PE Magazine | September / October 2024
FDA’s 2011 Process Validation Guidance: 10 Years On

In 2011, the US Food and Drug Administration (FDA) introduced the revised “Guidance for Industry: Process Validation: General Principles and Practices.” The document incorporated principles from existing ICH guidance in place since 2005 (ICH Q8 and Q9) and 2008 (ICH Q10).

Read More
iSpeak Blog | 30 October 2024
Mentor ISPE 2025—Key Dates and Application Details

The 2025 Mentor ISPE program promises to be a transformative year filled with growth, collaboration, and valuable learning opportunities for both mentors and mentees.

Read More
iSpeak Blog | 23 October 2024
Pharma 4.0™ and Annex 1 Implementation: A New Era for Aseptic Manufacturing

The pharmaceutical industry is in the middle of a transformative shift, driven by the dual forces of Pharma 4.0™ and the updated Annex 1 guidelines. These changes are introducing innovations that not only enhance the quality and safety of sterile manufacturing but also leverage new technologies to optimize efficiency and compliance.

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

ISPE Highlights

ISPE International Board of Directors at FOYA-banquet-2024
Mentor ISPE
Antonio Moreira, PhD
Quality-Management-System
Source: SKAN AG
Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition

Pharmaceutical Engineering Magazine

View All

Guidance Documents

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
APQ
Guide Cover
APQ Guide: Cultural Excellence
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: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
  2. 2024 ISPE FOYA Category Winner for Innovation: Eli Lilly Kinsale Limited
  3. 2024 ISPE FOYA Category Winner for Operations – Facility Fit: Takeda
  4. 2024 ISPE FOYA Category Winner – Honorable Mention: United Therapeutics Corporation
View Related Content
Information Systems
  1. A GAMP® Guide to Computerized Systems Compliance
  2. Pharma 4.0™ and Annex 1 Implementation: A New Era for Aseptic Manufacturing
  3. ISPE Releases Updated ISPE GAMP® Good Practice Guide on Validation and Compliance of Computerized Good Clinical Practice (GCP) Systems and Data
  4. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
View Related Content
Management
  1. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  2. Unlock the Future of Pharma: Don’t Miss This Year's Premier Pharma Industry Conference
  3. Explore AI Solutions and Pursue Digital Transformation-Related Technology Advancements in the Pharmaceutical Industry: Join the 2024 ISPE Annual Meeting & Expo
  4. Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo
View Related Content
Product Development
  1. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  2. Unlock the Future of Pharma: Don’t Miss This Year's Premier Pharma Industry Conference
  3. Explore AI Solutions and Pursue Digital Transformation-Related Technology Advancements in the Pharmaceutical Industry: Join the 2024 ISPE Annual Meeting & Expo
  4. Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo
View Related Content
Quality
  1. A GAMP® Guide to Computerized Systems Compliance
  2. Pharma 4.0™ and Annex 1 Implementation: A New Era for Aseptic Manufacturing
  3. Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
  4. ISPE Releases Updated ISPE GAMP® Good Practice Guide on Validation and Compliance of Computerized Good Clinical Practice (GCP) Systems and Data
View Related Content
Regulatory
  1. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  2. Unlock the Future of Pharma: Don’t Miss This Year's Premier Pharma Industry Conference
  3. Explore AI Solutions and Pursue Digital Transformation-Related Technology Advancements in the Pharmaceutical Industry: Join the 2024 ISPE Annual Meeting & Expo
  4. A Holistic Mindset is Key to Supply Resiliency
View Related Content
Supply Chain
  1. Explore the Possibilities of Pharmaceutical Advancement with Digital Tools, Including AI/ML at the 2024 ISPE Annual Meeting & Expo
  2. Unlock the Future of Pharma: Don’t Miss This Year's Premier Pharma Industry Conference
  3. Explore AI Solutions and Pursue Digital Transformation-Related Technology Advancements in the Pharmaceutical Industry: Join the 2024 ISPE Annual Meeting & Expo
  4. Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo
View Related Content

Conferences

2024 ISPE Pharma 4.0™ and Annex 1 Conference

-
Rome, Italy IT

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
View All

Webinars

Upcoming
On-Demand
 
Complimentary Member Orientation and Benefits Webinar
Complimentary Member Orientation and Benefits Webinar Complimentary Learning Level: Basic Time: 1600…
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes Extended Learning Learning…
Blue Sky Lab Automation for the QC Industry
Blue Sky Lab Automation for the QC Industry Complimentary Learning Level: Advanced Time: 1000 - 1100…
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…
View All
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…
Mechanical Recycling of Post-Use Bioprocessing Plastic Containers
Mechanical Recycling of Post-Use Bioprocessing Plastic Containers Complimentary Learning Level…
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
Complimentary Member Orientation and Benefits Webinar
Complimentary Member Orientation and Benefits Webinar Complimentary Learning Level: Basic Session…
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning…
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

Nov 04, 2024
Information Systems
Management
Pharma 4.0™
Project Management
Nov 04, 2024
Regulatory
Supply Chain
Active Pharmaceutical Ingredients
Good Manufacturing Practice
Nov 03, 2024
Women in Pharma®
Nov 02, 2024
GAMP®
Lifecycle Management
Oct 31, 2024
Regulatory
Quality
Good Manufacturing Practice
Sustainable Facilities, HVAC, & Controlled Environments

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

September / October 2024

September / October 2024

PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry...
View This Issue

Corporate Partners

View Corporate Partners