Content focuses on the role and elements of a quality management system, its impact on the overall risk management approach, and its implementation scientifically and pragmatically. Case studies could demonstrate risk management's purpose, elements, and implementation, a quality management system, and systems validation.
iSpeak Blog
Redefining Quality Through AI Innovation
As industries across the globe navigate increasing complexity, consumer expectations, and regulatory…
iSpeak Blog
Data-Driven Quality: Turning Insights into Action at the 2025 ISPE Pharma 4.0™ Conference
In Pharma 4.0™, quality should no longer be reactive—it’s predictive, connected, and embedded in…
iSpeak Blog
Positioning Commissioning and Qualification (C&Q) as an Integrated Value-Driven Activity in Project Delivery and Beyond
C&Q forms a critical connection between the construction phase and operational readiness of…
iSpeak Blog
Newly published ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing (CM) of Solid Dosage Forms (OSD) Helps Support Broader Adoption of CM
Continuous manufacturing (CM) of oral solid dosage forms has become a well-established approach that…
PE Articles
Industrial ATMP Manufacturing: Digitization’s Role in Aseptic Manufacturing for ATMPs
Over the past decade, Advanced Therapy Medicinal Products (ATMPs) have introduced a significant…
iSpeak Blog
Building the Future: Innovative Facility Design at the 2025 ISPE Pharma 4.0™ Conference
The pharmaceutical industry is under constant pressure to expand capacity, accelerate time-to-market…
iSpeak Blog
Reshaping the Pharma Future: Why the 2025 ISPE Pharma 4.0™ Conference Matters More Than Ever
The pace of innovation—digital joined with operational excellence—in the life sciences industry…
iSpeak Blog
New ISPE Guide: Advanced Therapy Medicinal Products (ATMPs) – Validation Methods and Controls Throughout the Cell and Gene Therapy Lifecycle
Advanced therapy medicinal products (ATMPs) represent a revolutionary frontier in medicine, offering…
iSpeak Blog
Driving Manufacturing Excellence Through Data and Digital Transformation
Engineers know that data is only as valuable as the decisions it drives. The Data-Driven…
iSpeak Blog
Videos: Watch Insights from 2025 ISPE Annual Meeting & Expo Committee Members, Niranjan Kulkarni, PhD, and Robert Perks
The 2025 ISPE Annual Meeting & Expo, ISPE’s largest event of the year, is quickly approaching…
Product
Good Practice Guide: Control Strategy Development for CM of OSD Forms
Published: October 2025 Pages: 72 Table of Contents Special Pricing for Emerging Economies…
iSpeak Blog
Reasons to Attend the 2025 ISPE Annual Meeting & Expo
North Carolina has rapidly emerged as one of the nation’s leading hubs for pharmaceutical…
Guidance Documents
Advanced Manufacturing (1)
Artificial Intelligence (1)
Commissioning & Qualification (5)
- Good Practice Guide: Heating, Ventilation & Air Conditioning 2nd Edition
- Good Practice Guide: Decommissioning Pharma Equipment & Facilities
- Good Practice Guide: Controlled Temperature Chambers 2nd Edition
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
Compounding (1)
Data Integrity (16)
- Good Practice Guide: Digital Validation
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- GAMP Good Practice Guide: Manufacturing Execution Systems
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity by Design
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Drug Shortages (1)
Facilities of the Future (1)
GAMP® (15)
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- GAMP Good Practice Guide: Manufacturing Execution Systems
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity by Design
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Good Manufacturing Practice (8)
- QMS SOP Template: Product Recall Management
- QMS SOP Template: Product Quality Complaints
- QMS SOP Template: Out-of-Specification
- QMS SOP Template: Investigations
- QMS SOP Template: Environmental Monitoring Excursions
- QMS SOP Template: Deviation Management
- QMS SOP Template: CAPA Management
- Guide: 503B Compounding
Knowledge Management (6)
- GAMP RDI Good Practice Guide: Data Integrity by Design
- APQ Guide: Cultural Excellence
- APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
- APQ Guide: Change Management (CM) System
- APQ Guide: Management Responsibilities & Review (MRR)
- APQ Guide: Corrective Action & Preventive Action (CAPA) System
Lifecycle Management (3)
Manufacturing Operations (11)
- Good Practice Guide: Control Strategy Development for CM of OSD Forms
