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
Continuous Buffer Management System: Large-Scale Buffer Preparation
Content originally published in Pharmaceutical Engineering® May/June 2024, Volume 44, Number 3…
PE Articles
Quality Risk Management for Biopharmaceuticals
In the dynamic and highly regulated world of biopharmaceutical manufacturing, maintaining and…
PE Articles
Continuous Buffer Management System: Large-Scale Buffer Preparation
Although traditional tank farm systems have long been the cornerstone of buffer preparation, they…
iSpeak Blog
Quality Management Maturity: The Strategic Vision for Biopharmaceutical Excellence
To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for…
PE Articles
ISPE Briefs: Introducing New ISPE Baseline® Guides
The newly released third edition of the ISPE Baseline® Guide: Volume 6 – Biopharmaceutical…
PE Articles
Benefits and Challenges of Process Capability Metrics
Process capability is a fundamental concept for manufacturers. Pharmaceutical, biopharmaceutical…
Product
Good Practice Guide: Quality Lab Facilities
ISPE has produced the industry’s first Guidance Document to establish a baseline for the design of…
iSpeak Blog
Insider’s Guide to Manufacturing, QC, and Operational Excellence
The 2023 ISPE Annual Meeting & Expo features Manufacturing, Quality Control, and Operational…
iSpeak Blog
ISPE QC/Analytical Community of Practice Established
Quality Control (QC) is a vital part of CMC (chemistry, manufacturing, and controls), which ensures…
PE Articles
Cleanroom Recovery Study: Using Computational Fluid Dynamics Methodology
Computational fluid dynamics (CFD) can reduce or eliminate the uncertainty associated with a…
PE Articles
Rapid Filter or Resin Change Strategies for Biomanufacturing
Pandemic-related supply chain shortages have placed constraints on the supply of essential filters…
Video
GAMP® 5 Guide, 2nd Edition: Why It's Needed
Maintaining the principles and framework of the first edition published in 2008, the much…
Guidance Documents
Critical Utilities (1)
Microbiological & Viral Contamination Control (2)
Community Discussions
Community Discussions
Nov 04, 2024
Regulatory
Supply Chain
Active Pharmaceutical Ingredients
Good Manufacturing Practice
Oct 31, 2024
Regulatory
Quality
Good Manufacturing Practice
Sustainable Facilities, HVAC, & Controlled Environments
Oct 23, 2024
Quality
Active Pharmaceutical Ingredients
Good Manufacturing Practice
Aug 20, 2024
Critical Utilities
Quality Control
Jun 13, 2024
Information Systems
Regulatory
Advanced Manufacturing
Active Pharmaceutical Ingredients
Webinars
iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
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…
Quality Risk Management to Address Product Impurities
Recently, recalls of angiotensin receptor antagonists, particularly valsartan, and warning alerts…
Technology Trends: The Transition to Digitalization
In the pharmaceutical industry, digitalization involves developing and implementing digital…
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. Buy Now Return to…
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
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
March / April 2024
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…
