Oral Solid Dosage (OSD) is the inspection and evaluation of the manufacturing and control processes used to manufacture solid oral dosage form pharmaceutical products.
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)…
Video
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies Extended…
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…
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)…
Video
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies Extended…
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…
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Guidance Documents
Advanced Manufacturing (1)
+Manufacturing Operations (2)
+Microbiological & Viral Contamination Control (1)
+Oral Solid Dosage (2)
+Community Discussions
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Apr 16, 2025
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Nov 04, 2024
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Oct 31, 2024
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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
May / June 2025
The ATMP Issue: In this issue, we focus on the manufacturing of advanced therapy medicinal products…
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…
September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of…
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
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies Extended…
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
May / June 2025
The ATMP Issue: In this issue, we focus on the manufacturing of advanced therapy medicinal products…
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…