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
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…
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…
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
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…
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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Oct 31, 2024
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Oct 23, 2024
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iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
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…
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…
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…
Videos
Professional Development Training
ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
+GMP Fundamentals for the Pharmaceutical Industry
+GMP Auditing for Quality Assurance Training Course
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White Papers
March / April 2025
A Skill Management Framework for a Pharma 4.0™ Workforce Feature: Pharma 4.0™ is driving fundamental…
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…
