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
View Related Content

Conferences

2025 ISPE Facilities of the Future Conference

-
San Francisco, CA US

2025 ISPE Aseptic Conference

-
ARLINGTON, VA US

2025 ISPE Europe Annual Conference

-
London, GB

2025 ISPE Biotechnology Conference

-
Boston, MA US

2025 ISPE Pharma 4.0™ Conference

-
Barcelona, Spain ES
View All

Webinars

Upcoming
On-Demand
 
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies Extended…
Quality Culture Matters: Key to Unlocking the Digital Validation Power
Quality Culture Matters: Key to Unlocking the Digital Validation Power Extended Learning Learning…
Purified Water Microbial Testing: False OOS Due to TNTC vs Filtration Volume
Purified Water Microbial Testing: False OOS Due to TNTC vs Filtration Volume Complimentary Learning…
Improved Data Integrity via Digitization of Environmental Monitoring
Improved Data Integrity via Digitization of Environmental Monitoring Complimentary Learning Level…
Holistic Pharma 4.0 Digital Maturity Assessment
Complimentary Learning Level: Basic Time: 1000 - 1100 EST Session Length: 1 hour The pharmaceutical…
View All
Blue Sky Lab Automation for the QC Industry
Blue Sky Lab Automation for the QC Industry Complimentary Learning Level: Advanced Session Length: 1…
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes Extended Learning Learning…
Complimentary Member Orientation and Benefits Webinar
Complimentary Member Orientation and Benefits Webinar Complimentary Learning Level: Basic Session…
Medical Device Sterilization with FDA
Medical Device Sterilization with FDA Complimentary Learning Level: Intermediate/Advanced Session…
Mentor ISPE Virtual Open House, Power and Led By Women in Pharma
Mentor ISPE Virtual Open House, Power and Led By Women in Pharma ® Session Length: 1 hour We are…
AI/ML in Regulated Life Sciences (GxP) Sectors - Project/Operation Phase: Computerized System Integration and Acceptance
AI/ML in Regulated Life Sciences (GxP) Sectors - Project/Operation Phase: Computerized System…
ISPE FOYA Submission Best Practices
ISPE FOYA Submission Best Practices Complimentary Learning Level: Basic Session Length: 1 hour Join…
Unique Glass Primary Containers Identification in Pharmaceutical Fill & Finish Operations
Unique Glass Primary Containers Identification in Pharmaceutical Fill & Finish Operations…
Bridging the Gap: Leveraging Capital Project Data to Enhance the Pharma Manufacturing Operations Lifecycle
Bridging the Gap: Leveraging Capital Project Data to Enhance the Pharma Manufacturing Operations…
ALCOA++: Leveling Up Data Integrity
ALCOA++: Leveling Up Data Integrity Complimentary Session Length: 1 hour ALCOA has been the hallmark…
Women in GAMP®
Women in GAMP ® Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour Join us for…
The Use of Engineering Change Management (ECM)
Complimentary Learning Level: Basic Session Length: 1 hour Asset Life Cycle Management evolves in…
View All

Training Courses

Upcoming
On-Demand
 
View All
View All
Access Your Member Benefits
Collaborate on a global scale, drive innovation, lead conversations, and more. Become a member of ISPE.
Arrow 42 YEARS of serving pharma professionals Arrow 20,000+ MEMBERS in over 120 countries Arrow 40 AFFILIATES AND CHAPTERS worldwide Arrow 70+ GUIDANCE DOCUMENTS written by ISPE Members Arrow 6+ INTERNATIONAL CONFERENCES per year Arrow A ROBUST LIBRARY of learning resources Arrow 24-HOUR ACCESS to ISPE Members worldwide
Learn More Join Now

Increased Access to Good Practice Guides

With an ISPE membership, you’ll gain access to 24+ Good Practice Guides.

Good Practice Guide
Guide Cover
C&Q of Pharma Water & Steam Systems 2nd Edition
Good Practice Guide
Guide Cover
Assessing Particulate Containment 2nd Edition
Good Practice Guide
Guide Cover
Asset Management
Good Practice Guide
Guide Cover
Booklet Labels
Good Practice Guide
Guide Cover
Clinical Supply Systems
Good Practice Guide
Guide Cover
Cold Chain Management
Good Practice Guide
Guide Cover
Comparator Management
Good Practice Guide
Guide Cover
Decommissioning Pharma Equipment & Facilities
Good Practice Guide
Guide Cover
Development of Investigational Therapeutic Biological Products
Good Practice Guide
Guide Cover
Harmonizing the Definition and Use of NIMPs
Good Practice Guide
Guide Cover
Heating, Ventilation, & Air Conditioning (HVAC)
Good Practice Guide
Guide Cover
HVAC & Process Equipment Air Filters
Good Practice Guide
Guide Cover
Interactive Response Technology
Good Practice Guide
Guide Cover
Management of Engineering Standards
Good Practice Guide
Guide Cover
Operations Management
Good Practice Guide
Guide Cover
Ozone Sanitization of Pharma Water Systems
Good Practice Guide
Guide Cover
Packaging, Labeling, & Warehousing Facilities
Good Practice Guide
Guide Cover
Process Validation
Good Practice Guide
Guide Cover
Process Gases
Good Practice Guide
Guide Cover
Project Management for the Pharmaceutical Industry
Good Practice Guide
Guide Cover
Quality Lab Facilities
Good Practice Guide
Guide Cover
Sampling Pharma Water, Steam, & Process Gases
Good Practice Guide
Guide Cover
Single-Use Technology
Good Practice Guide
Guide Cover
Technology Transfer

Get Involved

Enhance your ISPE Membership through involvement at the local and international level. Through knowledge sharing, networking, and engaging thought leadership, you can contribute to shaping the future of the pharmaceutical industry.
Join Your Local Affiliate or Chapter Arrow Join a Community of Practice Arrow Become a Thought Leader Arrow

ISPE Membership

ISPE is the most dynamic community in the industry, with a global network of 20,000+ professionals spanning the complete pharmaceutical lifecycle. With resources available for all stages of your career, an ISPE Membership is a career game changer.
Join or Renew Today Arrow Member Benefits Arrow Learn About Membership Arrow

Community Discussions

Dec 10, 2024
Data Integrity
Dec 10, 2024
Biotechnology
Containment
Dec 04, 2024
GAMP®
Dec 04, 2024
Good Manufacturing Practice
Dec 04, 2024
GAMP®
Lifecycle Management

Videos

Recommended
Latest
 
2024 ISPE Year in Review
Shape the Future of Pharma - Join ISPE Today!
2024 ISPE FOYA Category Winner for Innovation: Eli Lilly Kinsale Limited
View All
Attend the 2024 ISPE Biotechnology Conference
2024 ISPE International Women's Day
2024 ISPE Aseptic Conference - Why Attend
View All

Latest Issue

November / December 2024

November / December 2024

Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical industry, focusing on using single-use technologies (SUT...
View This Issue

Corporate Partners

View Corporate Partners