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Batch Manufacturing Records

15 December, 2024 admin 0 Comments

Batch Manufacturing Records Introduction to Batch Manufacturing Records (BMR) Batch Manufacturing Records (BMR) are the backbone of pharmaceutical manufacturing. These documents capture every detail of the production process, ensuring consistency, traceability, and compliance with regulatory…

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Dissolution Testing in Pharmaceuticals (USP <711>)

17 November, 2024 admin 0 Comments

What is Dissolution Testing? Dissolution testing measures how quickly and completely a drug dissolves in a particular solvent. The United States Pharmacopeia (USP) standard for dissolution testing, known as USP <711>, provides guidelines to ensure…

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ICH Guideline

2 November, 2024 admin 0 Comments

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…

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CTD Modules for the West African Pharmaceutical Market

25 September, 2024 admin 0 Comments

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…

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ICH Quality Guidelines

17 September, 2024 admin 0 Comments

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…

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Registering Pharmaceutical Products in Nigeria

17 September, 2024 admin 0 Comments

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…

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GMP Regulations in Nigeria

15 September, 2024 admin 0 Comments

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…

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The CTD Unveiled: Your Guide to Quality Standards

15 March, 2024 admin 0 Comments

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…

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