An Analysis of GxP Audit Procedures and FDA Inspection Readiness Strategies GxP audits are necessary in the pharmaceutical industry to ensure that operations comply with global regulatory standards, especially those established by the U.S. Understanding audit procedures and inspection readiness is essential for organizations involved in or supporting pharmaceutical manufacturing and R&D to ensure compliance… Continue reading An Analysis of GxP Audit Procedures and FDA Inspection Readiness Strategies
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The Importance of GMP Audits in Ensuring Product Safety and Quality
The Importance of GMP Audits in Ensuring Product Safety and Quality Regardless of the industry, maintaining high standards of quality and assuring product safety is paramount to perform successfully, make profit and avoid mistakes. In the pharmaceutical sector protecting the patient’s safety and credibility requires performing Good Manufacturing Practices (GMP) audits. GMP custom made audits… Continue reading The Importance of GMP Audits in Ensuring Product Safety and Quality
The Egyptian Drug Authority begins today to activate the electronic payment service through its official website
The Egyptian Drug Authority begins today to activate the electronic payment service through its official website The Egyptian Drug Authority announced the start of activating the electronic payment service through the official website of the Authority, as part of its continuous efforts towards digital transformation and enhancing the efficiency of the services provided, which contributes… Continue reading The Egyptian Drug Authority begins today to activate the electronic payment service through its official website
Egypt Joins EDQM’S OMCL Network as an Associated Member
Egypt Joins EDQM’s OMCL Network as an Associated Member: A Leap Forward for Global Medicines Quality Control Masuu Global is proud to highlight a significant milestone in international pharmaceutical collaboration: The BIO INN Laboratories of the Egyptian Drug Authority (EDA) have joined the General European OMCL Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines &… Continue reading Egypt Joins EDQM’S OMCL Network as an Associated Member
Effective Preparation for Pharmacovigilance Inspections: Key Steps for MAHs
Effective Preparation for Pharmacovigilance Inspections: Key Steps for MAHs Pharmacovigilance (PV) inspections are a crucial part of ensuring public health safety within the European Union (EU). These inspections are conducted by national competent authorities in cooperation with the European Medicines Agency (EMA) to verify that marketing authorisation holders (MAHs) are meeting their pharmacovigilance obligations.
Health Canada’s Mandatory XML Product Monograph Rule Takes Effect July 18, 2025
Health Canada’s Mandatory XML Product Monograph Rule Takes Effect July 18, 2025 Change in Filing Requirements for XML PM? Health Canada is making Structured Product Monograph (SPM) submissions in XML format mandatory starting July 18, 2025, for select drug applications. This move is part of Canada’s broader effort to modernize regulatory submissions and improve drug… Continue reading Health Canada’s Mandatory XML Product Monograph Rule Takes Effect July 18, 2025
USFDA Food Compliance 101: Key Requirements for Manufacturers and Importers
USFDA Food Compliance 101: Key Requirements for Manufacturers and Importers When it comes to selling or distributing food products in the United States, compliance with the regulatory requirements of the U.S. Food and Drug Administration (USFDA) is essential. The FDA is responsible for ensuring the safety, labeling accuracy, and quality of food products to protect… Continue reading USFDA Food Compliance 101: Key Requirements for Manufacturers and Importers
Complying with Canadian Food Safety and Labeling Standards: A Regulatory Overview
Complying with Canadian Food Safety and Labeling Standards: A Regulatory Overview For businesses involved in the marketing or distribution of food in Canada, businesses must comply with the regulatory framework set by Health Canada and the Canadian Food Inspection Agency (CFIA). These regulations ensure that food sold in Canada is safe, properly labeled, and nutritionally… Continue reading Complying with Canadian Food Safety and Labeling Standards: A Regulatory Overview
MHRA’s Decentralised Manufacture Designation – Regulatory Framework
MHRA’s Decentralised Manufacture Designation – Regulatory Framework An overview of designation criteria, submission steps, and compliance considerations for POC and modular manufacturing
Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials : EMA Initiates Consultation on New Clinical Trial Guidance
Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials : EMA Initiates Consultation on New Clinical Trial Guidance The European Medicines Agency (EMA) invites public feedback on a new draft guideline focused on including pregnant and breastfeeding populations in clinical trials, addressing critical gaps in medicine safety and efficacy data. The consultation is open until… Continue reading Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials : EMA Initiates Consultation on New Clinical Trial Guidance