Oral Solid Dosage (OSD) is the inspection and evaluation of the manufacturing and control processes used to manufacture solid oral dosage form pharmaceutical products.
iSpeak Blog
Should Your Company Switch to Continuous Manufacturing?
As the benefits of continuous manufacturing became more apparent in the pharmaceutical industry…
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Regulatory Aspects of Global Acceptance of Continuous Manufacturing
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Material Properties Databases to Advance Pharmaceutical Processing
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Video
ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition)
Dave DiProspero, Co-Team Leader of the ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition)…
Basic page
2017 Category Winner for Facility of the Future and Overall Winner
Eli Lilly and Company Location: Indianapolis, Indiana, USA and Carolina, Puerto Rico Project…
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Driving Operational Excellence: Lean Six Sigma Integration in Complex CMO Operations
Driving Operational Excellence: Lean Six Sigma Integration in Complex CMO Operations Complimentary…
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Process Validation Lifecycle for Packaging Oral Solid Dosage Forms
The ISPE Discussion Paper “Overview of Packaging Validation for Drug Products” explores the…
Product
Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition
The ISPE Baseline Guide: OSD Forms is intended to offer a tool for consistent framework for…
Product
Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
This Guide reviews the unit operations typically employed in continuous manufacturing and aims to…
PE Articles
ISPE Briefs: A Comprehensive Reference for Continuous Manufacturing of OSD
The pharmaceutical industry began applying the principles of continuous processing to the…
PE Articles
Artificial Intelligence Used to Optimize Fluid Bed Drying
This article shows how non-supervised artificial intelligence (AI) methods can strongly support…
PE Articles
Validation 4.0: Case Studies for Oral Solid Dose Manufacturing
Three case studies on Validation 4.0 demonstrate how quality by design (QbD) principles, when…
iSpeak Blog
Should Your Company Switch to Continuous Manufacturing?
As the benefits of continuous manufacturing became more apparent in the pharmaceutical industry…
PE Articles
Regulatory Aspects of Global Acceptance of Continuous Manufacturing
Application of continuous manufacturing (CM) in the pharmaceutical industry is gaining momentum…
PE Articles
Material Properties Databases to Advance Pharmaceutical Processing
Pharmaceutical manufacturers rely heavily on powder processes, the majority of which are designed…
Video
ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition)
Dave DiProspero, Co-Team Leader of the ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition)…
Basic page
2017 Category Winner for Facility of the Future and Overall Winner
Eli Lilly and Company Location: Indianapolis, Indiana, USA and Carolina, Puerto Rico Project…
Video
Driving Operational Excellence: Lean Six Sigma Integration in Complex CMO Operations
Driving Operational Excellence: Lean Six Sigma Integration in Complex CMO Operations Complimentary…
PE Articles
Process Validation Lifecycle for Packaging Oral Solid Dosage Forms
The ISPE Discussion Paper “Overview of Packaging Validation for Drug Products” explores the…
Product
Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition
The ISPE Baseline Guide: OSD Forms is intended to offer a tool for consistent framework for…
Product
Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
This Guide reviews the unit operations typically employed in continuous manufacturing and aims to…
PE Articles
ISPE Briefs: A Comprehensive Reference for Continuous Manufacturing of OSD
The pharmaceutical industry began applying the principles of continuous processing to the…
Guidance Documents
Advanced Manufacturing (1)
+Manufacturing Operations (2)
+Microbiological & Viral Contamination Control (1)
+Oral Solid Dosage (2)
+Community Discussions
Community Discussions
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Active Pharmaceutical Ingredients
Feb 13, 2025
Manufacturing Operations
Oral Solid Dosage
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
Pharmaceutical Engineering Magazine Articles
ISPE Briefs: A Comprehensive Reference for Continuous Manufacturing of OSD
The pharmaceutical industry began applying the principles of continuous processing to the…
Artificial Intelligence Used to Optimize Fluid Bed Drying
This article shows how non-supervised artificial intelligence (AI) methods can strongly support…
Validation 4.0: Case Studies for Oral Solid Dose Manufacturing
Three case studies on Validation 4.0 demonstrate how quality by design (QbD) principles, when…
Regulatory Aspects of Global Acceptance of Continuous Manufacturing
Application of continuous manufacturing (CM) in the pharmaceutical industry is gaining momentum…
Material Properties Databases to Advance Pharmaceutical Processing
Pharmaceutical manufacturers rely heavily on powder processes, the majority of which are designed…
ISPE Briefs: A Comprehensive Reference for Continuous Manufacturing of OSD
The pharmaceutical industry began applying the principles of continuous processing to the…
Artificial Intelligence Used to Optimize Fluid Bed Drying
This article shows how non-supervised artificial intelligence (AI) methods can strongly support…
Validation 4.0: Case Studies for Oral Solid Dose Manufacturing
Three case studies on Validation 4.0 demonstrate how quality by design (QbD) principles, when…
Regulatory Aspects of Global Acceptance of Continuous Manufacturing
Application of continuous manufacturing (CM) in the pharmaceutical industry is gaining momentum…
Material Properties Databases to Advance Pharmaceutical Processing
Pharmaceutical manufacturers rely heavily on powder processes, the majority of which are designed…
ISPE Briefs: A Comprehensive Reference for Continuous Manufacturing of OSD
The pharmaceutical industry began applying the principles of continuous processing to the…
Artificial Intelligence Used to Optimize Fluid Bed Drying
This article shows how non-supervised artificial intelligence (AI) methods can strongly support…
Validation 4.0: Case Studies for Oral Solid Dose Manufacturing
Three case studies on Validation 4.0 demonstrate how quality by design (QbD) principles, when…
Regulatory Aspects of Global Acceptance of Continuous Manufacturing
Application of continuous manufacturing (CM) in the pharmaceutical industry is gaining momentum…
Material Properties Databases to Advance Pharmaceutical Processing
Pharmaceutical manufacturers rely heavily on powder processes, the majority of which are designed…
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…
January / February 2024
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
November / December 2023
There is much that large-scale commercial stem cell therapy processes can adopt from the existing…
iSpeak Blog Posts
iSpeak Blog
Should Your Company Switch to Continuous Manufacturing?
As the benefits of continuous manufacturing became more apparent in the pharmaceutical industry…
Videos
Video
Driving Operational Excellence: Lean Six Sigma Integration in Complex CMO Operations
Driving Operational Excellence: Lean Six Sigma Integration in Complex CMO Operations Complimentary…
Video
ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition)
Dave DiProspero, Co-Team Leader of the ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition)…
Professional Development Training
ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
+GMP Sterile Pharmaceutical Manufacturing Facility Training Course
+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…