- Guide: Sustainability
- QMS SOP Template: Product Recall Management
- QMS SOP Template: Product Quality Complaints
- QMS SOP Template: Out-of-Specification
- QMS SOP Template: Investigations
- QMS SOP Template: Environmental Monitoring Excursions
- QMS SOP Template: Deviation Management
- QMS SOP Template: CAPA Management
- Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
- GAMP Good Practice Guide: Manufacturing Execution Systems
Microbiological & Viral Contamination Control (3)
Oral Solid Dosage (1)
Process Analytical Technology (6)
- Good Practice Guide: Control Strategy Development for CM of OSD Forms
- Good Practice Guide: Validation 4.0
- PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles
- PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example
- APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
- PQLI Guide: Part 4 - Process Performance & Product Quality Monitoring System
Project Management (1)
Quality Assurance (9)
- Good Practice Guide: Digital Validation
- Guide: 503B Compounding
- Good Practice Guide: Process Validation
- APQ Guide: Cultural Excellence
- APQ Guide: Change Management (CM) System
- APQ Guide: Management Responsibilities & Review (MRR)
- APQ Guide: Corrective Action & Preventive Action (CAPA) System
- PQLI Guide: Part 3 - Change Management System
- The Cultural Excellence Report - Six Key Dimensions
Quality Control (1)
Quality by Design (6)
- ISPE Guide: ATMPs – Validation Methods & Controls
- Good Practice Guide: Validation 4.0
- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
- PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles
- PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
Regulatory (4)
- Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
- Good Practice Guide: Heating, Ventilation & Air Conditioning 2nd Edition
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
Sustainability (1)
Sustainable Facilities, HVAC, & Controlled Environments (2)
Validation (15)
- ISPE Guide: ATMPs – Validation Methods & Controls
- Good Practice Guide: Validation 4.0
- Good Practice Guide: Digital Validation
- Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- Good Practice Guide: Process Validation
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Community Discussions
Community Discussions
Nov 07, 2025
Critical Utilities
Quality Assurance
Nov 07, 2025
Nov 06, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Nov 04, 2025
Nov 03, 2025
GAMP®
Oct 31, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Oct 30, 2025
Pharmaceutical Engineering Magazine Articles
Industrial ATMP Manufacturing: Digitization’s Role in Aseptic Manufacturing for ATMPs
Over the past decade, Advanced Therapy Medicinal Products (ATMPs) have introduced a significant…
Volunteer Profile: Nina S. Cauchon, PhD, Product Quality Lifecycle Implementation (PQLI)® Committee Co-Chair
Nina S. Cauchon is Director Regulatory Affairs (RA) Chemistry, Manufacturing, and Controls (CMC) at…
Volunteer Profile: Celeste Frankenfeld Lamm, PhD, Product Quality Lifecycle Implementation (PQLI)® Committee Co-Chair
Celeste Frankenfeld Lamm encourages young professionals to identify and pursue the aspects of their…
ISPE Assists Health Canada with ICH Q13 Guidance Training
ISPE successfully assisted Health Canada with International Council for Harmonisation (ICH) Q13…
Expand Your Knowledge and Network at ISPE Annual Meeting & Expo
As professionals in pharmaceutical engineering, we are challenged to develop medications and…
Ensuring Drug Product Safety Compliance Strategies Under USP 665 and 1665
The United States Pharmacopeia (USP) Packaging and Distribution Expert Committee approved chapters…
Balances and Scales Metrology and Fitness for Intended Use
Defining requirements for calibration and routine testing of weighing equipment in the laboratory…
Barriers to Innovation in Pharmaceutical Manufacturing Insights From Five Case Studies
In April 2023, ISPE launched a survey to understand the sources of barriers to technological…
Readiness for Implementation of ICH Q2(R2) and Q14 Industry Survey Results
The International Council for Harmonisation (ICH) Q2(R2) and Q14 guidelines, finalized in late 2023…
Streamlining Post-Approval Changes Industry Insights on ICH Q14
Simplified approaches that enable changes to analytical procedures over their lifecycle are needed…
Validation 4.0 for the Pharmaceutical Industry
The pharmaceutical industry is under increasing pressure to develop new therapies at a faster pace…
Message from the Chair: Exploring Regulatory Trends and Quality Initiatives with ISPE
