Author: masuuglobal
IMPLEMENTATION OF THE EUROPEAN PHARMACOPOEIA SUPPLEMENT 12.3
IMPLEMENTATION OF THE EUROPEAN PHARMACOPOEIA SUPPLEMENT 12.3 Publication schedule: Issue Publication date Correction date Implementation date 12.1 07/2025 31/08/2025 01/01/2026 12.2 10/2025 30/11/2025 01/04/2026 12.3 01/2026 28/02/2026 01/07/2026 13.1 04/2026 31/05/2026 01/01/2027 13.2 07/2026 31/08/2026 01/04/2027
What Is an Investigational Device Exemption (IDE)?
What Is an Investigational Device Exemption (IDE)? Enabling Clinical Trials for Medical Devices in the U.S. If you intend to sell a medical device in the United States, it is necessary to prove it is safe and operates as intended. Before doctors can test a new device on people, the company behind it usually needs… Continue reading What Is an Investigational Device Exemption (IDE)?
What Is an ICSR
What Is an Individual Case Safety Report (ICSR)? A Key Component of Pharmacovigilance Pharmacovigilance plays a vital role in overseeing the safety of medicinal products during the lifecycle of the products. The Individual Case Safety Report (ICSR) is considered to be one of the most significant tools that are employed to monitor and analyze adverse… Continue reading What Is an ICSR
What Is an IMPD?
What Is an IMPD? Understanding the Investigational Medicinal Product Dossier Regulatory approval is a pre-requisite prior to initiating any clinical trial that involves any medicinal products in the European Union. Among the most significant papers needed in this procedure is Investigational Medicinal Product Dossier (IMPD).
What Is a PADER?
What Is a PADER? Understanding the Periodic Adverse Drug Experience Report Pharmacovigilance plays a critical role in ensuring patient safety throughout a product’s lifecycle. One of the key regulatory requirements in the United States is the Periodic Adverse Drug Experience Report (PADER). This report allows regulatory authorities to continuously evaluate the safety profile of approved… Continue reading What Is a PADER?
What is GMP Inspection?
What is GMP Inspection? In the healthcare and pharmaceutical sectors, Good Manufacturing Practices (GMP) are the foundation of quality and safety of their products. A GMP inspection is a systematic exercise which is conducted by regulatory authorities like FDA ( United States Food and Drug Administration), EMA (European Medicines Agency) or WHO (World Health Organization).
Global GMP & Regulatory Intelligence 2025–2026
Continent-Specific Global GMP and regulatory compliance Updates for API & Pharmaceutical Manufacturers Introduction Regulatory authorities worldwide are strengthening expectations around GMP robustness, quality maturity, contamination control, data integrity, and AI governance in pharmaceutical manufacturing. Global GMP and regulatory compliance updates across Africa, North America, Europe, Asia, and Oceania are increasingly aligned with ICH, PIC/S, WHO,… Continue reading Global GMP & Regulatory Intelligence 2025–2026
What is an FDA Warning Letter?
What is an FDA Warning Letter? An FDA Warning Letter is basically the FDA’s way of telling a company, “You broke the rules, and we noticed.” When the FDA spots a serious violation of federal laws or regulations, they send this letter straight to the company. It’s not just a head-up, it’s a demand for… Continue reading What is an FDA Warning Letter?
What is GMP Compliance Audit?
What is GMP Compliance Audit? When it comes to pharmaceuticals, food, or cosmetics, making sure products are safe and high-quality isn’t just a box to check it’s something companies owe to everyone who uses their products. That’s where a GMP Compliance Audit steps in. Auditors dig into every part of the manufacturing process, starting with… Continue reading What is GMP Compliance Audit?
Designing a GMP Production Facility for Quality and Compliance
Designing a GMP Production Facility for Quality and Compliance A Good Manufacturing Practice (GMP) production facility is not merely a building constructed; rather a system that ensures product quality, safety and compliance to regulations. GMP is extremely important in such industries as pharmaceuticals, biotechnology and nutraceuticals to safeguard consumers and ensure brand integrity.