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
Newly published ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing (CM) of Solid Dosage Forms (OSD) Helps Support Broader Adoption of CM
Continuous manufacturing (CM) of oral solid dosage forms has become a well-established approach that…
Product
Good Practice Guide: Control Strategy Development for CM of OSD Forms
Published: October 2025 Pages: 72 Table of Contents Special Pricing for Emerging Economies…
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…
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Guidance Documents
Advanced Manufacturing (1)
Manufacturing Operations (3)
Microbiological & Viral Contamination Control (1)
Oral Solid Dosage (3)
Process Analytical Technology (1)
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Oral Solid Dosage
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…
White Papers
November / December 2025
In This Issue: We dive into sustainable practices in the pharma industry and effective ways to…
September / October 2025
As regulatory trends and quality initiatives continue to evolve in the pharmaceutical industry, this…
July / August 2025
The AI Paradox Cover: The increasing digitalization of the pharmaceutical and medical device…
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…
iSpeak Blog Posts
iSpeak Blog
Newly published ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing (CM) of Solid Dosage Forms (OSD) Helps Support Broader Adoption of CM
Continuous manufacturing (CM) of oral solid dosage forms has become a well-established approach that…
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
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 Sterile Pharmaceutical Manufacturing Facility Training Course
This course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities.
White Papers
November / December 2025
In This Issue: We dive into sustainable practices in the pharma industry and effective ways to…
September / October 2025
As regulatory trends and quality initiatives continue to evolve in the pharmaceutical industry, this…
July / August 2025
The AI Paradox Cover: The increasing digitalization of the pharmaceutical and medical device…