RA
Site Master File in Pharmaceutical Industry
In the world of pharmaceutical manufacturing, understanding and maintaining high standards of quality is not just important, it’s imperative. A key element in this quality assurance landscape is the Site Master File (SMF), but what is it? An SMF is a comprehensive document that provides detailed information about the production ... Read More
ASEAN Common Technical Document (ACTD)
It is a submission format for dossiers used in most ASEAN countries (Association of South-East Asian Nations). The main aim of ACTD is to regulate the pharmaceutical regulations of the ASEAN member countries to complement and facilitate the objective of AFTA (ASEAN Free Trade Area), particularly, the elimination of technical ... Read More
Stability Data and Evaluation of Finished Pharmaceutical Products
Stability Studies: A Brief Introduction Stability studies are crucial for determining the shelf life and storage conditions of pharmaceutical products, ensuring their efficacy and safety throughout their lifespan. Long-term and accelerated studies are conducted to evaluate how products respond to various environmental conditions. Data from these studies help establish expiration ... Read More
Regulatory Guidelines for CSV
Embarking on the path to a successful Computer System Validation (CSV) roadmap begins with a solid understanding of the applicable regulatory requirements within your industry and region. Investing the time to understand which regulations you must comply with, which are advantageous, and which, are the gold standard, is a crucial ... Read More
Patents and Exclusivity in Pharmaceutical Industry
Did you know that “patent” and “exclusivity” are two of the most commonly searched terms on the FDA website? Generics account for more than 80% of prescription drugs in the US, and that number continues to grow. With approaching patent expirations of several top selling prescription brand-name drugs, sponsors of ... Read More
Drug Master File (DMF) in Pharmaceutical Industry
Drug Master File (DMF) is a package of confidential, proprietary assets, specifying the formula, processes, materials, test methods, and other information relevant to the manufacture of product used in the composition, packaging, and/or processing of pharmaceuticals and/or biologics. Types of DMFs Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel ... Read More