Oral Solid Dosage (OSD) is the inspection and evaluation of the manufacturing and control processes used to manufacture solid oral dosage form pharmaceutical products.
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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…
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)…
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2017 Category Winner for Facility of the Future and Overall Winner
Eli Lilly and Company Location: Indianapolis, Indiana, USA and Carolina, Puerto Rico Project…
Guidance Documents
Advanced Manufacturing (1)
Manufacturing Operations (2)
Microbiological & Viral Contamination Control (1)
Community Discussions
Community Discussions
Jun 13, 2024
Information Systems
Regulatory
Advanced Manufacturing
Active Pharmaceutical Ingredients
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
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…
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…
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
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. Buy Now Return to…
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
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…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…