Oral Solid Dosage (OSD) is the inspection and evaluation of the manufacturing and control processes used to manufacture solid oral dosage form pharmaceutical products.
Guidance Documents
Advanced Manufacturing (1)
Manufacturing Operations (2)
Microbiological & Viral Contamination Control (1)
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Community Discussions
Jun 13, 2024
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Active Pharmaceutical Ingredients
Pharmaceutical Engineering Magazine Articles
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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…
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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—…