Quality Control (QC) is a detailed system of inspection and control covering the production, evaluation, and distribution of pharma drugs a manufacturer produces.
PE Articles
AI Compliance in Life Sciences: 5 Key Requirements
By focusing on the five key areas we’ve identified below you have confidence in the AI you are…
iSpeak Blog
Driving Better Outcomes for Quality Control Labs
Quality control (QC) manufacturing labs are ripe for transformation. Historically relying on legacy…
PE Articles
Visual Inspection Is Key to Ensuring Patient Safety in US Pharmaceutical Compounded Products
Visual inspection is nothing new to professionals who make, prescribe, prepare, and/or administer…
PE Articles
Reimagining Informed Consent: AI Avatars in the Era of Complex Clinical Trials
Informed consent aims to provide clinical trial participants with transparent education about the…
Video
Quality Risk Management Commissioning & Qualification: Key Deliverables & Lessons Learned Webinar
Quality Risk Management Commissioning & Qualification: Key Deliverables & Lessons Learned Webinar…
iSpeak Blog
Driving Excellence in Pharma: Explore the Manufacturing, Quality Control, and Operational Excellence Track at the 2025 ISPE Annual Meeting & Expo
Pharmaceutical manufacturers are always under pressure to move faster, stay compliant, and deliver…
Video
Improved Data Integrity via Digitization of Environmental Monitoring
Improved Data Integrity via Digitization of Environmental Monitoring Complimentary Learning Level…
Video
Quality Culture Matters: Key to Unlocking the Digital Validation Power
Quality Culture Matters: Key to Unlocking the Digital Validation Power Extended Learning Learning…
Video
Blue Sky Lab Automation for the QC Industry
Blue Sky Lab Automation for the QC Industry Complimentary Learning Level: Advanced Session Length: 1…
PE Articles
3R Initiative Within Roche’s Global QC Network
This article describes the numerous activities in the commercial quality control (QC) network that…
iSpeak Blog
ISPE Releases Updated ISPE GAMP® Good Practice Guide on Validation and Compliance of Computerized Good Clinical Practice (GCP) Systems and Data
The use of digital information in clinical trials has evolved and expanded rapidly in recent years…
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Guidance Documents
Critical Utilities (1)
Microbiological & Viral Contamination Control (2)
Community Discussions
Community Discussions
Nov 07, 2025
Critical Utilities
Quality Assurance
Nov 06, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Oct 31, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Oct 20, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Oct 20, 2025
Quality Control
Oct 18, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Oct 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Webinars
iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
Visual Inspection Is Key to Ensuring Patient Safety in US Pharmaceutical Compounded Products
Visual inspection is nothing new to professionals who make, prescribe, prepare, and/or administer…
Reimagining Informed Consent: AI Avatars in the Era of Complex Clinical Trials
Informed consent aims to provide clinical trial participants with transparent education about the…
3R Initiative Within Roche’s Global QC Network
This article describes the numerous activities in the commercial quality control (QC) network that…
Industry Perspectives on Practical Application of Platform Analytical Procedures
Pharmaceutical and biotechnology companies employ platform analytical procedures in the development…
Quality Risk Management for Biopharmaceuticals
In the dynamic and highly regulated world of biopharmaceutical manufacturing, maintaining and…
Continuous Buffer Management System: Large-Scale Buffer Preparation
Although traditional tank farm systems have long been the cornerstone of buffer preparation, they…
ISPE Briefs: Introducing New ISPE Baseline® Guides
The newly released third edition of the ISPE Baseline® Guide: Volume 6 – Biopharmaceutical…
Benefits and Challenges of Process Capability Metrics
Process capability is a fundamental concept for manufacturers. Pharmaceutical, biopharmaceutical…
Cleanroom Recovery Study: Using Computational Fluid Dynamics Methodology
Computational fluid dynamics (CFD) can reduce or eliminate the uncertainty associated with a…
Rapid Filter or Resin Change Strategies for Biomanufacturing
Pandemic-related supply chain shortages have placed constraints on the supply of essential filters…
Master Soil Selection for Cleaning Validation of Parts Washers
One of the goals of the cleaning validation design phase is to define critical process parameters…
GMP Implementation of Online Water Bioburden Analyzers
Online water bioburden analyzers (OWBAs) are analytical instruments providing real-time or near real…
Videos
Professional Development Training
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…
GMP Fundamentals for the Pharmaceutical Industry
This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process.
GMP Auditing for Quality Assurance Training Course
This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities.
White Papers
November / December 2025
In This Issue: We dive into sustainable practices in the pharma industry and effective ways to…
September / October 2025
As regulatory trends and quality initiatives continue to evolve in the pharmaceutical industry, this…
July / August 2025
The AI Paradox Cover: The increasing digitalization of the pharmaceutical and medical device…
