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
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…
Video
The Use of Engineering Change Management (ECM)
Complimentary Learning Level: Basic Session Length: 1 hour Asset Life Cycle Management evolves in…
PE Articles
Industry Perspectives on Practical Application of Platform Analytical Procedures
Pharmaceutical and biotechnology companies employ platform analytical procedures in the development…
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…
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
iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
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…
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. 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 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…
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
