Content highlights regulations and guidance issued by international regulatory bodies and coalitions. Case studies could demonstrate the application of regulations and industry-generated guidance for global harmonization of compliance and product registration. Topics could include regulations, standards, practices, and guidance related to drugs, the environment, health, and safety.
Initiatives
Current Topics
Guidance Documents
Active Pharmaceutical Ingredients (2)
Advanced Manufacturing (1)
Advanced Therapy Medicinal Products (1)
Biotechnology (3)
Critical Utilities (5)
Drug Shortages (2)
Good Manufacturing Practice (1)
Investigational Products (3)
Knowledge Management (2)
Lifecycle Management (2)
Manufacturing Operations (3)
Microbiological & Viral Contamination Control (6)
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Good Practice Guide: Membrane-Based WFI Systems
- D/A/CH Affiliate: WFI Handbook (English Translation)
- Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
- Japan Affiliate: Pest Control Manual (English Translation)
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Quality Assurance (2)
Quality Control (1)
Regulatory (5)
Sterile Products (1)
Supply Chain Management (2)
Community Discussions
Community Discussions
Nov 25, 2024
Biotechnology
Nov 25, 2024
Data Integrity
Nov 25, 2024
GAMP®
Nov 25, 2024
Data Integrity
Nov 21, 2024
Regulatory
Regulatory
Nov 18, 2024
Regulatory
Regulatory
Nov 17, 2024
Sustainable Facilities, HVAC, & Controlled Environments
Manufacturing Operations
Pharmaceutical Engineering Magazine Articles
Evolving China’s Regulatory System in Alignment with ICH
With the Chinese government initiating drug regulatory reform in 2015 and China joining the…
New EU AI Regulation and GAMP® 5
This article describes how ISPE GAMP ® 5: A Risk-Based Approach to Compliant GxP Computerized…
Risk Management for Avoidance of Drug Shortages
Shortages of essential medicines around the world have been an ongoing concern for patients…
Enabling Global Pharma Innovation: Delivering for Patients
ISPE has launched an important new initiative, “Enabling Global Pharma Innovation: Delivering for…
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…
ICH Q13 and What Is Next for Continuous Manufacturing
The creation of a new ICH guidance document, Q13, International Council for Harmonisation of…
Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing
Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This…
A New Regulatory Approach to Drive Sustainable Medicines
To enable changes across the pharmaceutical industry, sustainability should be included alongside…
ISPE Briefs: New Guide Helps Maintain and Establish PPPQMS
ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Process Performance and Product Quality…
2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More
The 2022 ISPE Aseptic Conference Regulatory Panel session on 15 March was as always one of the…
Regulatory Landscape for Raw Materials: CMC Considerations
A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients…
Streamlining Postapproval Submissions Using ICH Q12 & SCDM
Postapproval change management of pharmaceuticals is an essential part of life-cycle management but…
Webinars
ISPE in the News
Latest
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I never thought I was ever going to be a travel writer. I was just having a wonderful time traveling on the slimmest of funds.
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Mentor ISPE 2025
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A Message from the 2025 ISPE Aseptic Conference Chair
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Pii Invests $3.6M in Advanced Tech for Prefilled Syringes
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Sartorius Opens Bioprocess Innovation Hub in Mass.
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Fujifilm Diosynth Expands Calif. Cell Therapy Plant
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Netherlands Grants GMP Certification to Ardena Nanomedicine Plant
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BioPharmaSpec Expands with 3 European Facilities
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Execution Inconsistencies Hamper Validation Efficiency
- Potential US FDA Policy Shifts on the Horizon
White Papers
September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of…
March / April 2024
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…
September / October 2023
Regulatory Trends & Quality Initiatives - Shortages of essential medicines around the world have…
January / February 2022
Emerging Leaders has grown from an initiative for interactions among early-career professionals and…
Videos
iSpeak Blog Posts
Featured Conferences
Pharmaceutical Job Board
Professional Development Training
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…
CAPA / RCA / Investigations Training Course
Coming Soon 2024 - CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management Maturity.
Pre-Approval Inspection Readiness Training Course
This new training course on the elements necessary to ensure readiness for pre-approval inspections provides strategy and tactics towards preparation than can be customized to individual organization requirements.
Implementation of ICH Q12 Guideline
Delivery Mode: Webinar ISPE Team Assists Training Health Canada with Implementation of ICH Q12 Guideline, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Regulatory Background International Council for Harmonisation’s (ICH) guideline entitled, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” (ICH Q12) provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Implementation of ICH’s…
Biopharmaceuticals: CMC Aspects
This instructor led course is an advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development. The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization. An emphasis will be placed on using Quality by Design principles to develop, manufacture and guide the product lifecycle. Lastly, we will examine biosimilars and regulatory factors that affect product development and the product lifecycle and drug costs.