ISPE is proud to celebrate its 45th anniversary of working with regulators and professionals from…
ISPE in the News
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Fill in the blank: "If the use of leisure time is confined to _____ for a few extra hours every day, we will deteriorate as a people." -- Eleanor Roosevelt, 1958
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ISPE Academy: GAMP® Essentials Certificate
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ISPE Regulatory Initiative: Drug Shortages
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How To Ease AI Anxiety
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Ecolab Introduces New Cleanroom Sporicide
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Sandoz Buys Evotec's Toulouse, France, Site
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Gene Therapies May Spur The Body To Make GLP-1
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White Papers
January / February 2025
GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical…
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
January / February 2024
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
Videos
iSpeak Blog Posts
Pharmaceutical Job Board
Pharmaceutical Job Board
Professional Development Training
Hands-On Aseptic Processing & Annex 1
This course will focus on aseptic processing and quality management regarding pharmaceutical technology. The training course will provide ample time in clean rooms for various practical exercises, allowing participants to engage in hands-on operations. These sessions will occur in the clean rooms of the EASE platform.
Quality Events
High-level overview of quality event management principles and practices. This course offers a high-level summary of quality event topics as an addition to the Quality Events SOP Guidance Documents package. Instead of detailing how to carry out each task, it highlights why these elements are vital for a complete quality system. The course covers the core principles of root cause analysis, CAPA implementation, and effective recall and complaint handling, ensuring learners grasp their importance for regulatory compliance and operational excellence. By the end, participants will understand…
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…
ICH Q9(R1): Guidelines on Pharmaceutical Risk Management
Delivery Mode: Webinar An introduction to the ICH Q9(R1): Guidelines on Pharmaceutical Risk Management. This lesson covers the fundamentals for assessing and mitigating risks during drug product lifecycles and incorporates the latest requirements from ICH Q9(R1), which was updated in 2023, and supports and sets the foundation for a safety and quality-centric approach. By integrating with other ICH standards, it sets the foundation for a safety and quality-centric approach. CEUs are provided once you achieve an 80% passing grade and complete the evaluation. The course is self-paced. On average…
ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
Delivery Mode: Webinar This course covers testing and quality control requirements in marketing authorization/new drug applications, emphasizing ICH guidelines. It focuses on ICH Q6A, detailing test procedures and acceptance criteria for new drug substances/products to ensure global consistency and safety. The course also integrates later guidelines (ICH Q8, Q9, Q10, Q11), introducing science and risk-based approaches. Participants will learn to navigate global marketing authorization/new drug applications, contributing to high-quality pharmaceutical product development. CEUs are provided once…
GxPs for Leadership
This comprehensive course will equip you with the knowledge and skills to ensure GxP compliance and inspection readiness in the pharmaceutical industry. You will thoroughly understand regulatory requirements and learn about management's role in maintaining safety and quality. The course covers essential topics such as regulatory expectations, responsibilities in compliance, and consequences of non-compliance.
GMP Refresher
Code of Federal Regulations (CFR) states that "Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them." This course will provide an overview of History, Regulations, Quality Systems, and development, with a focus on distinguishing between QA and QC in GMP. It can serve as a GMP refresher for both individuals and companies and ensures that current key trends are covered. CEUs are provided once you achieve an 80% passing grade…