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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The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
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The commercialization of personalized medicine has ushered in demand for a new type of facility—…
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Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…
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Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
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There is much that large-scale commercial stem cell therapy processes can adopt from the existing…
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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
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…