Drug Master File
Watch the full video for an in-depth explanation on YouTube https://youtu.be/TA2-v7UYZm8
Watch the full video for an in-depth explanation on YouTube https://youtu.be/TA2-v7UYZm8
Watch the full video for an in-depth explanation on YouTube. https://youtu.be/Gek2Eu_ps6s
Q1/Q5C EWG Targeted Revisions of the ICH Stability Guideline SeriesQ10 Pharmaceutical Quality SystemQ11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)Q11 Q&As Questions & Answers: Selection and Justification of Starting Materials for…
In the pharmaceutical industry, it is critical to ensure that testing methods are accurate, reliable, and suitable for their intended purpose. USP <1225> and USP <1226> provide guidelines to achieve this by focusing on the…
The West African Health Organization (WAHO) has adopted the Common Technical Document (CTD) format to standardize the registration of pharmaceutical products across the Economic Community of West African States (ECOWAS). This format helps pharmaceutical companies…
The International Council for Harmonisation (ICH) is a global organization that plays a key role in ensuring that medicines are safe, effective, and high quality. It brings together regulatory authorities and the pharmaceutical industry from…
The Drug and Related Product Labelling Regulations, 2021, introduced by Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), lay down the rules for the labeling of drugs and related products. These regulations…
If you're looking to register pharmaceutical products in Nigeria, understanding the process and requirements can seem daunting. However, with a clear step-by-step approach, you can navigate the registration process more easily. Here’s a simplified guide…
When it comes to medicines, safety and quality are non-negotiable. In Nigeria, the Good Manufacturing Practice (GMP) Regulations ensure that pharmaceutical products are produced with the highest standards of quality and safety. Introduced by NAFDAC…
Welcome to our guide on the Common Technical Document (CTD) quality standards, where we make sense of the rules for pharmaceutical submissions. If you've ever felt lost in the maze of regulations, fear not! We're…